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Posted 3 hours ago
Senior Vice President, Clinical Development
Amylyx PharmaceuticalsSenior Vice President, Clinical Development
Requirements
MD or MD/PhD, 15+ years clinical development experience, Rare disease drug development experience, Regulatory submission experience
Skills
Clinical Research
About the role
Responsibilities
- Develop and implement comprehensive clinical development strategies aligned with company mission and business objectives
- Lead and mentor a multidisciplinary team of 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 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
- Develop and manage the clinical development budget
Requirements
- MD or MD/PhD with specialization in Neurology or Endocrinology preferred
- Minimum of 15 years in clinical development within biotechnology or pharmaceutical industry
- Significant experience leading teams in rare disease drug development
- In-depth understanding of global regulatory requirements
- Proven ability to lead cross-functional teams in a fast-paced environment
About the Company
Amylyx is a clinical-stage company focused on treating diseases with high unmet needs, including post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).
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Amylyx Pharmaceuticals · Cambridge
