Jobs That Crossed My Desk Through Sept
Jobs That Crossed My Desk Through March 22, 2010
Contact the person whose information appears at the top of each listing. Listings of each executive search person are separated by string of stars. Multiple listings submitted by one recruiter are separated by straight lines.
************************************************************************
Ten positions were posted on CACO Free Job Links website ()since last newsletter was distributed (late February). The summary of those positions is attached to this email.
Employer Position
Genentech Scientist - DMPK
Relypsa Research Associate / Analytical Development
Onyx Pharmaceuticals Scientist 2, DMPK
Onyx Pharmceuticals Associate Scientist/Scientist Process Development
Spherion On-site at Janssen Alzheimer's Immunotherapy (temporary project through the end of 2010) Quality Control Manager/Analyst
Formurex, Inc. Analytical Scientist
Theravance, Inc. QC Analyst, Analytical Development
Aragon Pharmaceuticals Research Associate, Bioanalytical/In Vitro ADME
Full Spectrum Analytics, Inc. Field Service Specialist,LC/MS
On Assignment, Lab Support Chemist II
***********************************************************************
New Career Opportunities at careers.
Pfizer, Astellas, Med Exec International, i3 and ClinForce are just a few of the industry leaders using careers. every day to find professionals like you. Check back often for new job postings!
To view the 1,721 jobs posted on careers. click here.
|Browse Jobs by Category |
|Account and Media Management |
|Advertising/Promotion Management |
|Business Development/Strategic Planning |
|Chemist |
|Clinical Operations and Development |
|Corporate Research |
|Consulting |
|Corporate Management |
|Engineer |
|Finance Management and Auditing |
|Information Technology |
|Lab Management/Technician |
|Manufacturing |
|Market Research/Academic Research |
|Marketing Management |
|Product/Brand Management |
|QA/QC |
|R&D |
|Sales |
|Regulatory/Government Affairs |
|Training and Development/HR |
**********************************************************************
Cindy Keefer, President
Keefer Healthcare Recruiting, Inc
Encinitas, CA 92024
(760) 632-2430 office
CKeefer@
Perhaps you know of someone who’d like to learn more of these positions….With so much volatility in the pharma industry; I hope you & your industry friends will appreciate this information. Thank you in advance for taking the time to review this & I appreciate your networking efforts.
SPECIFIC SKILL SETS ARE IDENTIFIED:
GOVT / POLICY
ASSOC DIRECTOR, GOVT AFFAIRS – to reside in CA/ DC (will relo) Proficient Coverage & Reimbursement Policy expertise for public payer strategies including coverage, coding, and payment policies at the natl and regional/local level. Will lead team members in assessing and communicating-to internal and external stakeholders-key policy issues that may impact biotech products. Expertise w/ patient trends, access and policy development / communication efforts with key government agencies and organizations including HHS, CMS, AHRQ, IOM, and NQF; heavy internal stakeholder interface
2 CA RAMS (No. CA & So. CA) must have anti-psychotic/psychiatry background. Public Health relationships MUST exist – ie LA County behavioral health, mental health facilities & some advocacy; some contracting. Excellent compensation!
RAM – to reside in CA. key relationships: BS CA, MEDI-CAL, HMSA & some IPAs - Healthcare Partners, Brown &Toland, Sutter &managed Medicaid plans - IEHP & Cal Optima
RAM – NJ/PA/WV/VA/KY/DE/NC MCO/PBM focus
ACCOUNT MANAGER – near NYC/NJ/upper PA or Orlando, FL zone specialty background preferred – calling on pharma & MCO / health plans
NAM – 10 Midwest states – preferred residence Chicago/Minneapolis/St. Louis. Specialty background preferred – state Medicaids &BCBS plans, Prime Therapeutics & BCBS Association relationships
NAM (GPO/IDN/MCO/MEDICARE/MEDICAID & SOME EMPLOYER GROUPS) – to reside Detroit / Cleveland / Columbus to cover IN/KY/MI/OH 60% travel
IDN ACCOUNT MANAGERS – 20 new positions across the a combination of US areas: AZ, BOSTON, CA, CO, DALLAS, DC/MD, GA, FL, KS, IL, NY/NJ/CT, OH, PA, MI, TN, UT, WA
CLINICAL
MSL – Los Angeles- preferred or San Diego, CA preferred. Must be PharmD/MD/PhD with at least 1 yr of MSL experience. Will work w/ KOLs & MCOs
REIMBURSEMENT
SR, REIMBURSEMENT MANAGER – to reside with Midwest (MT, WY, MN, IL, ND. NE, MO WI, IA, TX, KS, OH, KY, TN) for implementing reimbursement coverage and health policy strategies and tactics for biotech agents
CMS REIMBURSEMENT MANAGER – NC (will relo). WILL BE INVOLVED IN ALL CORE COMPANY MEETINGS & STRATEGY DEVELOPMENT & MAY EVENTUALLY LEAD A TEAM. Provides US level CMS (state & federal) reimbursement and strategy development, with thorough knowledge of CMS regulations, contracting, government rebate regulations, pricing, and third party payor agreements. Expertise w/ legal terminology of contracts, CMS coding forms (ex. HCPCS 1500), state Medicaid provider regulations, and provide guidance to Sales and Marketing. Thorough knowledge of various sites-of-care (including hospital inpatient and outpatient settings, physicians' offices, infusion centers, patient’s, etc.) and how each effect reimbursement.
DIRECTOR PATIENT CASE MANAGEMENT/REIMBURSEMENT – to reside in MA (will relo). Technical & team leadership skills are important. Will lead a team of 9 Case Managers (40 total with downline) that assure patient care / access process within regions. Will lead and develop the patient care coordination function and metrics to ensure measurement and quantitative assessment. Must have insights to MM payor channels, prior team leadership & strategic insights to patient assistance / coverage & effective case management strategies / tactics. Ensure accurate, reliable case management data to support business decisions. Biotech background essential
MM TEAM MANAGEMENT
DIRECTOR US MM – FL will lead 6 Specialty Account Managers
PRICING / REIMBURSEMENT - LEADERSHIP
DIRECTOR GLOBAL PRICING -to reside in NJ/NY/CT (will relo) –MUST HAVE GLOBAL PRICING background & oncology expertise is preferred, highly analytical. Provides strategic leadership & functional lead for team. Background in WW health outcomes, marketing exposure, financial modeling, performs pricing analysis on early stage compounds & licensing, shapes future direction for pharma org. Interfaces with early stage development drug development teams, optimizes value proposition & market access strategies that support commercialization strategy. Interfaces with global & MM teams, pricing / reimbursement, strategic planning/decision analysis, outcomes research. Reports to VP Pricing (highly visible position)
CONTRACTING
GOVT ANALYST – to reside in No. CA great financial package & relo but MUST have VA/DoD expertise
MM CONTRACTING & ANALYTICS MANAGER – to reside in No. CA. Govt & Commercial contract expertise – monitors, analyzes, creates measurement templates impacting contract performance, reimbursement & rebate decisions. Must be strong w/ compliance, federal /state laws & segment trending re pricing programs and related agencies (CMS, States, PHS, FFS, IFF, TriCare, etc.); must be proficient w/ analytic tool development & implementation
SR. MANAGER MC CONTRACTING – CT/NJ/NY (will relo). Commercial and Medicare Part D pricing strategies, contract administration
MM MARKETING
MM MARKETING - to reside in NJ & Chicago with IDN / biotech
SR. MANAGER MEDICARE, MM MARKETING - CT/NJ/NY: Medicare / CMS / Medicaid expertise Must have marketing experience with ability to develop Medicare / CMS segment strategies, objectives & execution of strategic plans; ability to interpret market research & understand the regulatory environment
SR. MANAGER, MM MARKETING – MA (will relo). MC Marketing with a mix of but not all: Federal & State/Commercial & Medicare Part D/IDN/ Trade & Wholesale & Specialty Pharmacy; possible disease management. The preferred candidate might have a mix of skill sets that will determine how the current team will function & focus
SR. MANAGER TRADE MM MARKETING – to reside in TX. Must have Consumer & OTC marketing expertise at Sr. levels. Strong strategist, as well tactical planning skills; to work with Trade NAMS to implement pull-thru to wholesalers & retail. Liaison to corporate Europe
MARKETING
SR. PORTFOLIO MARKETING MANAGER (Hospital Products) – to reside in CA (will relo). Highly visual & strategic, can develop the department. Expertise within Managed Markets (family ofhospital products), knowledge of contracting, field implementation plans/tools/pieces, analytics / market research & activities w/ advisory boards; skilled marketing plan development – 3 yr long rang/1yr tactical, to manage budget. Highly visual position w/ significant interface among marketing, medical affairs, contracting, MM & field teams. Will be able to invent innovative activities
MARKETING / PUBLIC AFFAIRS
SR. MANAGER PUBLIC AFFAIRS – to reside in CA. Will develop and implement strategic, media, patients and healthcare provider’s communications. Will interact in advocacy organizations / manage communications programs for pipeline and marketed products. Will serve as a media spokesperson for the company, and will frequently interact with and advise senior management. Immunology background is desired. Will have some interface in clinical trial design, drug Assist with the development of long-term grant strategy & budgets; lead the execution of annual grants cycle, track grants and evaluate effectiveness of Public Affairs programs
*********************************************************************************************************************
Clinical Trial Research Process Management Associate
PLEASE APPLY DIRECTLY AT (AS SHOWN IN THE EMAIL BELOW):
.edu/rmg/ jobs.html
Job ID 37513
Job Location School of Medicine
Job Category Research
Salary 1A4
Date Posted Mar 12, 2010
The Clinical Trial Research Process Management Associate (CT RPMA) is a Research Management Group team member, reporting to the RMG Associate Director, Clinical Research Administration. The position is one of two CT RPM Associates responsible for a distinct portion of the pre- and post-award administration activities specifically for clinical trials and works closely with an assigned set of Clinical Trial Research Process Managers (CT RPMs) to support the sponsored projects research administration process, from beginning to end, in the School of Medicine.
DUTIES: Clinical Trial Contract Administration and Quality Assurance:
Facilitate compliant and timely parallel processing for clinical trial contracts between RMG, Office of Sponsored Research (OSR) Contracts Office, Research Compliance (IRB), SPCTRM, Cancer Clinical Trials Office (CCTO) and School of Medicine departments, as follows: Review clinical trial submission packages for completeness (sponsor contract, protocol, consent form, IRB submission, etc). Assess what else is needed and communicate via "intake" email to PI/Coordinator; follow-up as needed to obtain all required materials, retrieve IRB submission packet from IRB database as needed. Establish file record in SPIDERS, log record in ACCESS database, and create working files for the CT RPM. Photocopy and process required forms to OSR Contracts Office, as needed. Review and check all clinical trial budgets created by CT RPMs, for accuracy and completeness. Verify formula and calculations, salaries, hospital prices, CPT and procedure codes, discounts, effort,
indirect cost and fringe benefit rates, utilizing Excel spreadsheets, University systems (IDX, CDM, SPIDERS), and web resources. Involves creating a detailed verification spreadsheet of the budget provided by the CT RPM or department staff. Resolve discrepancies with CT RPM. Monitor compliance with University regulations by verifying Human Subjects training, PI training, Human Subjects approval. Complete the Human Subjects Training verification form for the working file. Initiate, route, track and follow-up on SU-42's to obtain all required signatures; verify that the SU-42 data is complete and matches/reflects how the contract was ultimately submitted, resolve discrepancies with the CT RPM. Update SPIDERS and the ACCESS Database. Assist the CT RPMs in coordination of workflow timelines for orderly and timely processing of all activities. Create maintain/modify/ update process checklists, informational lists, and other related documents, on server for
use by the CT RPM. Compile relevant final document package for Associate Director review and signature. Forward final budgetary and other compliance documents to OSR Contracts Office for inclusion in the complete University auditable file. Maintain and distribute assignments matrix. Communicate and interact with staff and other divisions in the SoM and in other University offices, as part of the CT Team for information updates and process clarification. Create, revise, update spreadsheets, forms, CT tools and reports as needed. Provide back up for CT RPMA, especially to meet deadlines and during absences. Type, file, photocopy, fax scan, etc. as needed.
