Senior Medical Director

Summit Therapeutics Inc.; United States; Remote; USD 250,000 - 450,000; Full time

Job summary

Summit Therapeutics Inc. is seeking an MD with hematology/oncology expertise to oversee global Phase 3 trials and regulatory filings.

The role involves leading integrated clinical development programs, medical oversight, and cross-functional collaboration with Medical Affairs, Regulatory, Commercial, and Clinical Operations. The candidate will direct studies (Phases 1-3), review safety data, contribute to publications, and present findings to regulators and investigators.

Qualifications

• MD board certified or eligible with hematology/oncology expertise.
• 5+ years in pharma, biologics, or biotech R&D.
• Experience in hematology/oncology clinical development stages.
• Working knowledge of US and EMA development pathways.

Responsibilities

• Oversee global Phase 3 trials and BLA filings.
• Develop and execute integrated clinical trial programs including protocol design.
• Provide medical oversight for new and ongoing studies.
• 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.
• Coordinate information for reports submitted to FDA, EMA, and PMDA.
• Present to external stakeholders including regulators and principal investigators.

Education

MD board-certified or eligible in hematology/oncology

Job description

Responsibilities

• Oversee global Phase 3 clinical trials and BLA filings
• Develop and execute integrated clinical trial programs including protocol design
• Provide medical oversight for new and ongoing studies
• 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
• Coordinate information for reports submitted to FDA, EMA, and PMDA
• Present to external stakeholders including regulators and principal investigators

Requirements

• Board certified or eligible MD with hematology/oncology expertise
• 5+ years of experience in pharmaceutical, biologics, or biotech R&D
• Experience in clinical development stages for hematology/oncology
• Working knowledge of US and EMA clinical development pathways
• Strong collaborative and entrepreneurial mindset

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.