Summit Therapeutics
Senior Medical Director
Remote (US) · Director
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About the role
- Will be primarily responsible for medical affairs and clinical development including medical oversight of clinical studies.
- Medical insight across a myriad of functions from discovery to manufacturing is expected.
- The Medical Director will work on multiple potentially pivotal programs.
Responsibilities
- Directing human clinical trials, phases 1-3, for lead candidate in development, helping to ensure all clinical development milestones are met including enrollment goals.
- Coordinate and develop information for reports submitted to FDA, EMA, PMDA, and government, regulatory, or partner agencies.
- Knowledge of clinical trial conduct to support operational needs for planning and executing clinical trials, including adherence to protocols, safety reviews, assay development, training, and clinical document review.
Nice to have
- Summit's core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people.
- Summit's team is inspired to touch and help change lives through Summit's clinical studies in the field of oncology.
- Summit has multiple global Phase 3 clinical studies, including:
- Non-small Cell Lung Cancer (NSCLC)
- Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.
- Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.
- Colorectal Cancer (CRC)
- Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.
Benefits
- Work cross functionally with Medical Affairs, Regulatory, Commercial and other functions to develop the overall product strategy in multiple indications.
- Lead teams to execute on clinical development goals (clinical trial execution, clinical development strategy, medical affairs planning).
- Participating in medical review of adverse event reports and monitoring of incoming safety data in conjunction with product safety/pharmacovigilance, including evaluating and escalating safety signals.
Company info
- Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.
This listing is sourced directly from Summit Therapeutics's careers page and normalized into a canonical job model.