The Medical Director, Medical Affairs will be responsible for working with key stakeholders to develop and execute the medical affairs plans for pipeline assets in Sleep and in support of current released compounds, including post-marketing research, medical education, research grants, medical advisory boards, and scientific communication/publication components of overall medical operating plans. The Medical Director provides strategic development, planning, implementation and oversight of Phase IV clinical trial programs within the Medical Affairs Department for specific products in the Neuroscience therapeutic area. Utilizing expert medical/scientific knowledge in assigned areas of focus, the Medical Director provides strategic input for the development of product strategies. The Medical Director liaises with external stakeholders and key opinion leaders to solicit feedback and strengthen Company’s medical reputation in the disease state community. The Medical Director reviews and approves medical and scientific content for all relevant materials/communications. The Medical Director interacts with the Medical Science Liaisons for products in late stage development.
Responsibilities include but are not limited to:
1. Development of Medical Affairs Strategic Plans: The Medical Director works with key stakeholders, management, and functional area leads to develop strategic and aligned Medical Affairs Plans for Sleep Disorders and current compounds. The incumbent will communicate and represent these plans to senior leadership and continuously update plans and inform stakeholders of progress.
2. Directing and Designing Phase IV Clinical Studies: The Medical Director directs and designs strategies to include planning and implementation of Phase IV clinical development programs for assigned products and provides medical oversight for protocol development, interpretation of trial results, and final study report conclusions and publications. The Medical Director serves as study director for trials. The incumbent provides critical medical input into the lifecycle management strategies.
3. Serving as the Medical/Scientific Subject Matter Expert: The Medical Director serves 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. The incumbent approves medical and scientific content for Regulatory, Safety, Scientific Affairs, Medical Affairs and Commercial outputs for assigned areas.
4. Providing External Leadership: The Medical Director provides leadership and strategic direction to stakeholders in interactions and communications with external customers, thought leaders, strategic alliances, key organizations, and institutions. The incumbent maintains external orientation by participating actively in external events and activities to strengthen Company’s medical reputation through successful management of medical dimensions of products.
5. Providing Internal Leadership: The Medical Director serves as Medical Affairs Liaison 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.
• Board Certified in Neurology and/or Psychiatry, ideally with subspecialty expertise in Epilepsy or Sleep Medicine with US fellowship training OR MD with 3-7 years of US Medical Affairs experience/ 5-7 years of experience within the pharmaceutical industry in combination with experience in assignment pipeline/approved product 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.
• The ability to work independently
• Therapeutic Area Expertise including standards of care, current medical options for diagnosis and treatment of relevant conditions based upon pipeline and marketed products