Senior Medical Director

Summit Therapeutics

28d•$237,000 - $296,000

About The Position

Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life, extending life, and addressing serious unmet medical needs. The company is advancing multiple global Phase 3 clinical studies in non-small cell lung cancer and colorectal cancer. Ivonescimab is investigational and is not approved by regulatory authorities other than China’s National Medical Products Administration (NMPA). The Senior Medical Director will primarily support medical affairs and clinical development, including medical oversight of clinical studies. The role will obtain scientific advisory input, work with external clinical investigators, support regulatory interactions, and advise and make decisions with Clinical Operations to help achieve operational excellence. The director will serve as a key medical expert across cross-functional teams and contribute medical insight across functions from discovery through manufacturing. Investigator engagement, including travel for in-person interaction and protocol training, is an important part of the role. The position supports multiple potentially pivotal programs in a fast-paced environment. The role requires substantial oncology expertise to guide the strategy and clinical development of Summit medicines. The Senior Medical Director will contribute to product strategy, lead teams toward clinical development goals, direct human clinical trials, contribute to regulatory submissions and external presentations, and support safety review, clinical study reporting, and scientific communications.

Requirements

Board-certified or board-eligible MD.
Hematology/oncology product development experience across stages of clinical development.
At least 5 years of experience in pharmaceutical, biologics, or biotech R&D, or in a research environment involving collection and analysis of human data in hematology/oncology.
Working knowledge of clinical development pathways for hematology/oncology therapeutics in the United States and EMA.
Fluent in English and at least one additional European language, such as French, Spanish, German, or Italian.
Proficient with standard Microsoft Office applications, such as Word and Excel.
Strong computer and database skills.
Attention to detail, accuracy, and confidentiality.
Clear and concise oral and written communication skills, including the ability to explain complex ideas understandably.
Excellent organizational skills, critical thinking, problem-solving, and ability to work independently.
Ability to multitask, manage time-sensitive and highly confidential documents, and prioritize conflicting demands.
Ability to work in a fast-paced, demanding, collaborative environment and move key initiatives forward independently.

Nice To Haves

Experience using electronic document management systems and document review tools.
Prior experience in a mid-sized, fast-growing pharmaceutical environment.

Responsibilities

Provide medical oversight of clinical studies and contribute to medical affairs and clinical development.
Obtain scientific advisory input and work with external clinical investigators, including travel for in-person engagement and protocol training.
Support regulatory interactions to advance products and coordinate information for reports submitted to the FDA, EMA, PMDA, and government, regulatory, or partner agencies.
Advise and make decisions with Clinical Operations on medical matters to support operational excellence.
Work cross-functionally with Medical Affairs, Regulatory, Commercial, Clinical Operations, Biometrics, Pharmacovigilance, and other functions on product strategy and clinical development.
Lead teams in executing clinical development goals, including clinical trial execution, clinical development strategy, and medical affairs planning.
Make vital contributions to two or more pivotal clinical development programs.
Direct Phase 1–3 human clinical trials and help ensure clinical development milestones, including enrollment goals, are met.
Participate in medical review of adverse event reports and monitoring of safety data with Product Safety/Pharmacovigilance, including evaluating and escalating safety signals.
Contribute to product communication through publications, manuscripts, abstracts, posters, and scientific presentations.
Present to external stakeholders, including regulators, governing and harmonization bodies, principal investigators, scientific conference attendees, advisors, and opinion leaders.
Apply knowledge of clinical trial conduct to planning and execution, including protocol adherence, safety reviews, assay development, training, and clinical document review.
Plan, review, and edit Clinical Study Reports and program publications.
Provide input on clinical study design in support of clinical strategy.
Perform other duties as assigned.