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About Amylyx Pharmaceuticals

Amylyx Pharmaceuticals is a biotechnology company focused on developing therapies that improve patient lives. We are seeking a Senior Medical Director, Clinical Development to lead the strategy and execution of our clinical development programs.

About the Role

The Medical Director, Clinical Development will oversee clinical development activities, design trial programs, and ensure alignment with regulatory expectations. This role requires strong scientific leadership, cross-functional collaboration, and a patient-centric mindset to advance our portfolio.

Responsibilities

Lead the clinical development strategy across programs from early to late-stage trials.
Design, oversee, and monitor clinical trials, including study protocols and execution plans.
Collaborate with Regulatory, Biostatistics, Medical Affairs, Safety, and Commercial teams to ensure alignment and timely delivery.
Coordinate regulatory submissions and ensure compliance with GCP and applicable guidelines.
Communicate scientific and clinical findings to internal stakeholders and external partners.

Qualifications

MD/DO or PhD with substantial clinical development experience in biotechnology/pharmaceuticals.
8+ years in clinical development leadership, including trial design and execution.
Strong understanding of regulatory requirements and preparation of submissions.
Excellent cross-functional leadership, communication, and strategic thinking skills.
Ability to lead external collaborations and manage relationships withKey opinion leaders.

What We Offer

Competitive compensation, equity, comprehensive benefits, and the opportunity to shape impactful therapies for patients.

Amylyx