QUALIFICATIONS: Two-year college degree or equivalent, four-year college degree preferred; minimum of 2-3 years related experience. Demonstrated advanced Excel and spreadsheet interpretation skills, including the creation and use of Excel formulas; strong math aptitude. Strong aptitude for learning new programs and systems. Experience with financial data with analytical aptitude; Meticulous attention to detail; Demonstrated excellent organizational skills with the ability to work under deadline pressure and efficiently prioritize tasks with frequent interruptions; Strong oral and written communication skills with the ability to use tact, diplomacy and discretion in all interactions, especially with sensitive and/or confidential material. Flexibility and a positive approach toward change. Working knowledge of the research administration processes is desirable. Working knowledge of University systems (such as PRISM, SPIDERS) is helpful. Experience with
budget development.
******************************************************************
Contact
Peter E. Cohan
The Second Derivative
1538 Winding Way
Belmont, CA 94002
Telephone: +1 650 631 3694
Email: PCohan@
Website:
Blog:
We need immediate help with some Marcom projects on a contractor basis, with success would turn into a full time job. Know any dynamic people with a genomics/biomarker/translational medicine vocabulary?
In particular, I understand company needs to have 1-pager-type materials prepared by April 15, in time for BioIT World. Can anyone fill the bill or know of anyone who can do an excellent job?
****************************************************************
Jobs That Crossed My Desk Through March 15, 2010
*******************************************************************
Contact:
Shannon Peryea
Vice President, Executive Recruiting
Sheila Greco Associates, LLC
174 State Hwy 67
Amsterdam, NY 12010
(518) 843-4611 ext. 252
shannonp@
sheilagreco. com
Scientific Directors
NY, PA, and OH
All openings are in medical communications or pharma advertising agencies. Full-time positions are on-site (no telecommuting).
_________________________________________________________________________
Copywriters (Copywriter Supervisor, Sr Copywriter, and Copy Director)
NJ and PA
At all levels, these openings are in medical communications or pharma advertising agencies. Full time and on site (no telecommuting).
_______________________________________________________________________
Proofreader/Editor – NJ
In medical communications or pharma advertising agencies; position is full time and on site (no telecommuting.
_______________________________________________________________
Associate Medical Directors
NY and NJ
In medical communications or pharma advertising agencies; positions are full time and on site (no telecommuting).
***************************************************************************
Contact
Tim Whiting, Boehringer Ingelheim Recruiting Partner
tim.whiting@
610-263-3030 Ext 4150
Interested candidates should call me directly at 610-263-3030 ext. 4150 and send their resume to me at tim.whiting@.
Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) is seeking a Scientist III in Protein Expression to join our Structural Research Department at our US headquarters in Ridgefield, CT.
As a Scientist III in Protein Expression you will:
- Develop and execute baculoviral and E. coli recombinant protein expression strategies to support the protein needs of fragment-based screening (FBS), crystallization, protein NMR and other biophysical studies.
- Maintain viral stocks and prepare cell lines for scale-up expression.
- Execute parallel purification strategies on multiple constructs in small scale towards biophysical characterization of these proteins.
- Provide molecular biology support for protein clone and vector design.Coordinate external requests for construct synthesis and biomass production.
REQUIREMENTS:
- B.S. or M.S. in protein biochemistry, protein biophysics or related discipline.
- 4+ years post-degree, hands-on work experience in the area of baculoviral recombinant protein expression for assay development, biophysical (fluorescence, SPR) studies, and/or structural (X-ray, NMR) studies.
***************************************************************************
If you have interest in speaking to either company please let me know and send me an updated resume.
David Obad
Managing Partner
NCompass Recruiting Services, LLC
Office: 415.738.7878 x 104
Below is the company information.
Marketing Manager - Align Technology, Inc. () is a global medical-device company that pioneered the invisible-orthodontics market with the introduction of the Invisalign® system, a clear, removable orthodontic-treatment option for straightening teeth. Invisalign products combine proprietary software and a series of medical-grade plastic appliances called “aligners” to move teeth in stages as determined by the treating doctor.
This is what the hiring manager had to say: “Consumer Marketing team is myself and another Sr Marketing Manager. We are supported with a larger team including a Creative/Digital agency, Media agency and PR agency. Overall Marketing is about 25 people. No direct reports as of now. Must be very strong in Digital (social media, traditional banner, SEO, etc) strong analytics and results oriented (and have demonstrated results in past). Consumer DTC experience is a must-have. Aesthetic or cosmetic brands a bonus.”
___________________________________________________________________________
Product Manager - Cutera () was founded in 1998 with a goal of becoming the worldwide leading provider of laser and other light-based aesthetic systems to the aesthetic market. With our easy-to-use products, dermatologists, plastic surgeons, gynecologists, primary care physicians and other qualified practitioners can offer safe, effective and non-invasive aesthetic treatments to their patients. Current applications of our product family include: permanent hair reduction on all skin types and tanned skin; treatment of vascular conditions, including leg and facial veins; a wide range of non-ablative skin rejuvenation applications; and the treatment of pigmented lesions.
They have about 100 employees in Brisbane and 10 people in their Marketing group (3 Product Managers).
********************************************************************
Contact:
Amy E. Fink
Clinical Recruiter
MedFocus, LLC.
Built to FIT
An inVentiv Health Company (NASDAQ: VTIV)
Clinical Publications Lead – Wilmington, DE
A Major Pharmaceutical Company is looking for a Clinical Publications Lead in Wilmington, Delaware.
Number of years work experience required: 5
Description:
The primary accountability and responsibility for this position is the development of US publication strategies and plans and the delivery of US-focused medical, scientific and technical publications. Candidates for this position must be able to lead cross functional teams to develop innovative publications strategies and plans, work with senior colleagues and external investigators and authors to deliver publications to time and quality, represent US team interests globally to ensure alignment of global and US publications strategies and plans, ensure compliance with the company Publications Policy and efficiently manage our external agencies and suppliers.
Major Responsibilities:
• Delivers US-specific publication plans
• Ensures that statements and conclusions in publications are supported by appropriate data
• Provides leadership of cross-functional US Product Publications Delivery Team charged with delivering the US Publication strategy and plan
• Consults and liaises with external authors on matters related to publications activities
• Identifies and manages publications agencies through the effective use of project management skills to ensure the delivery of quality documents
• Edits, as appropriate, publications deliverables (eg, manuscripts, abstracts, posters)
• Participates in the negotiation and management of US publication budgets with US product team
• Works closely with the Global Publication Manager on all aspects of publication planning and delivery, eg, directs and manages the US review of non-US components of the global publication plan
• Contributes US perspective to the definition of the global product publication strategy and plan (in conjunction with the US and global publications teams for a product)
• Interprets and monitors current and emerging clinical communication issues and guidelines and advises the US Product Team on these issues
Minimum Requirements:
• Baccalaureate degree in biomedical discipline or equivalent
• Knowledge of the drug development process, human pathophysiology, and diseases
• Excellent written and oral communication skills, manifested as the ability to express medical information accurately, clearly, and succinctly
In-depth knowledge of, and experience (5 to 7 yrs) in the preparation of a wide range of
• publication types (eg, peer-reviewed journals, scientific meetings and congresses)
• Demonstrated ability to manage several projects simultaneously, including dealing with risk and issue management
• Knowledge of external publication guidelines and standards
• Able to travel nationally and internationally
• Able to work effectively in a cross-cultural business environment
• Influencing and negotiating skills
Preferred Background:
• Advanced biomedical degree
• In depth experience (7 to 10 yrs) in publication management
• Demonstrated budget and resource management skills
• Previous experience in TA areas of Company
• Awareness of pharmaceutical business practices
• Knowledge of competitors and competitor products
• Editor in Life Sciences (ELS) certification
**********************************************************************
Jobs That Crossed My Desk Through March 6, 2010
*********************************************************************
Julie@
650-520-3433
I have a client looking for a Sr QA Manager/ Associate Director QA. It is possible it could be consultant to perm. I don't have further information at this time but am assuming they require a Generalist (eg typically these are more CMC GMP vs clinical GCP). Someone at the right level is important as this will correlate with the experience they want and the rate they are willing to pay.
********************************************************************To Apply
To apply for a Regional Account Manager position for a location listed above, please click on the following link and submit your resume to Leslie Gaber and Associates:
Regional Account Manager
Description
The Regional Account Manager will be responsible for achieving all assigned objectives for the PreDx Diabetes Risk Test (and additional products to follow). In order to achieve objectives the Regional Account Manager must be skilled at the creation and execution of regional business plans, have an ability to quickly establish effective relationships with Key Opinion Leaders (endocrinology/cardiology/diabetology), influence others, and create and manage a growing customer base of primary care physicians. The Tethys Regional Account Manager will be known to his/her customers, peers and supervisor as a person who consistently exceeds goals, will be a leader within the Company and the medical community, will be a person of integrity, and will be diligent and consistently successful.
Locations Needed
• Chicago, IL
• St. Louis, MO
• Lexington, KY
• Baltimore, MD
• Atlanta, GA
• Pittsburgh, PA
Essential Duties and Responsibilities:
• Creation and execution of business plan that will result in achieving/exceeding all objectives.
• Creation and maintenance of strong business relationship with Key Opinion Leaders and other influencers in assigned geography.
• Building and maintaining a strong customer base.
• Successful engagement with all who influence the successful adoption of PreDx (and other Tethys products).
Education, Experience and Key Competencies
• Bachelor’s Degree and a minimum of 5+ years of work experience in successful introduction of new, high value pharmaceuticals or diagnostic tools with a focus on the physician and payer as major stakeholders/customers.
• Demonstrated ability to communicate complex scientific findings in a manner that is appropriate and compelling to the intended audience(s).
• Proven track record in achieving sales performance objectives.
• Demonstrated ability to introduce new, innovative products and achieve market adoption.
Physical/Mental Requirements
• Travel approximately 30% of the time.
• Occasionally move up to 20 pounds.
• Ability to interpret and/or analyze complex data and information.
• Ability to coordinate multiple tasks simultaneously.
• Ability to concentrate on technical and/or financial data/information for long periods of time.
************************************************************************
Contact:
James Zeigler, Headhunter
Odom Lewis
Medical Communications Practice
904.223.0213 xt221
904.563.4244 m
904.223.0235 f
Jzeigler@
One of our best clients has critical needs in their marketing department and are looking for talented candidates with experience in ENT, Urology, Gastroenology, or Endoscopy.
Some Key highlights.
1. San Francisco based opportunity and the client is open to relocation
2. Global responsibility
3. Job Description for ENT is attached. Urology, Gastro, and Endoscopy have similar responsibilities
4. Strong in both Upstream and Downstream marketing
5. Product development experience and technical or science background is a plus
6. Ability to communicate with R&D regarding complex technology for product improvement.
Any help you can provide by passing this information through your network or sending referrals is greatly appreciated.
ENT / Head and Neck Surgery
Job Description
- Develop pricing for all products and parts in the Specialty product group.
- Create sales collateral including Product Brochures, Ads, Practice Marketing Materials, Sales Videos, Web content, Competitive Sales aids etc.
- Establish and maintain ongoing relationships with Key Opinion Leaders (KOL) in the ENT / Head and Neck Surgery market
- Serve as product/market expert for worldwide marketing teams as related to technology, product positioning, competitive information and product performance.
- Provide guidance on the development and maintenance of packaging and labeling.
- Work with regional management to collect and assess the 'voice of the customer' perspective, competitive data and emerging technology trends in support of new product development, product enhancements and competitive positioning.
- Provide sales support to regional management by answering questions/resolving on-going product management issues.
Other general and specified duties may be assigned, consistent with the company's goals, objectives and interests.
Level of Supervision Required:
Minimal, supervision required. Goals and objectives will be defined together with Management and fulfillment reviewed on a quarterly basis.Requirements:
A. Education: BS in marketing, or industrial management. MBA preferred.
B. Experience: in product marketing in the medical device business, ENT experience a plus. Physical science exposure and understanding a plus.
