New York City, NY
Not Specified years
Posted 268 days agoby Jack Trudeau
Sr. Medical Director ? Medical Affairs (Sleep Medicine)
Comp: 260k to 310k
Location: New Jersey
Relo Support: Yes
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 the company?s Sleep Pipeline, 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.
Responsibilities include but are not limited to:
- Development of Medical Affairs Strategic Plans: The Medical Directorworks with key stakeholders, management, and functional area leads to develop strategic and aligned Medical Affairs Plans for Sleep Disorders.
- Communicate and represent Medical Affairs plans to senior leadership and continuously update plans and inform stakeholders of progress.
- 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 Medical Director serves as the Medical/Scientific 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 otherinternal key business processes.
- The Medical Director providing External Leadership and strategic direction to stakeholders interactions and communications with external customers, thought leaders, strategic alliances, key organizations, and institutions.
- 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.
Skills and Experience
- MD - Board Certified in Neurology and/or Psychiatry with subspecialty in Epilepsy
or Sleep Medicine
- Medical Affairsexperiencewithin the pharmaceutical industry
- Clinical research experience, including conducting clinical trials in the Phase IIIb-IV
- 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.
- Experienceworking with cross functional medical, clinical development and Commercial teams.
- The ability to work independently