Medical Director

The Medical Director will lead clinical development strategy and operations for active programs in a biotech company, working closely with cross-functional teams and external stakeholders.

Location: United States

Responsibilities

• Lead the development of study protocols, statistical analysis plans, investigators brochures, and other key study documents.
• Prepare clinical development plans with support from cross functional team members.
• Perform regular data reviews (including PK, safety, efficacy).
• Provide leadership on cross-functional study teams for assigned trials.
• Participate in the preparation of regulatory documents including INDs, CTAs, safety reports, and responses to regulatory authorities.
• Communicate with and inspire external stakeholders such as investigators and medical community.
• Prepare and present abstracts/oral presentations at conferences, and write manuscripts.
• Provide medical insight to Advisory Board meetings and develop learning materials.
• Present clinical data at relevant advisory board meetings and scientific meetings.

Requirements

• MD or equivalent.
• ABIM board certification/eligibility in oncology, nuclear medicine, or radiation oncology is highly desired.
• Experience leading oncology early clinical development programs.
• Experience working with discovery, preclinical, translational, and external collaborators.
• Interest and understanding of radiopharmaceuticals.
• Hands-on pharmaceutical or biotech experience in oncology and/or radiopharmaceutical clinical development.
• Experience leading clinical development teams and Phase 1 and 2 trials within radiopharmaceutical space.