C. Technical Job Skills: In-depth knowledge of the product marketing function. Experience in new product development. Process-oriented approach to manage long-term and short-term tasks. Excellent interpersonal skills; superb verbal and written communication skills required. Applicant should be proficient in Excel, Word, PowerPoint, and Microsoft Project.
D. Travel: 20% - 30%.
This job description in no way states or implies that these are the only duties to be performed by
the employee occupying this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties required by their supervisor.
****************************************************************
Contact:
Alan Hirshman
Senior Principal
IMS Management Consulting
(Cell) 480.295.6743
(Office) 480.664.1766
(email) ahirshman@us.
IMS Consulting - Commercial Effectiveness Practice
Full-Time Consultant Position
Organization
Operating in more than 100 countries, IMS Health is the world’s leading provider of market intelligence to the pharmaceutical and healthcare industries. IMS offers leading-edge business intelligence products and services that are integral to client’s day-to–day operations, including portfolio optimization capabilities; launch and brand management solutions; sales force effectiveness innovations; and managed care an over-the-counter offerings. IMS’s Global Consulting teams are the premier industry resource for answers and actionable insights that improve ROI and the delivery of quality healthcare worldwide.
In the Commercial Effectiveness practice our consultants work closely with clients to develop innovative go-to-market approaches. Our end-to-end perspective on integrated sales and marketing processes ensures a coordinated allocation of both field force investments and the marketing promotional mix. With a diverse mix of top pharmaceutical and biotech clients, consultants in our practice gain exposure to solving the most pressing issues facing pharmaceutical executives and as a result help shape a “healthier” future for us all. Within the CE practice you will find an atmosphere charged with a sense of purpose minus the traditional consulting firm barriers. Our practice is an intriguing community of people, a diverse group of talented individuals who work together to help our clients be more successful. You will be given every opportunity to grow with us and that growth will be based solely on your performance. The Commercial Effectiveness practice has more than 700 consultants worldwide with our primary office located in Blue Bell, PA.
At IMS Consulting you will experience:
- A rapid learning curve and solid grounding in aspects of the pharmaceutical and healthcare industries
- Focused training in strategic thinking, analysis, data-interpretation, presentation and working with clients
- Early responsibility for delivering product, company and market analyses that will shape recommendations to our global multinational pharmaceutical clients
- An entrepreneurial environment providing significant growth opportunities
- A dedicated development coach and mentor to advise you on career goals and personal objectives
- A supportive and friendly environment focused on client, business and individual success
We are currently looking for experienced individuals seeking a stimulating opportunity to join us as Consultants.
Qualifications
- A Bachelors degree in business, economics and life sciences-related majors are preferred and 2 – 6 years related work experience in the health care industry or an MBA degree and 0 – 3 years related work experience
- Proven track record of excellence
- Excellent collaboration, interpersonal and team-working skills
- Strong written and verbal communication skills; strong analytical and numerical problem solving skills
- Quantitative modeling skills and/or experience an advantage, but not required
- Highest ethical standards effective time management skills
Knowledge and understanding of the market placePosition description
Within the CE practice of IMS consulting, teams are typically comprised of 2 - 6 team members. Consultant’s assignments range in complexity from basic analysis and problem solving to assisting in the development of more complex solutions. Consultants are under minimal direct supervision, and given the following responsibilities:
- Assists Senior Consultants and Engagement Managers with the review and analysis of client requirements or problems
- May lead a small team of analysts to deliver client solutions
- Develops detailed documentation and specifications
- Performs quantitative or qualitative analyses that lead in the identification of client issues and development of specific solutions
- Designs, structures, and delivers presentation that are appropriate for the intended audience with some senior input
- Development of proposals to solve client issues with cost effective solutions
- Proactively develops a broad knowledge of consulting methodologies and the pharmaceutical market through delivery of consulting engagements and participation in formal / informal learning opportunities
Additional information
Location : Blue Bell, PA or West Coast , United States
__________________________________________________________________________
IMS Consulting - Commercial Effectiveness Practice
Engagement Manager
Responsibilities
In the Commercial Effectiveness practice our consultants work closely with clients to develop innovative go-to-market approaches. Our end-to-end perspective on integrated sales and marketing processes ensures a coordinated allocation of both field force investments and the marketing promotional mix. With a diverse mix of top pharmaceutical and biotech clients, analysts in our practice gain exposure to solving the most pressing issues facing pharmaceutical executives and as a result help shape a “healthier” future for us all. Within the CE practice you will find an atmosphere charged with a sense of purpose minus the traditional consulting firm barriers. Our practice is an intriguing community of people, a diverse group of talented individuals who work together to help our clients be more successful. You will be given every opportunity to grow with us and that growth will be based solely on your performance. The Commercial Effectiveness practice has more than 700 consultants worldwide with openings in CA and PA.
Position Purpose:
Manages multiple consulting projects of varying complexity and ensures on-time and on-budget delivery for clients in the pharmaceutical or related industries. Contributes to new business development and maintaining and strengthening client base.
Principal Accountabilities:
Manages project teams including both internal and external resources in the design, development and delivery of client solutions. Provides coaching and direction to Consultants and Senior Consultants across multiple projects at any given time. Leads teams to review and analyze client requirements or challenges and develops and costs associated proposals that ensure profitability and high client satisfaction with limited if any senior management input. Manages the process of proposal preparation and/or modifications including overall bid integrity. Develops project plan with timelines and deliverables and leads project to successful completion, on-time and on-budget, from start to finish with little senior management guidance. Recommends improvements and alternative solutions to resolve problems. Serves as key point of contact with client. Provides high level input to, and ensures the development of, client reports and presentations and delivers all or significant portions of findings to client. Develops and/or elevates new business opportunities through the identification of follow-on work and new leads. Provides follow-up with client after project deliverable have been completed to ensure client satisfaction. Proactively continues to strengthen subject matter expertise through on the job experience, participation in conferences and symposiums and other forums for professional knowledge sharing. Proactively mentors, coaches and shares subject matter expertise with others to elevate our capabilities to deliver world-class solutions for clients. Takes a leadership role in the completion of internal projects.
Minimum Education, Experience, & Specialized Knowledge Required:
Bachelor’s degree with 8-12 years of related experience including consulting and pharmaceutical and/or healthcare industry experience. Possesses demonstrated expertise in one or more practice areas. Demonstrates excellent project management skills and client influencing and relationship building skills
********************************************************************
At Novartis Institutes for BioMedical Research (NIBR), the global research organization of Novartis, we are committed to discovering innovative medicines to cure disease and improve human health. By hiring the best academic, biotech, and pharmaceutical trained scientists, we have fostered an atmosphere for drug discovery where innovation is rewarded. It is ultimately the talent of the individual that determines our success, while our state-of-the-art technologies and resources enable these ideas to be realized.
NIBR has sites in Cambridge, Massachusetts; Emeryville, CA; Basel, Switzerland; Horsham, UK; and Shanghai, China. Our Emeryville location focuses on early drug discovery efforts for the Oncology Disease Area and offers a variety of positions in Biology, Chemistry, and functions such as Technology, Patents, Research Sciences and other areas that support our scientific resources.
Senior Research Investigator I, Biological Therapeutics - Requisition Number: 59943BR
Lead cross-functional scientific teams focused on the discovery and pre-clinical development of antibodies and other types of biological drugs for oncology indications. Participate in project reviews, decision-making, and new technology development for the Biological Therapeutics platform at Novartis. Must have a PhD in Immunology, Oncology, or a related field with at least 8 years of postgraduate experience. Biotechnology/pharmaceutical industry experience is required, as are an in-depth knowledge of cancer-associated signaling pathways and/or models of cancer. Experience with transitioning biological therapeutics projects into the clinic preferred; strong background in Immunology a plus.
Scientist I, Biological Therapeutics - Requisition Number: 62510BR
Validate potential oncology therapeutic targets by conducting independent laboratory work, analyzing data and interpreting results. Qualified candidates will need a Bachelor's or Master's degree in Cell Biology, Immunology, Molecular Biology or a related field, with at least 8 years of biotechnology or pharmaceutical work experience and expertise in mammalian cell culture and protein analysis techniques, including western blotting, ELISA and flow cytometry; broad experience in transfection (siRNA and cDNA); and experience in developing and utilizing cell-based assays for analysis of proliferation, cytotoxicity and/or intracellular signaling. Experience in cancer-associated signaling pathways and/or models of cancer, experience with biological therapeutics, ADC, qPCR, and viral transduction are all desirable.
Scientific Associate II, Biological Therapeutics - Requisition Number: 62511BR
Conduct research supporting the validation of potential oncology therapeutic targets by participating in the design of experiments, analyzing data, and interpreting results. Qualified candidates will need a Bachelor's or Master's degree in Cell Biology, Immunology, Molecular Biology or a related field, with at least 4 years of biotechnology or pharmaceutical work experience and expertise in mammalian cell culture and protein analysis techniques, including western blotting, ELISA and flow cytometry; experience in transfection (siRNA and cDNA); and experience in developing and utilizing cell-based assays for analysis of proliferation, cytotoxicity and/or intracellular signaling. Experience in cancer-associated signaling pathways and/or models of cancer, experience with biological therapeutics, ADC, qPCR, and viral transduction are all desirable.
Research Investigator II, Translational Sciences/Histopathology, Requisition Number: 59938BR
This individual will be responsible for planning and supervising multiple research projects within an experimental pathology group. Duties will include the conception, implementation, and interpretation (including pathological assessment) of immuno-histochemistry and histology-based studies that will guide the development of new drugs to treat human cancers. Key areas of research will include investigating and evaluating target expression in normal and cancer tissues and development of assays for biomarkers and patient stratification. Candidates should have a PhD with a strong background in cancer histopathology, as well as experience in translational research.
Research Investigator I, Cancer Biology, Requisition Number: 62261BR
We are seeking a highly motivated research investigator with a strong background in oncology research and expertise in cell cycle and DNA damage repair responses. This candidate will influence the composition and quality of the global oncology early target portfolio by direct experimental contributions and by intellectual influence and impact through interactions working both locally and on globally organized target identification and validation teams and with other functional lines, including those devoted to cancer bioinformatics and to the understanding of development and cellular signaling pathways. To qualify, candidates must have a Ph.D. in Molecular Biology, Cell Biology, Genetics, or another relevant field, with at least three years of postgraduate experience; an in-depth knowledge of cancer-associated signaling pathways and/or models of cancer; an understanding of cancer genetics and the ability to effectively use bioinformatics resources; knowledge of techniques for the characterization of cancer-associated signaling pathways and functional responses in in vitro functional assays and in the generation of relevant models; and the ability to devise experimental strategies and execute them in a timely manner to produce goal-oriented results.
Research Investigator I/II, Metabolism and Pharmacokinetics, Requisition Number 60863BR
We are looking for a highly qualified Ph.D. level Pharmacokinetics scientist who will be responsible for the design, analysis, interpretation and reporting of pharmacokinetic and pharmacokinetic-pharmacodynamic studies and who will participate on multidisciplinary drug discovery teams to plan, conduct, and interpret in vitro and pre-clinical drug metabolism studies. The selected candidate will need a Ph.D. in Pharmacokinetics or a related field with 5-12 years of relevant industry experience and an in-depth understanding of all aspects of DMPK, with special emphasis on the application of pharmacokinetics in drug discovery. Additional qualifications include experience in the design and management of both routine and mechanistic animal PK studies, the ability to direct PK resources across the organization to drive drug discovery efforts, knowledge and experience with the design of experiments to define PK- PD relationships and competency using compartmental and non-compartmental analysis, and pharmacokinetic modeling and simulation expertise using predictive software. Experience working with CROs is desirable.
Research Investigator II, Structural Chemistry, Requisition No. 59934BR
This person will be an integral member of drug discovery teams, leading receptor-ligand interaction studies and working closely with the scientists in protein biochemistry, computational chemistry, medicinal chemistry, and protein crystallography to provide support for structure-based drug design. Responsibilities will include hands-on NMR data acquisition, processing, and analysis focused on assessing ligand-binding and analyzing the solution structures of proteins and protein:ligand complexes and helping to establish an in-house NMR lab consisting of a 600 MHz spectrometer with associated computing and robotics. Experience in NMR instrumentation, methods, and data interpretation as applied to ligand-based studies and a strong background in protein chemistry and/or biophysical characterization of protein:ligand interaction is required. Experience in protein biochemistry and fragment-based screening is desirable.
