The Global Affairs Medical Director will provide medical leadership for medical affairs strategy, planning and supportive tactics for assigned therapeutic area. Under the direction of the Executive Medical Director, this role will be responsible for working with key stakeholders to develop and execute the medical affairs plan, including new indication launches, post-marketing research, medical education, research grants, medical advisory boards, and scientific communication/publication components of overall medical operating plan. Provide strategic development, planning, implementation, and oversight of Phase IV clinical trial programs within the Medical Affairs department for products in the therapeutic area. The Medical Director will utilize expert medical/scientific knowledge in assigned therapeutic area to provide strategic input for the development of product strategies and liaise with external stakeholders to solicit feedback and strengthen company’s medical reputation in the disease state community. This role is responsible for approval of medical and scientific content of all relevant materials/communications.
typical roles and responsibilities for Global Affairs Medical Director
Medical Affairs Strategic Plans: Under the direction of the Senior Medical Director, work with key stakeholders, management, and functional area leads to develop strategic and aligned Medical Affairs Plans for the therapeutic area. Communicate and represent these plans to upper management/senior leadership within ESI. Continuously update plans and inform stakeholders of progress. Medical Launch preparation and execution will be a major part of this position.
Phase IV clinical studies: Direct and design strategies, planning and implementation of Phase IV clinical development programs for assigned products. Provide medical oversight for protocol development, interpretation of trial results, final study report conclusions and publications. Serve as study director for trials. Provide critical medical input into the lifecycle management strategies in responsible therapeutic areas.
Medical/Scientific subject matter expert: Serve as medical leader and subject matter expert providing direction for assigned products including (but not limited to) CRC, scientific communications, publication planning/review, advisory boards, health outcomes plans, MSL activities, speaker programs, investigator-initiated research and CME grant reviews or other internal key business processes. Responsible for approval of medical and scientific content of Regulatory, Safety, Scientific Affairs, Medical Affairs and Commercial outputs for assigned therapeutic areas.
External leadership: Provides leadership and strategic direction to stakeholders in interactions and communications with external customers, thought leaders, strategic alliances, key organizations, and institutions. Maintains external orientation by participating actively in external events and activities. Strengthen medical reputation through successful management of medical dimensions of products.
Requirements for Global Affairs Medical Director – Life Sciences
Board Certified in therapeutic area and US fellowship training, or MD with 4-5 years’ experience in within the pharmaceutical industry including 2 years in-house Medical Affairs role, or PhD or PharmD with 6 years’ experience within the pharmaceutical industry, including experience in the therapeutic area and 5 years in an in-house Medical Affairs role.
Clinical research experience, including conducting/participating clinical trials in the Phase IIIb-IV area. Experience reviewing promotional materials from a medical perspective, publications planning, relevant medical society membership and track record of active participation/attendance, and strong presentation skills.
Experience working with cross functional medical and commercial teams.
Oncology therapeutic Area Expertise including standards of care, current medical options for diagnosis and treatment of relevant conditions based upon franchise products.
Experience in medical affairs launch of oncology molecules
Understanding Medical Affairs Activities
Understanding of Marketing concepts/strategies
Knowledge of the pharmaceutical marketplace
FDA regulations/ICH guidelines regarding conduct of clinical studies in relevant therapeutic area.
Knowledge of regulatory guidance regarding marketing/sales promotional materials
Strong overall written and verbal communication skills
Must have requisite skills to function in a complex and dynamic environment, including flexibility and ability to negotiate.
ICMJE guidance/general publication practices
Current ACCME guidelines
Sound computer skills including Microsoft Word, and PowerPoint