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Vice President, Phase IV & Epidemiology
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Vice President, Phase IV & Epidemiology : MedImmune, LLC.
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| Job Number |
01856 |
| Employee Type |
Full Time |
| Company Name |
MedImmune, LLC. |
| Location |
Gaithersburg
Maryland
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| Salary (year) |
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| Start Date |
2/9/2010 |
| Industry |
Biotech |
| Job Type |
Medical-Affairs |
| Relocation |
Not Required |
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| Description |
Description Title: Vice President, Phase IV & Epidemiology
Location: MD, Gaithersburg - Corporate Headquarters
Req: 01856
Major Duties and Responsibilities (including supervising others):
• Provide strategic vision and leadership to the Phase IV and epidemiology team within the department of Medical & Scientific Affairs. Supervise staff including medical epidemiologists (direct reports) as well as biostatisticians and clinical operations support personnel (dotted line reports). Set strategic priorities for the program and assume responsibility and accountability for oversight of execution.
• Oversee the design and conduct of Phase IV trials and epidemiologic studies to support product brand strategies and global regulatory requirements. Examples include, but are not limited to, design and execution of product registries, as well as retrospective and prospective studies aimed at defining burden of disease and disease risk factors.
• Provide epidemiology and observational study design expertise to the discovery, development, and commercialization of biopharmaceutical products across the therapeutic areas represented at MedImmune.
• Generate, evaluate, and refine post-marketing and epidemiology research proposals, align proposals to the company’s strategic objectives, and advise senior management on the benefit/risk assessment of such projects.
• Provide senior direction and leadership to project directors and medical monitors on Phase IV interventional trials and other studies as appropriate.
• Provide clinical trial design and analysis consultative expertise in support of early and late stage clinical development and business development activities.
• Collaborate closely with clinical scientists, health economists, safety experts, regulatory professionals, and others within and outside the company to identify key issues related to product support, and formulate plans for proactively addressing these issues.
• Advise the therapeutic area teams on publication planning strategies, and ensure that scientific data resulting from Phase IV and epidemiology team projects are presented at major medical and scientific meetings and published in peer-reviewed journals. About the Organization My company shares my
passion for helping to improve human health around the world."
"This is My MedImmune."
Those who join MedImmune feel a sense of ownership about their future. They thrive with a recognized leader in the biotechnology industry and the wholly-owned subsidiary of AstraZeneca plc.
Here, you will join passionate professionals who advance science, technology and medicine to develop products designed to help people live better lives. You will excel in an environment characterized by respect, integrity and growth opportunities…that encourages both individual contribution and collaborative entrepreneurial thinking. Our products and/or product candidates are designed to address areas of need in infection, oncology, respiratory disease and inflammation, cardiovascular/gastrointestinal disease and neuroscience. Explore a MedImmune career as we strive to better more lives, more often, around the world. Company Information MedImmune, LLC. is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law.
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| Requirements |
Position Requirements Special Skills/Abilities: Expert research and analysis skills and a track record of publications. Excellent communication, interpersonal, and organizational/administrative skills. Proficiency in project management and in forecasting and negotiating project budgets. Knowledge of relevant FDA, EMEA, ICH, CIOMS and GCP standards and guidelines.
Job Complexity: Will direct teams to work on projects of diverse scope and complexity. Expected to exercise independent judgment within generally defined practices, guidance and policies.
Supervision: Should be highly motivated and work well with minimal supervision. Supervision of direct reports and of external vendors will be required. Educational Requirements Education: MD degree with training in preventive medicine, internal medicine, or related specialty, with postgraduate training (MPH or PhD degree) or equivalent experience in epidemiology.
Experience: At least 5 years of industry experience. National regulatory, or other relevant work experience is desirable. Knowledge and hands-on experience required with all phases of clinical trial design and conduct, and with methods of analysis of large healthcare databases. Experienced manager who has supervised and mentored epidemiologists and physicians engaged in clinical research.
MedImmune does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on MedImmune’s approved agency list. Unsolicited resumes or candidate information submitted to MedImmune by search/recruiting agencies not already on MedImmune’s approved agency list shall become the property of MedImmune and if the candidate is subsequently hired by MedImmune, MedImmune shall not owe any fee to the submitting agency.
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