About the Role
The Senior Medical Director, Clinical Development and Medical Affairs will demonstrate a strong understanding of all aspects of products, related disease states and related products in the marketplace. The Senior Medical Director will be responsible for providing strategic and scientific leadership for the clinical programs, as well as setting the clinical strategy for approved products and being involved with early-stage programs. The ideal candidate will serve as the primary point of contact for liaising with counterparts in regulatory, drug safety and pharmacovigilance, program management, commercial and other cross functional areas.
- Medical Doctorate, MD/PhD required.
- Experience in managing clinical trial conducts for CNS disorders is essential.
- 7+ years industry experience in CNS drug development and Medical Affairs.
- Strong understanding of development enterprise (P1-4 studies) with proven interactions with regulatory authorities at different stages of drug development.
- Firm working knowledge of GCP, scientific and clinical methodology, protocol design project management and regulatory requirements for clinical studies designated for review by regulatory authorities.
- Experience to include a well-documented history in medical development of CNS therapeutics and of building proactive relationships among product development, clinical development and marketing teams.
- Proven experience in product launches.
- Clinical experience in Neurology and/or Psychiatry is preferred.
- Board Eligibility in Neurology/Psychiatry preferred.
- Willing to travel 30%
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