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 Senior Director/Vice President of Medical Affairs

Details
Country: USA
Location: Massachusetts-Boston Lexington
Total applied: 34
Job Category:Biotech/R&D/Science
Location:US-MA-Lexington
Status:Full Time, Employee
Occupations:Clinical Research;General/Other: R&D/Science;Pharmaceutical Research
Career Level:Experienced (Non-Manager)
Senior Director/Vice President of Medical Affairs

This position will report to the Senior Vice President and Chief Medical Officer. The individual is responsible for building the company's entire medical affairs department including Investigator sponsored trials, the medical drug information function, clinical publications, future phase IV studies, and managing the Synta MSL team. As the head of medical affairs, he/she will play a significant role in developing and fostering relationships with physicians and thought leaders in the oncology community. This also includes leading the planning, design and development of departmental processes and systems to support Medical Affairs activities. This role requires close collaboration with Synta's clinical and commercial teams, as well as our strategic partner, GlaxoSmithKline.

Responsibilities:

Medical oversight to Clinical Affairs department Lead the evaluation and approval of IST proposals Provide medical oversight during the execution of investigator-sponsored clinical trials



Product Development and Business Strategy

Collaborate with academic leaders and technical consultants to ensure that Synta's oncology products serve the clinical needs of patients and based upon their safety and efficacy Collaborate with clinical and commercial to develop strategies that support real world clinical expectations that can be brought through the clinical pathway in an expeditious manner Chair various committees regarding the review of promotional materials, unsolicited medical communications, publications, etc. Work closely with our strategic partner GlaxoSmithKline on collaboration topics Manage a US-based MSL team of 6 professionals

Qualifications:

Minimum of M.D. with specialty in oncology A minimum of 5-7 years of combined relevant experience in a medical/clinical environment, particularly within medical affairs in the pharmaceutical industry is required. In-depth knowledge of study methodology, study data reviews and analysis Excellent knowledge of study execution, benefit risk management and regulatory affairs Experience serving as the medical affairs representative on review teams to develop promotional materials, medical communications, etc. Highly innovative and motivational with the ability to drive a complex and changing environment and effectively manage and resolve issues Proven ability to act as a medical spokesperson for external audiences is required Strong experience developing and managing strategic relationships with medical experts/opinion leaders Experience working within FDA requirements and other government and industry groups (OIG, PhRMA, etc.) Strong communication skills to effectively connect with the scientific and medical community Demonstrated ability to set strategic direction and lead teams in a dynamic scientific and medical enterprise Exceptional interpersonal communication skills Willingness to take initiative and become directly involved in planning, problem solving and execution of work in a team environment Willingness to travel extensively, both in the US and abroad

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