Medical Affairs Director
Primary areas of focus may include Epilepsy, Sleep Medicine, Alzheimer’s Disease and Metabolics. Provide strategic development, planning, implementation and oversight of Phase IV clinical trial programs within the Medical Affairs department for products in the therapeutic area. Utilize expert medical/scientific knowledge in assigned therapeutic areas to provide strategic input for the development of product strategies. Liaise with external stakeholders and key opinion leaders to solicit feedback and strengthen company medical reputation in the disease state community. Responsible for review and approval of medical and scientific content of all relevant materials/communications. Interact with the PCU as medical affairs liaison for products in late stage development.
1. 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 areas. Communicate and represent these plans to upper management/senior leadership within ESI. Continuously update plans and inform stakeholders of progress.
2. 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.
3. 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.
4. 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 company medical reputation through successful management of medical dimensions of products.
5. Internal leadership: Serve as Medical Affairs liaison with PCU and BD on pipeline products (focus on Insomnia) providing input on clinical development plan, clinical trials, medical affairs launch preparation, publication planning, training, health outcomes strategic planning.
Job Qualifications • Board Certified in therapeutic areas (neurology/epilepsy/sleep disorders) with expertise in neurology/sleep medicine with US fellowship training OR MD/Ph.D. with 5-7 years’ experience within the pharmaceutical industry including experience in the therapeutic areas.
• Clinical research experience, including conducting clinical trials in the Phase IIIb-IV area. Experience reviewing promotional materials from a medical perspective, publication planning, relevant medical society membership and track record of active participation/attendance, and strong presentation skills.
• Experience working with cross functional medical, clinical development and commercial teams.
• Therapeutic Area Expertise including standards of care, current medical options for diagnosis and treatment of relevant conditions based upon franchise and pipeline 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.
• ICMJE guidance/general publication practices
• Current ACCME guidelines
• Sound computer skills including Microsoft Word, and PowerPoint
• Familiarity with statistical methodology
• PhRMA Code
Auto req ID 4081BR