[Hiring] Senior Medical Director @Summit Therapeutics

Role Description

We are seeking a physician to serve as a Senior Medical Director to oversee global Phase 3 clinical trials and BLA (Biologic Licensing Application) filings. The incumbent will be primarily responsible for developing and executing an integrated clinical trial program, including protocol design and medical oversight of new or ongoing studies.

• Obtain scientific advisory input.
• Work with biostatisticians for Phase 3 design and analyses.
• Support regulatory interactions for product advancement.
• Work closely with clinical operations to provide medical input for operational excellence.
• Demonstrate effective collaborative skills across various phases of clinical development.
• Serve as a key medical expert for multiple cross-functional teams.
• Provide medical insight across functions from discovery to manufacturing.
• Lead investigator engagements, including travel for face-to-face interaction and protocol training.
• Prior experience in a mid-sized, fast-growing pharmaceutical environment is preferred.
• Serve as a leader on multiple potentially pivotal programs.

Qualifications

• Board certified or eligible MD with hematology/oncology product development experience.
• Minimum of 5+ years’ experience in pharmaceutical, biologics, or biotech R&D environment.
• Working knowledge of clinical development pathways for hematology/oncology therapeutics in the US and EMA.
• Self-starter with a highly entrepreneurial and growth mindset.
• Able to perform a myriad of tasks needed to support the clinical development program.
• Collaborative with cross-functional teams.

Requirements

• Significant oncology experience to apply knowledge to strategy and clinical development.
• Work cross-functionally with Medical Affairs, Regulatory, Commercial, and other functions.
• Lead teams to execute on clinical development goals.
• Manage direct reports or cross-functional team members as needed.
• Contribute to the communication strategy of Summit products via publications and presentations.
• Direct human clinical trials, phases 1-3, ensuring all clinical development milestones are met.
• Participate in medical review of adverse event reports and safety data monitoring.
• Coordinate and develop information for reports submitted to regulatory agencies.
• Presentations to various external stakeholders.
• Knowledge of clinical trial conduct to support operational needs.
• Plan, review, and edit Clinical Study Reports and publications.
• Provide input on the design of clinical studies supporting clinical strategy.
• All other duties as assigned.

Benefits

• Pay Transparency: $253,000 — $317,000 USD.
• Actual compensation packages based on unique candidate factors.
• Total compensation may include bonus, stock, benefits, and/or other variable compensation.