Medical Director, Clinical Development

Summary

Join Amylyx Pharmaceuticals as a Medical Director, Clinical Development and lead a pivotal late-stage program with potential for expansion. You will be responsible for medical monitoring of clinical trials, developing and implementing the Clinical Development Plan, and interpreting study data. Collaborate with a multidisciplinary team, including research, regulatory affairs, and external stakeholders. The ideal candidate will have an MD, extensive experience in late-stage clinical development, and a proven track record of success in the biotechnology/pharmaceutical industry. This role offers the opportunity to lead additional development programs and contribute to various organizational initiatives. Remote work is supported within the United States, with occasional travel to Cambridge, MA.

Requirements

• MD required
• 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

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

Preferred Qualifications

Experience with late-stage clinical development and drug development in rare diseases strongly preferred

Benefits

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