Research Investigator II, Biochemical Lead Discovery, Requisition No. 61427BR
We are seeking a multifaceted and driven individual with a strong scientific background and relevant expertise in the molecular discovery and characterization of small molecule inhibitors/activators of protein targets who will design, develop, and implement both biochemical and biophysical assays suitable for the identification and characterization of such compounds. These assays should elucidate the mechanism of compound action on the target and enable project teams to evaluate the compounds and develop structure-activity relationships as part of the overall hit-to-lead process. This person will also generate innovative proposals and drive the implementation of new technological approaches and capabilities, create and implement project plans, and coordinate workflow and logistics to meet project goals and milestones. Candidates will need a Ph.D. in Enzymology or a related field, with at least 6 years of relevant postgraduate industry experience and an in-depth knowledge of enzymology and biophysics. Experience with enzyme and biophysics assay development is essential and experience with multiple assay technologies, compound screening formats, laboratory instrumentation and automation, data analysis and management, and a sound knowledge of the drug discovery process is highly desirable.
Scientific Associate I/II, Protein Sciences, Requisition No. 62208BR
This person will perform routine molecular biology work, including different cloning strategies, PCR amplification, DNA isolation and manipulation, and sequence analysis; small and medium scale expression of recombinant protein in E. coli; standard protein analysis techniques (SDS-PAGE gels and Western Blots), and be familiar with performing ELISAs and other protein analytic methods. Candidates will need a Bachelors degree with at least 3-5 years of industry experience, including strong expertise in tissue culture, cloning, and other molecular biology techniques, as well as in recombinant protein expression in E. coli and insect cells and in the analysis of recombinant protein expression.
Research Investigator II, Protein Sciences, Requisition No. 62209BR
NIBR is seeking a highly motivated scientist to contribute to the pre-clinical development of targeted oncology therapeutics. This person will be responsible for leading a group of protein biochemists to support the advancement of antibody and small molecule Oncology projects from early discovery to early development. This is a hands-on bench position which includes some management and supervisory responsibilities. Specifically, this person will produce proteins for X-ray crystallography, high-throughput screening, and therapeutic antibody programs. In addition to a Ph.D. with at least 5-8 years of industry experience, candidates will need strong expertise in protein biochemistry and related technologies, as well as a demonstrated working knowledge of the pre-clinical drug discovery process
Sr. Business Analyst, Requisition No. 61861BR
As a member of the Emeryville Research IT (NITAS) team at Novartis Institutes for Biomedical Research (NIBR), this person will partner with scientists in discovery chemistry and biology research to provide technical and scientific applications and services. Specifically, he or she will collaborate with scientists to support existing applications and methods, and assess and identify new opportunities for data management and utilization to further drug discovery and development efforts and administer enterprise applications supporting these objectives, ensuring they are running efficiently and are highly available. Requires an MS/PhD in Chemistry/Biology with a minimum of 7 years related experience or BS in Chemistry/Biology with a minimum 10 years related experience, or equivalent, along with a working knowledge of discovery research informatics systems for chemistry and biology data management and analysis, such as ActivityBase, ELN, Spotfire and Pipeline Pilot, knowledge of the drug discovery process with practical laboratory experience, and familiarity with Oracle databases and SQL.
To apply for these positions, please visit , click on the Careers tab, select Job Search US, then select the link for Novartis Institutes for BioMedical Research (NIBR) in Emeryville, CA and click on the link for the job title.
Postdoctoral Fellowships
NIBR Postdoctoral Fellowships provide talented scientists with the unique opportunity to conduct innovative, inter-disciplinary research. Fellows have a primary mentor at NIBR, may have an academic mentor, and develop their projects in consultation with the mentor(s). In the US, positions are available in Emeryville, CA, (near San Francisco); Cambridge, MA; and East Hanover, NJ; and internationally, in Shanghai, China; Basel, Switzerland; and Horsham, UK.
For more information and to apply, please visit: .
************************************************************************
Jobs That Crossed My Desk Through Feb. 21, 2010
********************************************************************
FOR FULL DESCRIPTIONS CONTACT:
Jarboe & Associates janetjarboe@ 970-686-5899 (office) 970-689-2962 (cell)
Clinical Pharmacokineticist - title to be determined - up to VP - West janetjarboe@
* Masters degree or Ph.D. in Clinical Pharmacology, or Pharmacokinetics, with at least 10 years relevant experience,
* The candidate should possess significant knowledge/understanding of Pharmacokinetics, PK/PD correlations, and pharmacology in general
* Responsibility for PK &PD sections of NDA/MAA filing
* Pop PK modeling and analysis using WinNonlin /NONMEM is desirable
* Able to demonstrate proven leadership capabilities and must possess strong communication skills, both verbal as well as written
* Candidates must have a sense of urgency and desire to get things done effectively and efficiently
______________________________________________________________________________________
Sr. Scientist/Principal Scientist - Clinical Pharmacology NE janetjarboe@
Ph.D. in Pharmacokinetics and Pharmacodynamics
3-7 years of postdoctoral and industrial experience
* PK/PD models, PK/PD software skills (WinNonlin, Kinetica, Clinical Trial Simulator and NONMEM)
* Good computer and software skills (MS Office, Sigma Plot, statistical programs).
* Good knowledge of GCP/ICH guidelines and FDA regulations and guidance * Good understanding of the drug development process
* Excellent organizational and interpersonal skills * Excellent verbal and written skills
* Excellent presentation skills * Multidisciplinary collaborations
________________________________________________________________________________________
Modeling & Simulation Scientist - Clinical Pharmacology NE janetjarboe@
PhD in pharmacokinetics/pharmacodynamics or related discipline, MD or PharmD
Minimum of 2 years experience in the conduct of M&S projects, preferably supporting clinical trials
*Knowledge and proficiency with the theory and application of PK/PD, compartmental, and noncompartmental analyses and fundamentals of pharmacostatistical modeling
*Hands-on experience in M&S software including NONMEM, WinNonlin, Trial simulator (TS), S-Plus, and SAS
*Knowledge of the role of PK/PD analyses in drug development and FDA/ICH requirements for drug registration
*Excellent verbal, written, and presentation skills *Multidisciplinary collaborations
________________________________________________________________________________________
Sr Scientist III, Biodisposition janetjarboe@ SW
- M.S. in an appropriate discipline (e.g. Pharmacokinetics, Pharmacology, Biochemistry, Chemistry) with 9-10 years industry experience.
- Ph.D. in an appropriate discipline (e.g. Pharmacokinetics, Pharmacology, Biochemistry, Chemistry) with usually 6 years industry experience.
- Demonstrated expertise in the design and conduct of pharmacokinetic and drug disposition studies.
_____________________________________________________________________________________________
Manager, Biodisposition SW janetjarboe@
- Advanced degree (Ph.D.) in an appropriate discipline (e.g. Pharmacokinetics, Pharmacology, Biochemistry, Chemistry) with 8-17 years industry experience.
- Demonstrated expertise in the design and conduct of pharmacokinetic and toxicokinetic studies and the analysis and interpretation their study data.
- Superior writing skills are a critical qualification. Experience in the preparation of global regulatory submission documents highly desired.
- Demonstrated leadership, management and interpersonal skills and the ability to communicate results to internal and external audiences.
____________________________________________________________________________________________
Building world class Clinical Pharmacology group for stable, successful, large company-SW janetjarboe@ Experimental Medicine seeking M.D. and/or PhD, can consider those with all academia experience/ industry experience.
________________________________________________________________________________________________
Assistant Director, Medical Writing MW janetjarboe@
BA/BS degree or equivalent; 10+ years relevant experience.
Preferred: PhD/Pharm D or MS/MA/MPH with at least 2 years managing regulated documents in pharmaceutical industry.
Regulated Document Knowledge: In depth knowledge of FDA regulations and guidance and ICH guidelines for all document types produced by Medical Writing so as to be able to ensure that standards and formats used locally structure documents correctly.
Standards and Formats: Maintains established processes; able to assist in the development of local templates; able to modify the presentation of content within established templates.
Interactions outside Medical Writing: Able to act as the Medical Writing representative on project team (extended team) as a substitute for more senior staff on an intermittent basis for a particular therapeutic area.
Resources Management / Staff: Able to assist more senior staff in training activities for senior manager and below.
________________________________________________________________________________________________
Sr. Manager/Asst. Director, Biostatistics - MW janetjarboe@
• At least 6 years of experience in the pharmaceutical industry or related area with a Ph.D. or equivalent degree in Statistics, Biostatistics or related field or at least 8 years of experience in the pharmaceutical industry or related area with an M.S. A minimum of 5 years oncology experience in industry is an absolute must. Level of position will be commensurate with experience of selected candidate.
• Experience designing and analyzing clinical trials as the main statistician.
• Experience interacting with regulatory agencies (e.g. end of Phase 2, pre-NDA, or advisory committee meetings with the FDA, Canadian Health meetings, or correspondence with EMEA meetings) preferred.
• Excellent oral and written communication skills.
• Excellent interpersonal skills to effectively work in cross-functional project teams.
• Knowledgeable and competent in the use of project management skills.
• Ability to work independently and on multiple projects and studies at one time.
• Good knowledge and skills of SAS and other statistical software.
___________________________________________________________________________________________________
Senior Staff Scientist/Associate Director Preclinical Development NE janetjarboe@
This position requires an advanced degree in Biology, Immunology or a related field and at least 8 years of laboratory experience specifically involved in the development and validation of immunogenicity assays. The individual will direct the development and validation of immunogenicity assays for the detection of anti-drug antibodies and the interpretation of results from preclinical and clinical studies. They will be responsible for guiding all immunogenicity programs, establishing deliverables and communicating program objectives to project teams. They will also be responsible for writing validation protocols, reports, SOPs and sections for both IND5 and BLAs. The successful candidate must possess excellent leadership, organizational and communication skills. The ability to effectively interact with colleagues in a team environment, and the ability to independently plan, supervise and direct projects to completion are essential. Significant experience developing and validating immunogenicity assays in a GLP environment is required.
____________________________________________________________________________________________________
Senior Scientist / Scientist, Cell Line Development WEST janetjarboe@
The successful candidate will have a PhD in biotechnology, cell biology, biochemistry or related discipline with minimum 5 years of relevant industry experience. Other required experience includes expertise in a broad range of molecular and cellular techniques surrounding aspects of cell culture, vector development and expression technologies, cell line development, and cell banking. Experience with management of research associates and demonstrated leadership is preferred. Excellent verbal and communication skills, as well as the ability to work in a team environment are essential.
______________________________________________________________________________________________________
Formulation Development Scientist - WEST janetjarboe@
• Ph.D. in a scientific discipline (Biochemistry, Chemical Engineering, or Biochemical Engineering) with 5+ years of relevant experience in the pharmaceutical /biotechnology industries.
• Experience in the pharmaceutical industry is preferred in formulation development or related biochemistry related areas of development (e.g. purification, stability, analytical).
• Experience working with monoclonal antibodies and exposure to early phase formulation development activities
• Experience with IV formulations as well as formulation development for poorly soluble compounds would be desirable.
• Proven experience managing the scale-up and manufacturing of parenteral dosage forms
• Proven ability to apply the principles of the basic sciences, such as physical and organic chemistry, thermodynamics, and materials science, to pre-formulation and formulation development, using a rational, scientific approach.
• Supervisory experience preferred.
• Must be highly motivated, have excellent organizational and communication skills, and must be able to work independently and as part of a multi-disciplinary team.
______________________________________________________________________________________________________________
Target Discovery - WEST janetjarboe@
The successful candidate will have a PhD in molecular biology, biotechnology, biochemistry or related discipline with minimum 5 years of relevant industry experience. Other required experience includes expertise in a broad range of molecular and cellular techniques surrounding aspects of microarray-based discovery, biomarker identification and target selection for product development. Experience with management of research associates and demonstrated leadership is preferred. Excellent verbal and communication skills, as well as the ability to work in a dynamic team environment are essential.
