Senior Vice President, Clinical Development

Summary

Join Amylyx Pharmaceuticals as their Senior Vice President of Clinical Development! This leadership role requires strategic direction and technical leadership for the clinical development team, encompassing planning, trial execution, data analysis, and competitive intelligence. You will oversee multiple product candidates in various development stages, collaborating with cross-functional teams and key stakeholders. The position is remote, with a preference for New England-based candidates who can attend meetings in Cambridge, MA. Responsibilities include developing clinical strategies, leading and mentoring a team, overseeing clinical trials, engaging with regulatory affairs, and managing the budget. The ideal candidate will possess extensive experience in clinical development within the pharmaceutical or biotechnology industry, particularly in rare disease drug development.

Requirements

• 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
• 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

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

Preferred Qualifications

Successful BLA/NDA/MAA submission(s) and clinical/medical support of product commercialization

Benefits

Remote work