Senior Medical Director, Clinical Development

amylyx; Cambridge (MA); Remote; USD 280,000 - 420,000; Full time

Job summary

Amylyx seeks a Senior Medical Director, Clinical Development to lead strategic medical direction for late-stage programs. You will shape clinical development plans, oversee studies, and integrate regulatory strategies with portfolio goals.

Reporting to the VP of Clinical Development, you will mentor others, engage with global experts, and drive high-quality trial execution while ensuring patient safety and data integrity.

Qualifications

• MD with residency in a relevant specialty; clinical development experience required.
• Extensive late-stage drug development and biotech/pharma exposure.
• Ability to travel internationally and domestically (≈10%).
• Proven leadership in cross-functional teams and external engagement.

Responsibilities

• Provide strategic medical leadership for late-stage, pivotal programs.
• Lead development of CDPs integrating clinical, regulatory, and commercial needs.
• Design and interpret complex studies, influencing program decisions.
• Collaborate with cross-functional teams to align development plans.
• Mentor medical directors and scientists; ensure patient safety and data integrity.
• Engage with external experts, regulators, and alliance partners.
• Oversee preparation of key program documents and regulatory submissions.

Skills

Medical leadership

Clinical development

Regulatory strategy

Cross-functional collaboration

Stakeholder engagement

Education

MD degree

Residency training

Job description

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

Amylyx is seeking a Senior Medical Director, Clinical Development to provide strategic and scientific leadership for one or more late-stage, pivotal programs with the potential to expand into additional indications and/or programs within the same molecule or across the portfolio. This individual will play a critical role in shaping the overall clinical development strategy and may lead multiple programs or key components of a broader development portfolio. Reporting to the VP of Clinical Development, you will be responsible for leading the design, execution, and interpretation of clinical studies and overseeing the development and implementation of Clinical Development Plans across assigned assets. You will provide strategic input into study design, endpoints, and regulatory strategy, ensuring alignment with the overall program and corporate objectives. The successful candidate will collaborate with cross-functional teams in a matrix environment, influencing stakeholders across Research, Regulatory Affairs, Clinical Operations, and Commercial to ensure that clinical and scientific considerations are fully integrated into development plans. You will proactively identify and mitigate risks, guide decision-making through data-driven insights, and ensure the highest standards of scientific rigor and data integrity. In this role, you will also serve as a key external representative, engaging with global medical experts, investigators, regulatory authorities, and alliance partners. You may lead or mentor a team of clinical scientists and physicians and contribute to broader organizational and portfolio-level initiatives.

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.

Required 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.
• This role requires ability to travel internationally and domestically (approximately 10%).
• Demonstrated ability to collaborate with cross-functional teams and influence without authority in a matrix environment.
• Strong strategic thinking, problem-solving, and decision-making skills.
• Proven ability to interpret complex clinical data and translate insights into actionable strategies.
• Excellent communication and leadership skills, with experience interacting with senior stakeholders and external experts.
• Experience mentoring or leading team members preferred.

Work Location and Conditions

At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska, Arizona, Hawaii, Michigan and Tennessee. You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-