The successful candidate will have a PhD in molecular biology, biotechnology, biochemistry or related discipline with minimum 5 years of relevant industry experience. Other required experience includes expertise in a broad range of molecular and cellular techniques surrounding aspects of microarray-based discovery, biomarker identification and target selection for product development. Experience with management of research associates and demonstrated leadership is preferred. Excellent verbal and communication skills, as well as the ability to work in a dynamic team environment are essential.
___________________________________________________________________________________________________________
Research Associate - WEST janetjarboe@
Master’s of Science in Medicine, Pathology, Pharmaceutical or Biological Sciences or
foreign equivalent plus two (2) years of experience in the job offered or related position.
Research Associate / Senior Associate, Target Function - MAb Assays - WEST janetjarboe@
The position requires a BS or MS in Biology or a related field with a minimum 3 years of practical experience in a research laboratory in the required activities. Industry experience and previous work in biochemical, immunological, cell culture and cell-based techniques are essential. Excellent verbal and communication skills and the ability to work both independently and in a team environment are required.
Senior Research Associate, In vivo Validation - WEST janetjarboe@
The ideal candidate should have a MS in biological sciences with a minimum of 5 years experience in biological research, preferably in an industry setting. Previous experience in handling research rodents, especially immunodeficient mice, is absolutely required. Experiences in pre-clinical validation of cancer therapeutics using xenograft models, performing microsurgical procedures in rodents, xenograft tumor characterization and mammalian cell culture are highly desired. We are seeking a flexible, enthusiastic individual with good organizational and communication skills and the desire to work in a dynamic team environment.
Research Associate, Target Discovery - WEST janetjarboe@
The ideal candidate will have a M.S. or B.S. in Molecular Biology or related field, with preferably a minimum of three (3) years of relevant experience in industry. Experience in microarray systems, data analysis, RNA isolation, and real-time PCR is required. Excellent verbal and communication skills, as well as the ability to work in a team environment are essential.
Research Associate, Cell Line Development- WEST janetjarboe@
The ideal candidate will have a M.S. or B.S. in Molecular Biology or related field, with preferably a minimum of three (3) years of relevant experience in industry. Experience in antibody expression systems, production cell line generation, and antibody characterization is required. Excellent verbal and communication skills, as well as the ability to work in a team environment are essential.
Research Associate, Translational Research - WEST janetjarboe@
Candidate consideration requires a BS/MS in molecular and cellular biology or similar field with a minimum of 3 years of relevant laboratory experience. Industrial experience in Oncology drug discovery is preferred. Successful candidates will have strong written and oral communication skills and be self-motivated.
Medical Director Anti-infective – title / level to be determined - WEST janetjarboe@
This position reports directly into the Chief Medical Officer (CMO) and manages the integrated development strategy and the resultant tactical clinical plan and study designs to support the global development of and establish the conditions essential for determining the safety, efficacy, medical usefulness, and marketability of multiple compounds.
* MD or internationally recognized equivalent plus 5 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned).
Preferred:
* Infectious disease (antibacterial) specialty, though not required
* Phase 1 - Phase 4/ biomedical pharmaceutical clinical research experience
TRAVEL REQUIREMENTS:
* Able to fly to various meetings at investigator, vendor or regulatory agency sites.
* Some international travel will be required.
Associate Medical Director/Medical Director, Medical Affairs - MW janetjarboe@
M.D. degree, Board Certified or Board Eligible in Designated Specialty (preferred) with subject matter expertise in dermatology or Immunology
Three years clinical or clinical research experience preferred
One year experience in the pharmaceutical industry preferred
Excellent communication and presentation skills, strong interpersonal skills.
Strong clinical research/medical affairs background, and excellent problem solving abilities.
Demonstrate abilities to work effectively in a team environment.
Ability to interpret and evaluate clinical data.
Leadership skills and ability to effectively manage projects and timelines.
Knowledge of pharmaceutical clinical development and ability to effectively apply technical principles, theories, and concepts to clinical drug development.
Knowledge of FDA, other regulatory agency and professional requirements, regulations and guidances
Able to work independently on all aspects of assigned projects
Excellent organizational skills
Medical Director, Medical Sciences - MW janetjarboe@
M.D. degree, Board Certified or Board Eligible in Designated Specialty
Minimum three years clinical experience
Minimum two years laboratory or clinical research experience and five years experience in the pharmaceutical industry or equivalent academic experience.
Strong working-knowledge of regulatory procedures and guidelines (preferably US)
Effective team player in a matrixed R&D environment
Able to work independently on all aspects of assigned projects
Excellent presentation and writing skills
Excellent organizational skills
Senior Medical Director, Pharmacovigilance, Oncology - MW janetjarboe@
MD degree, Pharmaceutical Industry experience in Pharmacovigilance and drug safety for at least five years.
Experience with oncology highly preferred. Team working, analytical skills, and flexibility are essential for this position.
Associate Medical Director/Medical Director - MW janetjarboe@
-M.D. degree, preferably with training in internal medicine, family practice is helpful.
-Minimum two to five years pharmaceutical development experience in the pharmaceutical industry or equivalent academic experience.
-Strong working-knowledge of regulatory procedures and guidelines (preferably US)
-The candidate must demonstrate an ability to manage multiple studies, and to work independently on assigned projects.
-Effective team player in a matrixed R&D environment
-Excellent presentation and writing skills
-Excellent organizational skills
Medical Affairs Director, Latin America (very high level position, must reside in U.S.) - MW janetjarboe@
- A minimum of five (5) years in a Medical Director Role but someone with a total of 20 years experience would not be too senior.
- Medical Degree; must have a License of Medical Doctor & Board certification in at least one specialty with basic medical science and research experience.
- Strong people management skills
- Basic marketing skills as well as understanding business practices and technical terms in business.
- Business acumen, a bottom-line orientation, strong management and leadership skills.
- Must have proficiency in both Spanish and English (Portuguese a plus) in order to interact with the other team clinicians at the corporate headquarters in the US, as well worldwide.
- Present, discuss, negotiate & persuade the global team in English
- Self motivated, both strategic and tactical in his/her thought process and capable of becoming rapidly engaged in the company’s business
- High degree of self-direction, with the ability to quickly make decisions and accept responsibility for outcomes
Senior Medical Director, Pharmacovigilance, Infectious Diseases - MW janetjarboe@
MD degree, Pharmaceutical Industry experience in Pharmacovigilance and drug safety for at least five years.
Team working, analytical skills, and flexibility are essential for this position.
*********************************************************************
Ralph Rawat
Asst. VP-Strategic Talent Acquisition
Sterling-Hoffman Life Sciences
408-484-9077ext 159
ralph@
We were recently engaged by one of our client in a search to find a Senior Formulations Scientist for their Colorado facility, I’m hoping someone in your network can take advantage of this opportunity.
The company develops and manufactures pharmaceutical/nutritional products and has grown their revenues to nearly $60 million over the past 80 years. They’re looking for someone with a minimum of 7 years experience with formulation development, scale-up and manufacturing, and has worked on NDAs or ANDAs.
They are happy to provide relocation help for someone outside of the area. Any ideas would be really appreciated, and please don't hesitate to pass my information along if you think it makes sense.
*****************************************************************************Contact:
Please apply online, or email Lindsey Summers at lsummers@.
PharmAscent, A Division of The Ascent Services Group specializes in nationwide direct hire and contract placement for the Pharmaceutical and Biotechnology industry.
Manager, Medical Writing – Nutley, NJ
Responsibilities:
• Facilitate performance goals for filing regulatory submissions by coordinating all activities involved in planning and preparing regulatory documentation
• Coordinates documentation activities of all contributors to dossier
• Implements and manages documentation processes
• Manages external dossier documentation support
• Coordinates all documentation-related training=
• Ensures effective documentation-related planning and development and integration of key regulatory messages
• Manages the document review process
• Drives key documentation activities.
• Ensures appropriate consistency between regulatory documents and marketing publications
Requirements:
• Advanced degree, preferably in natural sciences, extensive relevant experience in the pharmaceutical industry REQUIRED
• 5+ years experience in drug development in a global company
• Experience with preparation and submission of regulatory dossiers in US and Europe , preferably having participated in the preparation of high-level summary documents in at least two different submissions.
• Demonstrated ability to lead and communicate effectively at all levels in a complex multi-functional environment.
****************************************************************************
Contact:
Jessica Warchal
Recruitment Sourcing Specialist · i3
1001 Winstead Drive · Suite 200 · Cary, NC 27513
Direct: (919) 678 4632 · Main: (800) 200 1245ext. 84632 · Fax: (973) 241 9623
jessica.warchal@
Director, Global Medical Writing and Scientific Communications, Location not Specified
i3 Statprobe focuses exclusively on providing the pharmaceutical and biotechnology industries with comprehensive, integrated data service solutions that include data capture, summary, analysis, and reporting for clinical trials across all phases of research. The company demonstrates leadership and innovation by leveraging world-class process design and six-sigma quality, affording clients the ability to maximize efficiencies and exceed customer expectations.
As a UnitedHealth Group company, i3 Statprobe is part of a worldwide health care service organization that uses innovation, integrity and commitment to prepare for the future - and you can prepare for yours with us. It's a rare combination for success that only a career with i3 Statprobe can provide.
We are currently seeking a Director, Global Medical Writing and Scientific Communications, to be based in Ann Arbor, MI; Cary, NC; San Diego, CA; Basking Ridge, NJ; Cincinnati, OH; Lexington, KY; or Austin, TX. The ideal candidate could be home based.
The Director, Global Medical Writing & Scientific Communications provides leadership and support for the development of clinical documents and scientific publications, providing high-level input in ongoing departmental and project-based strategic planning.
Responsibilities:
• Develops, maintains, supervises and evaluates a global department of technical / regulatory medical and scientific writers
• Actively supports ongoing business development efforts related to medical and scientific writing and report processing services
• Conducts strategic planning
• Manages, coaches and guides development of direct reports and effectively delegates, as required
• Participates in presentations to clients for general capabilities as well as specific project proposals
• Provides scientific direction to internal and account teams and to clients and authors, as needed
• Ensures quality standards of writing among staff and contractors are met and are periodically reviewed, as needed
• Participates in the recruitment of employees and contractors
• Provides input to maintain standards, work ethics, processes and procedures necessary to run a cost efficient department
• Prepares and / or reviews global SOPs, as necessary
• Monitors literature, including therapeutic, competitive and technical
• Identifies training and development programs for self and staff
• Maintains professional knowledge by affiliating with professional and technical organizations, and participating in applicable continuing education programs, conferences, seminars and workshops
• Complete administrative tasks, as appropriate
Qualifications:
• Bachelor's degree required; MS, MPH, PharmD, PhD or other advanced life sciences degree is preferred
• Extensive experience in the preparation of clinical documents for regulatory submission, including clinical protocols, study reports and integrated summaries
• Senior-level management experience in the area of medical writing, publications or communications
• Strong knowledge of US and international pharmaceutical regulations, requirements and guidance documents associated with document preparation and submission
• Knowledge of and experience with CTD content templates, electronic document management systems and information technology
• Participation in the filing of CTDs, MAAs and NDAs
• Good overall knowledge of the clinical trial process and GCP regulatory requirements for the conduct of clinical development programs
• Proven ability to think creatively, meet deadlines and manage multiple tasks simultaneously
• Ability and willingness to travel (up to 30%)
************************************************************************
Contact:
Please apply online, or email Lindsey Summers at lsummers@.
PharmAscent, A Division of The Ascent Services Group specializes in nationwide direct hire and contract placement for the Pharmaceutical and Biotechnology industry.
Medical Writer – Nutley, NJ
Permanent, on-site position
Responsibilities:
• Produces clinical documents (e.g., study reports, CTD clinical summaries and Investigator Brochures) with supervision as necessary.
• Provides input into the production of Data Reporting and Analysis Manuals. Resolves issues, errors, or inconsistencies in report/summary data with pertinent members of the team.
• Plans and creates timelines for the production of assigned clinical documents.
• Acquires knowledge of regulatory guidelines, procedures and best practices and applies these to assigned clinical documents.
• Provides feedback on existing guidelines.
