Senior Vice President, Clinical Development

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.

Required Qualifications

• MD or MD/PhD with specialization in Neurology or Endocrinology preferred.
• Minimum of 15 years in clinical development within the biotechnology or pharmaceutical industry, with significant experience leading teams in rare disease drug development.
• Successful BLA/NDA/MAA submission(s) and clinical/medical support of product commercialization preferred.
• Proven ability to lead cross-functional teams, foster cross-functional collaboration and manage multiple projects in a fast-paced environment.
• In-depth understanding of global regulatory requirements and experience with regulatory interactions and submissions.
• Excellent verbal and written communication skills, with the ability to effectively present complex information to diverse audiences.