Senior Vice President, Clinical Development

Amylyx Pharmaceuticals • Cambridge, MA

4d • Remote

About The Position

Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS). Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine’s toughest problems, we encourage you to read the opportunity below and apply. The Opportunity 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. In addition, this individual will participate in various business development evaluations, as applicable. Overall, the main responsibility will be to provide strategic leadership for the clinical and medical aspects for the various programs and work closely with a cross-functional team to align the clinical development plan with the overall development strategy of the relevant products. Furthermore, this individual will have the opportunity to oversee the clinical development of multiple product candidates that represent different modalities and are at different stages of development from first in human to pivotal trials.

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.
• 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.

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.

Benefits

• The pay range posted below represents our good faith estimate of compensation for this role, based on market data and internal benchmarks. The final offer may vary depending on a candidate’s experience, skills, and qualifications, as well as considerations of internal equity. Estimated Pay Range $416,000 - $468,000 USD

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Ph.D. or professional degree