• Reviews clinical documents with supervision as necessary. Reviews documents for organization, clarity, scientific standards and consistency between textual presentations and tabular or graphical displays.
• Serves as a member of Study Management Teams, Clinical Teams, and RAFTs with supervision, if necessary.
• With increasing experience, takes on mentoring of less experienced group members in specified areas.
Requirements:
• Ph.D. in a relevant scientific discipline or MS with documentation experience (or equivalent).
• Demonstrated clear, high-quality writing style in the English language.
• Ability to independently analyze and synthesize data from abroad range of scientific disciplines.
*****************************************************************************Contact:
Please apply online, or email Lindsey Summers at lsummers@.
PharmAscent, A Division of The Ascent Services Group specializes in nationwide direct hire and contract placement for the Pharmaceutical and Biotechnology industry.
CMC Biologics Writer – NJ
Permanent, on-site position
Responsibilities:
• Responsible for generating the technical content for CMC documentation required for investigational new drug applications, amendments, marketing applications and supplements/amendments.
• Prepares technical sections for regulatory filings
• Coordinate completion of CMC templates with Regulatory Affairs CMC
• Summarize technical reports and documents
• Working knowledge of project plans for those projects to ensure CMC sections are delivered on time
• Serve as a member of multi-disciplinary teams organized to ensure project timelines are met and clinical and commercial supplies are available
• Assist with preparation of an optimized work flow for document creation, review and completion.
Requirements:
• 7+ years industry experience with at least 1 year of authoring or handling regulatory documentation
• Knowledge of US regulatory requirements with global regulatory experience
• Technical knowledge of biopharmaceutical manufacturing process preferably in antibody manufacturing with expertise in a technical discipline a plus
• BS//BA Biochemistry, Chemistry, Microbiology, Pharmaceutics, Chemical Engineering, advanced degree a plus
• Knowledge of cGMPs
*****************************************************************************
Contact:
If you're interested or have any questions please don't hesitate to call or email:
Matt Soloperto | Consultant
Life Science Division
The Bowdoin Group |
msoloperto@
in/mattsoloperto
Principal Medical Writer – Cambridge, MA
We are seeking a talented, highly motivated team player who will be responsible for producing documents for regulatory submission. This is an in-house, permanent role.
Responsibilities:
• Produce and/or update Investigator Brochures, clinical protocols, clinical study reports, safety narratives, and correspondence with regulatory agencies in accordance with predefined timelines.
• From listings, tables, and other sources of clinical information, produce cohesive, meaningful analyses and summaries in written and graphic formats.
Coordinate production of INDs, BLAs, or NDAs in cooperation with Regulatory Affairs and
• other team members.
• Review draft documents and draft statistical output for accuracy and consistency.
• Write and edit documents in accordance with established style guidelines.
Qualifications of the Ideal Candidate:
• B.S., M. S., or Ph. D. in a relevant field. At least 3 years of regulatory medical writing experience and 2 years of pertinent experience in the biopharmaceuticals industry. Experience with producing INDs, BLAs, or NDAs in CTD format is preferred.
• Excellent writing and interpretive skills. Qualified candidates will be asked to submit a writing sample before being interviewed.
• Expert working knowledge of ICH E2 and E6 plus CFR 312 and 314. Knowledge of Canadian and/or EU regulatory requirements is preferred.
• General knowledge of applied clinical medicine and laboratory interpretation. Experience with large-molecule drug development is preferred.
• Advanced knowledge of Microsoft Word, Excel, and PowerPoint. Familiarity with other graphics software is preferred.
• Experience with an electronic document control and management system.
****************************************************************
Contact:
Robin Reyes
Staffing Manager
Sai People Solutions, Inc.
"Celebrating 25 Years of Consultant Satisfaction"
Toll-Free: 866-313-6849 x 124
Phone: 281-358-9411 x 124
EFax: 1-(773)-303-1370
Email: rreyes@
Web:
Senior Medical Writer, Contract – San Carlos, CA
We have an urgent requirement for the following contract medical writing position, located in San Carlos, CA, in the San Francisco Bay Area. The contract is for 3+ months.
Responsibilities:
• Responsible for researching, writing and editing clinical reports, summarizing data from clinical studies for submissions to the FDA and for publication and/or presentation.
• Will also assist in the development of formats and guidelines for clinical documentation.
• May support CRAs and MDs in clinical protocol development.
• Remains informed of the latest professional, technological, and regulatory developments in medical writing, as well as therapeutic areas.
Essential Duties and Responsibilities:
• Assists with the management and execution of all clinical writing activities outlined in the Project Clinical Development Plans (CDPs).
• Assists with the development and ongoing management of Departmental Guidelines management system, writing style guide, and departmental templates, such as protocols, investigator's brochures, final clinical study reports, and IND sections.
• Provides and manages internal and external writing activities.
• May supervise the activities of junior medical writing staff.
Minimum Qualifications:
• A minimum of 8 years medical writing experience is required.
• A minimum of 5 years experience in a pharmaceutical, biotech, or CRO medical writing position is required.
• An ability to create effective presentations from raw data is essential.
• An ability to interpret statistical and clinical data is essential.
• Must have an ability to work well with others in high-pressure situations.
• Must have demonstrated problem solving abilities.
• Strong organizational skills are required.
• Strong written and verbal communication skills are required.
• An understanding of clinical research, biostatistics, and regulatory affairs is required.
• Must have experience writing clinical protocols, clinical study reports, IND sections, abstracts, and manuscripts.
• Good computer skills are required. Working knowledge of MS word, Excel, Power point, Lotus notes is a plus.
Education:
A minimum of a Bachelors/Masters degree in a scientific discipline is required. Equivalent experience may be accepted.
**********************************************************
Contact:
Jenny Nichols
Senior Recruiter
ClinFinder
Tel: 858-412-4230
Email: jmg@
Medical writer – Winston-Salem, NC
A small, growing, biopharma in Winston-Salem, NC, is looking for a Medical Writer. This is a permanent, full-time, in-house position and the incumbent will be the sole writer. Position is in the Clinical Development & Regulatory Affairs Department. Must have a minimum of a Bachelors degree and Five years' industry experience writing regulatory and clinical documents. CNS experience a HUGE plus.
Salary into the $90s plus bonus and relocation assistance. Reports to the Sr. Director, Biometrics.
Job Description:
The Medical Writer is expected to deliver high-quality regulatory documents that meet ICH standards, project timelines, and regulatory specifications. The responsibilities of the Medical
Writer includes management and preparation of a variety of clinical documents, including protocols, clinical study reports, narratives, worldwide regulatory submissions, and investigator brochures for clinical trials.
• Work with key interface partners (e.g. Project Management, Statistics, Programming, Chemical Manufacturing, Regulatory Affairs) to facilitate completion of complex documents, including protocols, clinical study reports, investigator brochures, and other clinical and regulatory documents.
• Participate ad-hoc on relevant project teams and task forces, and provide guidance to clinical, safety, nonclinical, Quality, and CMC functions on a wide range of issues related to document preparation and production. These include US and international regulatory guidance and requirements for content and format, organizational requirements (style, electronic integrity, and process), and project- or therapeutic area-specific guidance related to content and organization of specific documents.
• Use project management skills to create timelines, track, review, and ensure timely completion of high quality regulatory and clinical documents.
• Participate in planning of analysis and data presentation to be used in study reports or summary documents.
• Review data to determine the appropriate tabular and textual formats, and the clarity, logic and order of presentation.
• Develop and update specifications, format production elements, and track regulatory documents and artwork used in regulatory documents.
• Develop and update Targacept editorial style standards, provides guidance to project teams regarding regulatory submissions, and develop and update general writing guidelines.
• Document, review, update, and maintain Standard Operating Procedures (SOPs) for all medical writing activities in accordance to good Clinical Practices and Federal Regulatory requirements.
• Participate, as needed, in the creation of SOP templates for all functional areas and with QA staff.
• Participate in Clinical Operations meetings and training initiatives, project team meetings, and maintain relationships with other internal departments as necessary.
• Other duties as assigned.
*************************************************************************
Joy Bridges
Medical Device Recruiter
LEGACY MEDSearch
Emerging Medical Technology Recruitment
Phone: 407-898-4440 ext. 104
Fax: 407-898-4494
Director of Marketing - Medical Devices (Job ID: 217 DCM)
As Director of Marketing you will use your strong Business Development and Product Marketing experience, to lead the tactical and strategic management responsibilities for a complex medical/surgical product line. The ideal candidate will have demonstrated success in need identification and specification and will have led product introductions, developed and executed marketing plans, identified competitive threats, and cultivated key internal and external physician relationships. You should be adept in both presenting and message in a persuasive selling style and be a "team builder" as it relates to collaboration with an aggressive and high caliber direct Sales force. This is an "upstream" marketing role requiring a calculated and analytical risk taker who has knowledge of heighten DOJ scrutiny relative to clinical and regulatory issues - but also someone who can create appropriate strategies to drive revenue growth and complying with relevant regulations. The position also requires a goal-driven, confident self-starter with the flexibility and capabilities to think strategically, execute on timelines to achieve key business goals and influence a wide array of key partners.
[pic]
Position Responsibilities
• Approximately 30% of your time will be directed at working with Surgeon / Physician / Clinicians where you will manage need identification in your upstream marketing capacity. Working with your colleagues in R&D, Product Development, Sales, and KOLs, you will develop marketing plans and activities for the product line to establish, enhance or distinguish product placement within the competitive arena.
• Approximately 30% of your time will involve capitalizing on your prior engineering, clinical, or scientific education and experience as you collaborate in sourcing, negotiating, and executing key strategic business development deals to drive both organic and inorganic growth through acquisition or strategic development.
• Approximately 30% of your time will be spent in program management on current and new products and enhancements, including product roadmaps, PLC management and then effectively communicating product strategy to the organization with a strong emphasis on sales and external constituents.
• Represent the company at tradeshows, academic, and specialty meetings where you will become an expert on both the technical and clinical aspects of the product as you lead advisory panels and user groups.
• Develop responsible promotion strategies to capture increased market share and to grow momentum and continued high morale of the sales force, as well as develop and lead sales training activities.
• You will lead the development of luminary publications, clinical white papers, sponsored studies and work with leading researchers and universities and develop post marketing protocols to support clinical and marketing efforts.
Education Requirements:
• Bachelor’s degree ++ in science or engineering or related discipline and 5+ years of progressively increasing experience successfully managing various facets of marketing and business development programs.
• MBA and/or Clinical experience or MD is also highly desired.
Position Requirements:
• 5+ years marketing experience in medical device industry with strong preference for cardiovascular device experience.
• Experience in leading new product development efforts form both a technical / specification standpoint and a branding / messaging standpoint.
• Ability - and desire - to work in an extremely entrepreneurial environment with moderate supervision.
• Demonstrated process development and implementation skills tempered with the flexibility to be results oriented in a fast-paced environment.
• Experience with the marketing of complex, medical capital equipment is desirable.
• Specific clinical, vascular, electrophysiology or interventional cardiology marketing experience is a strong plus.
• Strong written and verbal skills - you should be a persuasive, engaging, and clinical credible presenter in working with both physicians and customer-facing colleagues.
********************************************************************
Maura Koller, CSAM, Practice Leader
MRIGlobalBioMed Announcing the new name for the Medical Device and Biotech Group of MRI Baltimore-Timonium
MKoller@
Manager of System & Test Engineering (Ideally the right candidate for each position will have a product development background). This is a confidential search with one of our key clients. (Class III Medical Devices/Orthopedic Implants)
Position Description:
The successful candidate for this position will lead the Systems Engineering and Test Engineering functions in a matrix development organization for the Platform Development group for this company. The Systems Engineering function includes high-level design of company’s robotics product line and associated systems, requirements development, project leadership and hazard analysis. The Test Engineering function includes the development of test protocols, procedures, and tools to test conformance to requirements, as well as planning and executing the verification and validation testing.
Responsibilities
• Manage the Systems Engineering function, including Verification and Validation Testing at the systems level
• Work with Program Managers and internal customers to negotiate requirements and schedules to align with resource constraints
• Lead the establishment of Best Practices for Systems Engineering, including requirements development, workflow analysis, project scheduling, hazard analysis (FMEA / FTA), system level design, testing processes, etc.
