Position: Medical Director, US Medical Affairs - Alzheimer’s Disease Job 2489
Location: Northern NJ/Hybrid Work Schedule: 2 days a week in office/3 days a week WFH
Compensation: Competitive Salary and Benefits are Based Upon Experience
Summary: The Medical Director, US Medical Affairs provides medical leadership for medical affairs strategy, planning and supportive tactics for assigned therapeutic area. This role is responsible for working with key stakeholders to develop and execute the medical affairs plan, including post-marketing research, medical education, research grants, medical advisory boards, and scientific communication/publication components of overall medical operating plan. The Medical Director provides 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 utilizes expert medical/scientific knowledge in assigned therapeutic area to provide strategic input for the development of product strategies and liaises with external stakeholders to solicit feedback and strengthen the Company’s medical reputation in the disease state community. The Medical Director is responsible for approval of medical and scientific content of all relevant materials/communications.
Essential Functions:
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. Continuously update plans and inform stakeholders of progress.
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.
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.
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 the Company’s medical reputation through successful management of medical dimensions of products.
Requirements:
MD is preferred. PhD or PharmD with 5+ years of experience within the pharmaceutical industry, including experience in the therapeutic area.
Clinical research experience, including conducting clinical trials in the Phase IIIb-IV area.
Expertise in Alzheimer's Disease is REQUIRED.
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.
Therapeutic Area Expertise including standards of care, current medical options for diagnosis and treatment of relevant conditions based upon franchise products
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
CMJE guidance/general publication practices
Current ACCME guidelines
Sound computer skills including Microsoft Word, and PowerPoint
Familiarity with statistical methodology
PhRMA Code.