Executive Medical Director

Responsibilities

• Oversee global Phase 3 clinical trials and BLA filings
• Develop and execute integrated clinical trial programs including protocol design
• Work cross-functionally with Medical Affairs, Regulatory, Commercial, and Clinical Operations
• Lead teams to execute clinical development goals and medical affairs planning
• Contribute to communication strategies via publications, manuscripts, and scientific presentations
• Direct human clinical trials (Phases 1-3) and ensure enrollment goals are met
• Participate in medical review of adverse event reports and safety data monitoring
• Coordinate and develop information for reports submitted to FDA, EMA, and PMDA
• Present to external stakeholders including regulators and principle investigators

Requirements

• Board certified or eligible MD with hematology/oncology experience
• 7+ years of experience in pharmaceutical, biologics, or biotech R&D
• Working knowledge of clinical development pathways for hematology/oncology in the US and EMA
• Experience in product development across various stages of clinical development

About the Company

Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life and resolving serious unmet medical needs through clinical studies in oncology.