• Create and maintain project plans, budget reports, and other documents necessary to track and communicate projects and department status
• Coordinate and participate in the establishment of budget, priorities, and resource requirements for development projects
• Supervision, hiring, and firing responsibility for personnel on the team. Human Resource manager and supervisor shall be notified and consulted on decisions before any related action is taken
• Uphold the quality policies of the company
• Reports to Director of Development
Requirements
· BS in Mechanical, Electrical or Biomedical Engineering and 7 years minimum experience in medical device product development or MS in Mechanical, Electrical or Biomedical Engineering and 5 years min. experience in medical device product development
· Minimum of 2 years experience supervising engineers and technicians in system engineering
· Demonstrated knowledge of electro-mechanical systems including cutting systems, control systems, motors, and actuators
· Demonstrated knowledge of requirements development and translating customer requirements into detailed system and component level requirements
· Experience with test protocol development and test report generation in a medical device environment
· Demonstrated knowledge of design control methods to support 21 CFR 820 / ISO 13485 regulations
*****************************************************************************
A Client is looking for a Senior level Process Development Director (this is a full time position). If you know of anyone interested, please have them contact me at Julie@.
Thanks! Julie Bukar Managing Director; JGB BioPharma Consulting Inc.
Director/Senior Director Process Development (San Francisco Bay area)
DESCRIPTION:
The successful candidate will lead the development of mammalian cell culture and microbial fermentation processes for the production of human monoclonal antibodies and recombinant human proteins suitable for GMP manufacturing of therapeutic antibodies as well as the development of downstream purification processes for these products. Working with others in the organization, this person will also play an important role in the successful technology transfer to and scale-up at large-scale GMP manufacturing sites.
EXPERIENCE AND QUALIFICATIONS:
Hands-on experience with mammalian cell culture process development and microbial fermentation process development including fed-batch bioreactor process parameters, media optimization and harvest recovery operations, and typical unit operations used for the purification of therapeutic proteins from cell culture/fermentation media.
Ph.D. in Life Sciences or advanced degree in Engineering or equivalent; at least ten years combined industrial experience in cell culture process development, fermentation process development, and protein purification; management experience highly desirable. The successful candidate will be organized, self-motivated, and able to work independently and as part of a team. Excellent written and verbal communication skills are required. Some weekend work and travel for process transfer will be required
*****************************************************************************
Interested candidates can forward their resume to rajinder.bhatia@
Research Associate I/II
Wave 80 Biosciences is a fast-growing, early-stage diagnostics company developing innovative molecular assay methods and next-generation clinical laboratory testing systems. Wave 80 is seeking one or more highly motivated individuals to join its R&D group in the position of Research Associate I/II located in San Francisco's Mission Bay district.
Responsibilities will include:
• Standard molecular biology methods for DNA/RNA analysis and assay development, including hybridization, amplification, labeling, and detection in microfluidic and conventional laboratory equipment: ELISA, FACS, etc. Perform other lab duties such as preparing stock solutions, assisting with lab inventory, and lab maintenance.
• Perform moderately complex lab procedures involving non-infectious human tissue samples, including microscopic analysis of cell culture.
• Quantitative data analysis using scientific software applications and tools. Troubleshoot assays and prototype assay cartridges and instruments, software.
• Prepare technical reports and protocols for internal document control and tech transfer. Present results at lab meetings and participate in lab discussions. Provide input to research reports, journals and/or articles, including literature searches.
Qualifications:
• B.S. or M.S. in molecular biology, biophysics, chemistry, biochemistry, or closely related field, experience with nucleic acids hybridization, bioconjugation: 3-5 years for B.S., 1-3 years for M.S.
• Experience with validation of new diagnostics and devices in conjunction with 510(k)/PMA filings with U.S. FDA desirable; familiarity with GLP guidelines, ISO 13485 and other quality control management systems desirable.
Wave 80 Biosciences, Inc. is an Equal Opportunity/Affirmative Action Employer.
*****************************************************************************
Contact
Ronald H. Coelyn
[pic]
E-mail: rcoelyn@
Phone: 817-424-3652
web:
The first client Company has been associated with innovation in providing world-class pathology and diagnostic services, and, increasing the utility of genomic science discovery for many years. The Company’s mission is to bring the findings of research to physicians in the community setting and provide important decision-making tools that advance the treatment, management, and care of their patients. The Company's research collaborations with premier proteomic and genomic investigators are forging new and exciting pathways in the expanding arena of molecular medicine. These innovations are fundamentally changing the delivery of healthcare.
The Company has assembled a prestigious scientific advisory board of renowned scientists and physicians to assist in providing overall leadership and guidance.
Senior Vice President, Medical Affairs
The Senior Vice President, Medical Affairs is a key position. Reporting to the Executive Vice President & Chief Operating Officer, the Senior Vice President, Medical Affairs will be responsible for oversight and management of all activities related to the support of marketed inventions and identification of post-launch product improvements for the Company. This executive will spend the majority of her/his time providing leadership for the cancer registry and evidence teams, coordination of Key Opinion Leaders (KOLs) to drive evidence, influential engagement with reimbursement and provider plans, management of post-market clinical trials, and executing the Company's strategic objectives. The Senior Vice President, Medical Affairs will have demonstrated ability in successfully working in a high growth, rapidly developing enterprise and will have the intellectual vigor and hands on orientation that will be required for success.
In order to be considered candidates must be/have:
• A highly intelligent, seasoned individual with a solid track record, ten (10) to fifteen (15) years in duration, of demonstrated ability to successfully manage medical affairs. She/he will have earned progressively responsible roles; ideally working with large Fortune 500 organizations.
• A track record of working effectively with physician customers and successful customer relations management. This should include experience interacting with KOLs.
• An advanced level education, i.e., M.D., Ph.D., or possibly a PharmD, is absolutely required. A master’s level scientific degree in medical oncology would be preferred. Oncology experience is required and experience in healthcare services is preferred.
• She/he will possess demonstrable knowledge and experience with biomarkers and/or other molecular diagnostics.
The Company is publicly traded and profitable with significant positive cash flow and a strong balance sheet.
The position is located in the Midwest. That said, he/she must demonstrate the ability to work effectively with a great deal of autonomy.
_____________________________________________________________________________
The second client, East Coast based, has developed and has been marketing for several years, a line of diagnostic imaging equipment.
Member, Corporate Board of Directors
The new member of the Board of Directors should currently be, or have been, a Chief Executive Officer. Ideally, she/he will have extensive diagnostic imaging experience and both domestic and international contacts.
The Company is privately-held and financed by leading venture capitalists that are committed to this organization's rapidly developing, very bright future.
****************************************************************************
*****************************************************************************
Other Information for Those in Transition
**********************************************************************************************
*****************************************************************************
Science/UCSF Biotech Career Day, Thursday, April 1, 2010
Event: Science/UCSF Biotech Industry
Career Day
Date and Time: April 1, 2010, Workshops: 10:00 a.m. - 4:00 p.m.
Recruiters available: 1:00 p.m. - 4:30 p.m
Location: UCSF Mission Bay Campus - Genentech Hall, 600 16th Street, San Francisco, CA
Cost: Free to attendees; open to all; no registration required
Visit the Mission Bay campus for a chance to get valuable advice from career experts and to meet face to face with recruiters from some of the world's top scientific organizations. Don't miss this opportunity to connect with staffing professionals and hiring managers from the companies you want to work for.
Science and UCSF are teaming up to bring you a unique biotech day that includes five career development workshops and a chance to meet face to face with recruiters.
Details at
Workshops:
• Industry Career Paths - 10:00 a.m. - 11:30 a.m.
(Brianna Blaser, Project Director for Outreach, Science Careers/AAAS, and panel)
Join us for a panel discussion with Ph.D.-level scientists who work in industry. Bring your questions to learn more about the opportunities in industry, the skills needed to succeed, and how to transition to your first year on the job.
• Transitional Education/Training for Alternative Careers in Science - 11:45 a.m. - 12:45 p.m.
(Victoria Sharma, Program Director for Bioscience, UC Berkeley Extension)
Transitioning to a new career can be daunting, but getting the latest up-to-date training can give you a leg up on the competition. Explore new training options for various bioscience careers such as clinical and regulatory sciences and biopharmaceutical business.
• Making Connections: Networking and Career Fairs - 1:00 p.m. - 2:00 p.m.
(Brianna Blaser, Project Director for Outreach, Science Careers/AAAS)
This presentation will teach you the basics of good networking and how to employ those tactics in a career fair setting. Strategize about how to make the most of a career fair, how to introduce yourself, and what to do after the event is over. Using the techniques you learn will help you make the most of the career fair.
• Job Hunting in the Biotech Industry - 2:15 p.m. - 3:30 p.m.
(Bill Lindstaedt, Director, Office of Career and Professional Development, UCSF)
Learn how to prepare resumes and cover letters for your industry job search. Also, you will learn about job search strategies necessary for success on the biotech/pharma job market along with some tips for interview success and effective negotiations after you receive your job offer. After this seminar you will understand how to apply the four job hunting techniques that comprise a comprehensive job search in the biotech industry.
• Q&A: An Open Forum with UCSF Career Counselors - 3:30 p.m. - 4:00 p.m.
How to Prepare for the Career Event
You will need to bring several copies of your resume/CV for recruiters who may request them. Read Making the Most of Career Fairs for good advice.
******************************************************************
Bioscience Business and Marketing Essentials, Thursday and Friday, April 15-16, 2010
2-Day Intensive Course: Bioscience Business and Marketing Essentials, Thursday and Friday, April 15-16, 2010 with 2 months to complete project
Lead Instructor: Audrey S. Erbes, Ph.D., Principal, Erbes & Associates and
Expert Guest Speakers:
▪ Donald Holsten, Pharm. D., Regulatory Consultant and Educator
▪ Bev Hudson, MBA, General Manager, Clinical Research Services, MedPoint Communications, Inc
▪ Julie Tompkins, MBA, Sr. Vice President, Timely Data Resources (TDR)
Please see ucsc-extension.edu/biobusiness for complete biographies
Date & Time: April 15-15, 2010, Thursday and Friday, 8:30am-5pm
Location: UCSC Extension in Silicon Valley, 2505 Augustine Drive, Santa Clara, CA 95053
Fee: $750; $675 through April 1
Topic Description
The bioscience industry is like no other. Lengthy timelines and unique financial, legal, regulatory, social and political challenges impose constraints that impact every aspect of the business. This course helps participants gain: a practical understanding of the bioscience industry landscape, key business drivers and challenges; insight into the critical roles that business and marketing disciplines play at all stages of a bioscience company's development; and hands-on experience implementing important bioscience business processes that are essential to success within the industry. Two days of intensive classroom are followed by 2 months to complete individual project with guidance of instruction and access to research resources. For more information: See ucsc-extension.edu/biobusiness.
Instructor Bio
Audrey Erbes, Ph.D., Principal of Erbes & Associates and , is a marketing consultant with more than 30 years of managerial experience in marketing and business development in the biotech and pharmaceutical industries. She was Executive Vice President and cofounder of Kowa Research Institute, a biopharmaceutical licensing and investment subsidiary of Kowa Company Ltd., Japan and before that held management positions at Syntex Corp. in market research, product management, strategic marketing and planning, and business development in the U.S. and abroad.
