Note: The job is a remote job and is open to candidates in USA. Amylyx Pharmaceuticals is a clinical-stage company focused on treating diseases with high unmet needs. The Senior Vice President of Clinical Development will provide strategic direction and leadership to the clinical development team, overseeing clinical trial design and execution, and aligning the clinical development plan with the overall product strategy.
Responsibilities
- Develop and implement comprehensive clinical development strategies aligned with Amylyx's mission and business objectives
- Lead and mentor a multidisciplinary team of medical directors, pharmacologists, and clinical development scientists, fostering a culture of collaboration and excellence
- Oversee the design, execution, and analysis of clinical trials, ensuring adherence to timelines, budgets, and regulatory requirements
- Collaborate with regulatory affairs to develop and execute strategies for regulatory submissions and interactions with health authorities
- Establish and maintain relationships with key opinion leaders, clinical investigators, and external partners to support clinical programs
- Develop and manage the clinical development budget, ensuring optimal resource allocation and fiscal responsibility
Skills
- Experience: Minimum of 15 years in clinical development within the biotechnology or pharmaceutical industry, with significant experience leading teams in rare disease drug development
- Leadership Skills: Proven ability to lead cross-functional teams, foster cross-functional collaboration and manage multiple projects in a fast-paced environment
- Regulatory Knowledge: In-depth understanding of global regulatory requirements and experience with regulatory interactions and submissions
- Communication Skills: Excellent verbal and written communication skills, with the ability to effectively present complex information to diverse audiences
- Educational Background: MD or MD/PhD with specialization in Neurology or Endocrinology preferred
- Experience: Successful BLA/NDA/MAA submission(s) and clinical/medical support of product commercialization preferred
Benefits
- Remote work opportunities within the United States
- Travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested
- Access to work in setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location
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