The Senior Vice President (SVP) of Clinical Development will provide strategic direction and technical leadership to the clinical development team, including clinical-regulatory development planning, clinical trial design, implementation and execution, clinical data analysis and management, and clinical competitive intelligence. This individual will also participate in business development evaluations, as applicable.
Responsibilities:
- Develop and implement comprehensive clinical development strategies aligned with business objectives.
- Lead and mentor a multidisciplinary team (medical directors, pharmacologists, and clinical development scientists).
- Oversee the design, execution, and analysis of clinical trials, ensuring adherence to timelines, budgets, and regulatory requirements.
- Collaborate with regulatory affairs on regulatory submission strategies and interactions with health authorities.
- Establish and maintain relationships with key opinion leaders, clinical investigators, and external partners.
- Develop and manage the clinical development budget.
Required Qualifications:
- MD or MD/PhD (specialization in Neurology or Endocrinology preferred).
- 15+ years in clinical development (biotech/pharma), with significant experience leading teams in rare disease drug development; successful BLA/NDA/MAA submission(s) and clinical/medical support of commercialization preferred.
- Proven leadership of cross-functional teams and ability to manage multiple projects in a fast-paced environment.
- In-depth knowledge of global regulatory requirements; experience with regulatory interactions and submissions.
- Excellent verbal and written communication skills.
Work Location:
- Remote; preference for candidates residing in New England who can regularly attend meetings in Cambridge, MA.
- Remote work requires appropriate work setup (privacy, reliable internet, phone, ability to video conference, etc.).