Medical Director, Medical Affairs and Strategic Development Job Listing at AstraZeneca in Wilmington, DE
This role will be based in Wilmington, with 2-3 days a week required at the 'launch pad' in Mount Laurel, NJ. When a new site is identified, it will become the primary location for the role A Medical Director MASD is a board-certified physician who has a history of clinical practice, who has significant experience in Diabetes. The Medical Director MASD will have experience in medical affairs and clinical development, is knowledgeable of the actions of regulatory bodies, in particular FDA and has experience in all aspects of clinical trials. They will have solid peer relationships with key opinion leaders in their therapeutic area. An ideal candidate should have significant experience in their medical specialty and would thrive on proactively engaging internal and external leaders and will serve as a medical expert for their brand and disease area. The ideal MDSD will also have strong commercial aptitude and/or experience, including proven ability to translate and align commercial and scientific goals and objectives. The candidate must be able to work across the BMS/AZ Diabetes Alliance by demonstrating strong interpersonal skills, the ability to influence without authority and be able to align the team on developing and delivering key objectives while maintaining a collaborative environment. Accountable:
* Medical input into key clinical brand activities including clinical trials, Real World Evidence ( RWE)
* All activities of study team physicians for US local trials including design of trials, medical oversight of trial conduct, data interpretation
* Ascertaining the medical accuracy of medical information in promotional material and learning materials for both internal and external use
* Medical input into brand strategy
* Interact with leaders of groups identified as strategic partners, including both payer and provider groups.
* Interact with leaders in the therapy area (KOL, Academic Institutions, Societies).
* Play an integral role in the planning and participation of national and regional medical advisory boards.
* Play an integral role in the planning and providing of training for external medical/scientific speakers.
* Provide clinical education and training for internal stakeholders such as regional scientific managers and members of product sales teams.
* Provide medical review in concert with cross functional team members for investigator-sponsored research proposals.
* Provide medical input into the Brand Team Investigator Sponsored Studies (ISS) program and Publication Strategies
* Maintain key links into global brand clinical activities by maintaining collaborative working relationship with TA medical physicians including Medical Science Director (MSD), Clinical Research Scientists.
* Supply medical input into safety profile of the product in collaboration with Patient Safety (PS) physicians
* Act as medical spokesperson for US Brand as needed for media inquiries or other external groups. Consultation:
* Work with brand teams to provide scientific and clinical expertise/input into strategic and tactical decisions in support of AstraZeneca products acting as medical expert for disease area.
* Supply medical insight into promotional material along with learning materials for internal and external use
* Actively contribute medical and scientific input to relevant internal Brand, Medical Affairs, and Managed Markets teams regarding product strategy.
* Actively contribute to medical input for global clinical activities with global TA physicians including global brand strategy, global clinical trials, brand safety profile discussions, global brand payer dossier
* As a Medical expert, supply medical input to the Design and Interpretation process (DI) for global Phase III programs and/or Life Cycle Management (LCM) programs Internal Contacts
* Member of Strategic Development group within Medical Affairs and Strategic Development
* Expected to work with multiple internal teams effectively.
* Works closely with global physicians including MSD, clinical research physicians and PS physicians
* Maintains close link with other Medical Directors
* Maintain close link with Director Medical Affairs or Senior Director Medical Affairs for the Brand(s) and TA
* Field visits in conjunction with Medical Affairs Managed Markets
* Reports to Development Brand Leader for their Brand Minimum Requirements
* Graduate of a recognized medical school and recipient of an M.D. degree or equivalent
* Specialty training and board certification in internal medicine, subspecialty certification in Endocrinology or equivalent highly preferred
* Clinical experience and strong academic track record in diabetes and metabolic disorders
* Background in clinical research and familiarity with biostatistics and epidemiology
* Excellent written and oral communication, interpersonal, and organization skills.
* High level of emotional intelligence
* Strong business acumen, including working knowledge of changing U.S. payer and provider landscape
* Proven ability to interact productively with both commercial and scientific colleagues
* Demonstrated ability to work collaboratively in cross functional teams
* Familiarity with DDMAC, PhRMA code, and key regulations in the pharmaceutical industry
* Highest level of ethics and integrity
* Ability to travel nationally and internationally. Travel will be ~30% of time.
* Medical Directors will have at least 3 years of pharmaceutical industry or other related areas of experience
* Other training such as an M.P.H., M.B.A. or other advanced degree
* Experience with pharmaceutical drug development and Medical/Scientific Affairs
* Active medical license
* Geographically located at the Wilmington, Delaware headquarters
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