Senior Medical Director, Clinical Development

Summary

Join Amylyx, a clinical-stage pharmaceutical company, as a Senior Medical Director, Clinical Development. Lead a pivotal Phase 3 program with potential expansion to additional programs using the same molecule. This role involves medical monitoring for clinical trials, developing and implementing clinical development plans, and interpreting study data. You will collaborate with a multi-disciplinary team, interact with external stakeholders, and contribute to various organizational initiatives. The position offers a remote-friendly work environment within the United States, with occasional travel to the Cambridge, MA office required. Amylyx values a culture of caring and provides opportunities for professional growth.

Requirements

• MD required
• 8+ 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

• Provide medical monitoring to assigned clinical trials in the arenas of serious and fatal neurodegenerative diseases and endocrine conditions
• Provide clinical development leadership for programs that integrate extensive knowledge in clinical science and neurology or endocrinology, and inputs from the global medical and patient communities
• Work closely with Medical Directors, Pharmacology, Drug Discovery, external experts, and investigators to accumulate scientific and medical knowledge necessary to support clinical development plans
• Integrate scientific rationale, regulatory requirements, product development plan, and value to patients and shareholders to build a solid Clinical Development Plan (CDP)
• Be accountable for production of highest quality program related documents, including protocols, IBs, clinical study reports, briefing documents and drug labels
• Develop and maintain relationships with program counterparts in Research, Regulatory Affairs, Clinical Operations, Statistics and Contract Research Organizations (CROs)
• Act as the primary Clinical Development interface with internal stake holders as well as external subject matter experts and alliance partners for the assigned programs
• Contribute 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

Benefits

• This is a remote friendly role, but you must reside and work within the United States, and in a state where Amylyx currently does business, to be considered
• Any change in your remote location must be approved by Amylyx