Executive Medical Director

Summit Therapeutics•Princeton, NJ

15h

About The Position

Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. The company is building a team of passionate professionals to drive this mission. Summit's core values include integrity, passion for excellence, purposeful urgency, collaboration, and commitment to people. The team is inspired to touch and help change lives through Summit’s clinical studies in oncology. Summit has multiple global Phase 3 clinical studies in Non-small Cell Lung Cancer (NSCLC) and Colorectal Cancer (CRC) involving ivonescimab, an investigational therapy. Summit is headquartered in Miami, Florida, with additional offices in California, New Jersey, the UK, and Ireland.

Requirements

Board certified or eligible MD with hematology/oncology product development and experience across stages of clinical development.
7+ years’ experience in pharmaceutical, biologics, or biotech R&D environment, or in a research environment involving the collection and analysis of human data in the area of hematology/oncology.
Working knowledge of clinical development pathways for hematology/oncology therapeutics in the US and EMA.
Self-starter who will move forward with key initiatives without being prompted.
Able to perform a myriad of tasks needed to support the clinical development program.
Possesses a highly entrepreneurial and growth mindset.
Works collaboratively with cross-functional teams.
Loves a good mission.

Nice To Haves

Prior experience in a mid-sized, fast-growing pharmaceutical environment is preferred.

Responsibilities

Oversee global Phase 3 clinical trials and BLA (Biologic Licensing Application) filings.
Develop and execute integrated clinical trial programs, 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 advice and decision-making regarding medical input to achieve operational excellence.
Serve as a key medical expert for multiple cross-functional teams, demonstrating effective collaborative skills across various phases of clinical development.
Provide medical insight across functions from discovery to manufacturing.
Engage with investigators, including travel for face-to-face interaction and protocol training.
Serve as a leader on one or multiple potentially pivotal programs.
Apply expertise in the treatment and management of oncology disease to the strategy and clinical development of Summit medicines.
Work cross-functionally with Medical Affairs, Regulatory, Commercial, and other functions to develop the overall product strategy in multiple indications.
Work cross-functionally with Clinical Operations, Biometrics, Pharmacovigilence, and other functions to successfully complete clinical development programs leading to BLA approvals.
Lead teams to execute on clinical development goals (clinical trial execution, clinical development strategy, medical affairs planning).
Manage direct reports or cross-functional team members as needed.
Contribute to the communication strategy of Summit products via publications, manuscripts, abstracts, posters, and scientific presentations.
Make vital contributions on pivotal programs in clinical development.
Direct human clinical trials, Phases 1-3, for lead candidates in development, ensuring all clinical development milestones are met, including enrollment goals.
Participate 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.
Coordinate and develop information for reports submitted to FDA, EMA, PMDA, and government, regulatory, or partner agencies.
Presentations to various external stakeholders - regulators, governing and harmonization bodies, principle investigators, scientific conference attendees, advisors, and opinion leaders.
Provide 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.
Plan, review, and edit Clinical Study Reports.
Plan, review, and edit publications from the program.
Provide input on the design of clinical studies supporting clinical strategy.
Other duties as assigned.