Medical Director, Clinical Development

Amylyx is a clinical-stage pharmaceutical company based in Cambridge, Massachusetts, with an audacious mission to develop novel therapies for high unmet needs. We are currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, progressive supranuclear palsy (PSP), and amyotrophic lateral sclerosis (ALS). Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve.

Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – create 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 determination, we encourage you to read the opportunity below and apply.

THE OPPORTUNITY

Amylyx is seeking a Medical Director, Clinical Development to be the lead for a late-stage, pivotal program that has the potential to expand to additional programs with the same molecule.  This program may be the first of several for this molecule given the mechanism of action of the drug. Opportunities to lead additional development programs with other assets also may arise, together with leading a small team of clinical scientists and physicians. Reporting to the Senior VP of Clinical Development, you will be responsible for medical monitoring for assigned clinical trials, the development and implementation of the Clinical Development Plan for the assigned assets, including clinical study design and execution, as well as interpretation of study data. The successful candidate will interact within a multi-disciplinary, matrix work group including research, ensuring that clinical and scientific issues are appropriately considered in the development and execution of individual clinical studies and overall clinical development plans. You will be involved in potential translational activities, operationalizing studies, monitoring data in real time to ensure the integrity of the study, proactively identifying issues in the conduct of trials, and in medical review and analysis of data for the purposes of both data cleaning and interpretation for regulatory documents and publications. In this role you will interact with multiple functions and management within Amylyx, and with external stakeholders including the global medical expert community, global regulatory authorities, alliance partners and vendors.

THE RESPONSIBILITIES

• Provides medical monitoring to assigned clinical trials in the arenas of serious endocrine conditions.
• Provides clinical development leadership for programs that integrate extensive knowledge in clinical science and endocrinology, and inputs from the global medical and patient communities.
• Works closely with Medical Directors, Pharmacology, Drug Discovery, external experts, and investigators to accumulate scientific and medical knowledge necessary to support clinical development plans.
• Integrates scientific rationale, regulatory requirements, product development plan, and value to patients and shareholders to build a solid Clinical Development Plan (CDP).
• Accountable for production of highest quality program related documents, including protocols, IBs, clinical study reports, briefing documents and drug labels.
• Develops and maintains relationships with program counterparts in Research, Regulatory Affairs, Clinical Operations, Statistics and Contract Research Organizations (CROs).
• Acts as the primary Clinical Development interface with internal stake holders as well as external subject matter experts and alliance partners for the assigned programs.
• Contributes to specific Business Development activities and various organizational initiatives in Clinical Development.

REQUIRED QUALIFICATIONS

• MD required
• Experience with late-stage clinical development and drug development in rare diseases strongly preferred
• 4+ years of experience in leading clinical development programs in the biotechnology/pharmaceutical industry with a proven record of achievements.
• Ability to think critically and demonstrate troubleshooting and problem-solving skills.
• Demonstrated leadership and team building skills as well as the ability to perform effectively in a multi-disciplinary environment.
• Ability to lead directly and by influence, including strong interpersonal, problem solving, conflict resolution and analytical skills in a matrix environment.
• Excellent communication skills (oral and written) and organizational skills.
• Ability to travel internationally and domestically

WORK LOCATION AND CONDITIONS

• At Amylyx, we proudly support remote work opportunities within the United States. Howeve