Strategic Senior Medical Director, Clinical Development

Amylyx Pharmaceuticals, Inc.; Cambridge (MA); Remote; USD 340,000 - 368,000; Full time

Job summary

Amylyx Pharmaceuticals, Inc. is seeking a Senior Medical Director, Clinical Development to provide strategic and scientific leadership for late-stage, pivotal programs with potential expansion to additional indications.

The role involves shaping clinical development strategy and overseeing study design, regulatory strategy, and program execution. Reporting to the VP of Clinical Development, you will mentor clinical scientists, collaborate across Research, Regulatory, Clinical Operations, and

Qualifications

• MD and Residency Experience required.
• Significant experience in late-stage clinical development and drug development in biotech/pharmaceutical industry; neurology, endocrinology, or rare disease experience strongly preferred.
• Willingness and ability to travel internationally and domestically (approximately 10%).
• Ability to collaborate with cross-functional teams and influence in a matrix environment.
• Strong strategic thinking, problem-solving, and decision-making skills.
• Excellent communication and leadership skills, with experience interacting with senior stakeholders and external experts.

Responsibilities

• Provides strategic medical leadership and oversight for assigned clinical programs, including late-stage and pivotal trials.
• Leads development and execution of Clinical Development Plans (CDPs), integrating clinical, scientific, regulatory, and commercial considerations.
• Drives study design, protocol development, and interpretation of complex clinical data to inform key program decisions.
• Serves as a core member of cross-functional program teams, influencing strategy and ensuring alignment across disciplines.
• Provides senior-level medical monitoring and guidance, ensuring patient safety, data integrity, and high-quality trial execution.
• Leads interactions with external stakeholders including key opinion leaders, investigators, regulatory agencies, and alliance partners.
• Oversees preparation of key program documents including protocols, investigator brochures, clinical study reports, regulatory submissions, and publications.
• Mentors and provides scientific guidance to junior team members, including Medical Directors and Clinical Scientists.
• Identifies and implements process improvements and best practices within Clinical Development.

Skills

Strategic thinking

Data interpretation

Cross-functional collaboration

Communication & leadership

Mentoring or leading team members

Education

MD and Residency Experience

Job description

Amylyx Pharmaceuticals, Inc. is seeking a Senior Medical Director, Clinical Development to provide strategic and scientific leadership for late-stage, pivotal programs with potential expansion to additional indications.

The role involves shaping clinical development strategy and overseeing study design, regulatory strategy, and program execution. Reporting to the VP of Clinical Development, you will mentor clinical scientists, collaborate across Research, Regulatory, Clinical Operations, and