Executive Medical Director

Summit Therapeutics•Princeton, NJ

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. We are seeking a physician to serve as a 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 integrated clinical trial programs, including protocol design and medical oversight of new or ongoing studies. This role involves obtaining scientific advisory input, working with biostatisticians for Phase 3 design and analyses, supporting regulatory interactions for product advancement, and collaborating closely with clinical operations to provide medical input for operational excellence. The candidate must possess demonstrated effective collaborative skills to work across various phases of clinical development and serve as a key medical expert for multiple cross-functional teams. Medical insight across functions from discovery to manufacturing is expected. Investigator engagement, including travel for face-to-face interaction and protocol training, is a vital component of this role. Prior experience in a mid-sized, fast-growing pharmaceutical environment is preferred, as this role will be working on product development in an extremely fast-paced and intense environment. The Medical Director will serve as a leader on one or multiple potentially pivotal programs.

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

Significant Oncology Experience: Expertise in the treatment and management of oncology disease to be applied to the strategy and clinical development of Summit medicines to benefit patients.
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 based on team needs.
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 programs.
Direct human clinical trials, Phases 1-3, for lead candidates in development, helping to ensure 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, principal investigators, scientific conference attendees, advisors, and opinion leaders.
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.
Planning, reviewing, and editing Clinical Study Reports.
Planning, reviewing, and editing publications from the program.
Providing input on the design of clinical studies supporting clinical strategy.
Other duties as assigned.