Medical Director, Clinical Development

Company: Amylyx Pharmaceuticals Location: Cambridge, Massachusetts

Position Overview

Amylyx Pharmaceuticals is a clinical-stage pharmaceutical company dedicated to developing novel therapies for high unmet needs. We are currently focused on conditions such as post-bariatric hypoglycemia (PBH), Wolfram syndrome, progressive supranuclear palsy (PSP), and amyotrophic lateral sclerosis (ALS). We are seeking a Medical Director, Clinical Development to lead a late-stage, pivotal program with the potential to expand to additional programs utilizing the same molecule. This role offers the opportunity to lead additional development programs with other assets and manage a small team of clinical scientists and physicians. Reporting to the Senior VP of Clinical Development, you will be responsible for medical monitoring, developing and implementing Clinical Development Plans, including study design, execution, and data interpretation. You will collaborate within a multi-disciplinary team, ensuring clinical and scientific considerations are integrated into development plans. This position involves translational activities, operationalizing studies, real-time data monitoring, proactive issue identification, and medical review for regulatory documents and publications. You will engage with internal stakeholders, management, and external parties including medical experts, regulatory authorities, alliance partners, and vendors.

Responsibilities

• Provides medical monitoring for assigned clinical trials in the field of serious endocrine conditions.
• Leads clinical development programs, integrating extensive knowledge in clinical science and endocrinology with input from global medical and patient communities.
• Collaborates with Medical Directors, Pharmacology, Drug Discovery, external experts, and investigators to build scientific and medical knowledge for clinical development plans.
• Develops a robust Clinical Development Plan (CDP) by integrating scientific rationale, regulatory requirements, product development plans, and patient/shareholder value.
• Ensures the production of high-quality program-related documents, including protocols, Investigator's Brochures (IBs), clinical study reports, briefing documents, and drug labels.
• Establishes and maintains relationships with program counterparts in Research, Regulatory Affairs, Clinical Operations, Statistics, and Contract Research Organizations (CROs).
• Serves as the primary Clinical Development interface for assigned programs with internal stakeholders, external subject matter experts, and alliance partners.
• Contributes to specific Business Development activities and various organizational initiatives within Clinical Development.

Required Qualifications

• MD required.
• Experience with late-stage clinical development and drug development in rare diseases is strongly preferred.
• 4+ years of experience in leading clinical development.

Company Information

Amylyx is a clinical-stage pharmaceutical company based in Cambridge, Massachusetts. Our audacious mission is to develop novel therapies for high unmet needs. We believe in pursuing opportunities with urgency, rigorous science, and an unwavering commitment to the communities we serve. Our culture of caring is powered by our people and guided by our core values: be audacious, be curious, be authentic, be engaged, and be accountable. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait.

Application Instructions

If you share our passion and determination, we encourage you to read the opportunity above and apply.