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Amylyx Pharmaceuticals · 5 months ago

Medical Director, Clinical Development

United States

Full-time

Remote

Mid, Senior Level

4+ years exp

Amylyx is a clinical-stage pharmaceutical company dedicated to developing novel therapies for high unmet needs. They are seeking a Medical Director, Clinical Development to lead pivotal programs and oversee clinical trials, ensuring the integrity of studies and collaboration with various stakeholders. The role involves medical monitoring, clinical development leadership, and interaction with global medical experts and regulatory authorities.

BiotechnologyMedicalNeurosciencePharmaceutical

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

Qualification

MDClinical development leadershipDrug development in rare diseasesTeam building skillsAnalytical skillsInterpersonal skillsProblem-solving skillsCommunication skillsOrganizational skills

Required

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