*******************************************************************
Bioscience Business Development: Building Value, Thursday and Friday, June 24-25, 2010
Intensive Course: Bioscience Business Development: Building Value, Thursday and Friday, June 24-25, 2010 (2 days of classroom and 2 months to complete project guided by instructor)
Instructors: Audrey S. Erbes, Ph.D., Principal, Erbes & Associates and and and Gilbert R. Mintz, Ph.D., President of GRM Associates
Expert Guest Speakers:
▪ Harold (Hal) Etterman, MBA, Business Strategist
▪ Carolyn Feamster, MBA, VP, Business Strategy & Analysis
▪ Ginger R. Dreger, M.S., J.D., Partner, Arnold & Porter LLP
▪ Tom Gutshall, Chairman & Co-Founder of Cepheid
▪ Michael G. McCully, M.S., Director, Recombinant Capital
Please see ucsc-extension.edu/biobizdev for details
Date & Time: June 24-25, 2010, Thursday and Friday, 8:30am-5pm
Location: UCSC Extension in Silicon Valley, 2505 Augustine Drive, Santa Clara, CA 95053
Fee: $795; $715.50 through June 10
Topic Description
UCSC Extension in Silicon Valley presents a two-day intensive course that brings the breadth of the Bay Area’s biobusiness development expertise to our Cupertino classroom. Whether financing start-up activities, trying to keep pace with the current burn rate, or moving a product into the marketplace, bioscience companies, both large and small, have a critical need for business development at every stage of their evolution. Learn the key roles that business development and licensing play in the commercialization of a new product and the development of a successful bioscience company. Santa Clara, CA. For more information, see ucsc-extension.edu/biobizdev
Instructor Bios
Audrey Erbes, Ph.D., Principal, Erbes & Associates and has more than 30 years of marketing experience in the biotech and pharmaceutical industries, of which 25 years was in corporate management at Kowa Research Institute and Syntex Corporation.
Gilbert R. Mintz, Ph.D., President of GRM Associates, a biotechnology consulting firm with expertise in business development, licensing and strategic planning.
***************************************************************
Paula Rutledge, President of Legacy MEDSearch, has provided the following
Job Search and Interview Preparation Resources to share with you:
▪ Interview Preparation Resources: Interview Prep Guide
▪ Medical Device Research Forum Medical Device Guru
▪ LinkedIn Medical Device Group LinkedIn Medical Device Group
▪ Interviewing Videos on YouTube Medical Career Magazine
Although the above was developed with medtech professionals in mind, the processes outlined are also useful for other industry professionals.
*****************************************************************************
Ken Wu advises “I found this article titled, 7 Mistakes Job-Seekers Over 50 Make, via the American Society of Quality (ASQ) daily email update. It's worth reading if you're considering how to reposition your self for the upturn in the job market.”
The link; .
*****************************************************************************
Job Sites
The most known site for career and job listings is which focuses on biotech and pharma.
A newer website which includes jobs but also a virtual exhibit hall for companies—this one is dedicated to pharma entitled at
There’s another site which is focused on life science recruitment and placement; note featured company listings each week—
There’s website with jobs specific to medical device area at the .
Another new site with listings of interns, consultants and some jobs is
I’ve just received information on another new site with sole focus on medical devices and most in the Bay Area is I’m told they had 97 placements last year. Check this one out and let me know if you have good results.
You can look up pharmaceutical jobs in your area by zip code at . They include all functions in pharmaceutical companies.
*****************************************************************************
Other Helps
I received Biotech Ink Insider from Susan Caldwell, a local medical writer. She always has great insights as well as jobs at times to share. I’ve pasted in some videos mentioned by Susan that might be of interest for your job search:
Writing a Resume: When seeking a job, the resume is of considerable importance--it's your calling card and door opener. Here's a video that helps you create the right resume and minimizing the stress while you do it. Includes ten rules for how to approach your resume, interview, and job search. Very good basic advice.
Writing Your Resume Cover Letter: Same instructor as for Writing a Resume (above). Gives good basic advice on how to craft your cover letter and get the job interview you seek.
The Art of Medical Writing: Short video on the Masters in Medical Writing program at the University of Philadelphia, the only such training program in the world.
*********************************************************************
Susan Caldwell wrote an article regarding writing a resume as well.
“10 Tips for Creating a Door-Opening Resume” by Susan E Caldwell
If you're a medical writer, how can you make sure that you still have work in these tough economic times? Important for staff and freelancers alike, marketing your name and abilities can be done in many ways. One way is to develop and maintain a living resume that speaks to the best you have to offer employers.
As an experienced worker, you likely have a professional reputation. Maybe it's good, or maybe it's not so good. How can you enhance or improve your resume so that your best shines through? Here are a few suggestions:
1. Resume Format. Your resume's format should be simple and pleasing to the eye. Because resumes are often input into databases, the simpler the format, the better. Using a simple format should help avoid the need to reformat before your resume is uploaded into a database. When you submit your resume to a recruiter or job board, you should submit it as a Microsoft Word file, but without special formatting. Avoid bullets, bolding, italics, indents, and other formatting that are lost in plain text files. If you do use special formatting, your resume may look like alphabet soup after it's put in a database.
Organize your resume in sections, each with a heading that tells the reader what is in that section. Here are some sections typically found in resumes and their approximate order of appearance:
Introduction or Career Goal
Summary
Work History or Professional Accomplishments (if candidate has work history)
Academic Background
Skills
Honors and Awards
Publications
There are many variations on the organization and section labels listed above, and you should use what is appropriate for your career stage. Points 7-10 (below) specifically address what content should be included in some of your resume's major sections.
When you are ready to format your resume, consider looking at the many examples of resumes available online. Seeing the structures of other resumes may help you decide on your own resume's format and organization.
2. Job Targeting. Decide what your target job or assignment is, and tailor your resume to that job. How do you do that? For one thing, you can pepper your resume with the key concepts, terms, and abbreviations for your target job in your resume; this will show that you know the language in that field. Examples include the terms ICH Guidelines, investigator brochure (IB), style guide, and eCTD. Another way to target your resume is to rewrite portions of your resume to match the target job description. This strategy sounds like a lot of work, but it can pay huge dividends. When you submit a targeted resume, it's more likely you will be considered a great match for the position.
3. Resume Emphasis. Emphasize your best accomplishments (for example, an approved eCTD submission that you worked on). Make it clear that you got the job done in an effective way, particularly if it saved time or money. You can do this by positioning these stellar achievements toward the resume's front, writing more about those accomplishments, and/or including specific comments about them in your resume. If there's a web site or information on the web that illustrates or supplements information about your accomplishment, link that information to your resume.
4. Lying on Your Resume. This one is simple: don't lie on your resume. It's a bad idea for several reasons. Not only is it wrong, but if you exaggerate or lie, you may be in over your head if you do get the job. In addition, employers do check resume facts, and they are likely to identify any lies or inconsistencies.
5. Errors in Your Resume. If you're seeking a new job or contract assignment, your resume should be flawless. That is, it should have no typos, misspellings, incorrect grammar, or other writing errors. If you want to open the door to a job interview, show the reader that you are careful about your writing. As a medical writer, the writing that appears in your resume will be the first writing sample an employer sees. Be sure that it will stand up to scrutiny.
6. Resume as Living Document. Ensure that your resume is always current and well crafted; it should be a living document. Update it every time you have new material to add to it. Again, the resume's purpose is to get your foot in the door for an interview. If you don't keep your resume current, you may miss a chance to include vital information, especially if you need it on short notice. For this reason, you should always be ready to send your resume to recruiters or employers on a moment's notice.
The remaining points in this article address issues within your resume's sections:
7. Summary. At the start of your resume, include a short (usually 1 to 2 paragraphs) thumbnail summary of your work experience and academic background. It's also appropriate to have a statement that tells the reader what your want to do in your next job.
8. Academic Background. The academic background section should include your earned degrees, the name of the institution where you earned the degree, and the dates when they were conferred. If you have earned an advanced degree, this section may be a good place to list the title of your thesis or dissertation, if any. (Alternatively, your dissertation's citation can be included in your resume's Publications section.)
A separate section following your academic background can include the continuing education and training courses you've taken. The list should include the subject matter (or course title) and date(s) when you had the training. And here's an important tip: whenever possible, include specific dates for the education and training. The dates add to your credibility, and their absence can be conspicuous.
As you advance in your career, your academic background generally becomes less important than your work history. After you have a work history, especially in medical writing, consider moving the academic background information in your resume to a location following your work history.
9. Work History or Professional Achievements. In this section of your resume, include specific details about your work history. The reverse chronological work history format often works well, with your most recent job listed first. The work history section should describe your milestone accomplishments for each job or contract assignment. As with the academic background section, include the start and stop dates for the jobs and/or contract work that you've done. The dates will give you added credibility.
10. Publications. If you've authored any publications, put a list of them in your resume with the full citations in a consistent reference format. For publications with multiple authors, you should include all of the authors' names in the order that they appeared in the publication. Finally, try to get access to electronic copies of your publications on the internet. Consider hyperlinking those citations in your resume to the actual articles. In so doing, your reader can easily find and read examples of your work. You can also prepare a set of publication samples as a zipped file to provide to prospective employers.
Done well, your resume will open many doors for you, including some you may want to walk through. There are many resources on the internet that will help you create an excellent resume. Take the time to use them, too! You'll be glad you did.
[pic]
About the Author
Susan Caldwell is a medical writer, PhD scientist, and entrepreneur. After 10 years of laboratory research, she made a major career course correction and never looked back. She found she could make a career of doing what she loves--writing--and applied it to her background in biomedical research. Since 1995, she has directed medical writers at five life-science companies, including her company, Biotech Ink, LLC. Her specialty is writing regulatory documents for clinical, preclinical, and manufacturing activities that support the development of biotechnology, pharmaceutical, and medical device products. She also has considerable experience writing book chapters, newsletters, brochures, white papers, web content, and many other document types. Susan has been writing and publishing the Biotech Ink Insider newsletter since October 2008.
You can email Susan at caldwell@, phone her office (650-286-9300), see her LinkedIn profile, follow her on Twitter, and you're invited to join her Medical Writers Twibe (for which you have to have a Twitter account).
Copyright 2009 Biotech Ink, LLC. All rights reserved.
*****************************************************************************Susan E. Caldwell a local medical writer shares some insights into finally mastering touch typing.
As writers, we must type to do our work, at least if we're using Microsoft Word or other word processor. Many writers become writers without knowing how to touch type (typing without looking at the keys). Touch typing at 40-60 average words per minute, which is industry standard, is roughly 3 to 4 times faster than you can write by hand. The links below are offered so that you can learn and practice touch typing for free (and they aren't presented in any particular order:
1.
2.
3.
4.
5.
6.
7.
8.
*****************************************************************************
Salary Surveys
▪ See free downloadable annual Salary Survey from Contract Pharma at
▪ Salary surveys are regularly published Medical, Marketing Media each year in September
▪ See 2009 Medtech salary survey at Source:
****************************************************************************
Given the current economic climate, this is a wonderful time to prepare for a career transition and to reassess your career path so that it is aligned with your personal and professional goals. Career Opportunities in Biotechnology and Drug Development, , published by Cold Spring Harbor Laboratory Press, is a comprehensive, in-depth exploration into the many careers found in the life sciences industry (biotech, pharma and medical devices), based on interviews with over 200 industry executives. It covers 20 vocational areas and over 100 careers. The book was written with the goal of helping readers identify career areas that best suit their interests, values, skills and goals. Each chapter explores the many in-depth nuances of each vocational area. Additionally, there are chapters on resume preparation, job search strategies, informational interviewing and more. A free sample chapter on careers in Project Management is available at .
This insightful and extremely helpful book was researched and written by Toby Beth Freedman, Ph.D., President, Synapsis Search () and local guru on life science careers. Toby freely shares her experiences acquired as a researcher, business development manager, recruiter and her indepth research with local industry organizations, such as, local AWIS, the Bio2Device Group and universities.
The target audience for this book is people working in academia or in industry who are considering a career transition. It has a broad appeal to scientists, doctors, nurses, lawyers, engineers, business executives, high tech professionals, etc. The book is available on Amazon and a paperback version will be available soon.
****************************************************************************
These job postings are listed on my blog accessed at along with my suggestions for local industry meetings for networking and expanding your knowledge and skills. Please direct other interested parties to my email address at audreyerbes@ if they wish to receive these mailings directly.
*****************************************************************************
................
................
In order to avoid copyright disputes, this page is only a partial summary.
To fulfill the demand for quickly locating and searching documents.
It is intelligent file search solution for home and business.
Related searches
- jobs that people enjoy
- best jobs that only require certification
- technician jobs that pay well
- jobs that are hiring
- jobs that require compassion
- jobs that pay well without a degree
- jobs that need help now
- jobs that are hiring immediately
- free online jobs that pay
- jobs that serve others
- business jobs that pay well
- easy jobs that pay well