Medical Director

Overview

Join to apply for the Medical Director role at Summit Therapeutics, Inc. Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining immunotherapy via a blockade of PD-1 with anti-angiogenesis by blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when both PD-1 and VEGF are present. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials : HARMONi, HARMONi-3 and HARMONi-7.

Ivonescimab is an investigational therapy that is not approved by regulatory authorities in Summit’s license territories, including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting.

Role Overview

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. They will obtain scientific advisory input, work with biostatisticians for phase 3 design and analyses, support regulatory interactions for product advancement, and work closely with clinical operations to provide advice and decision making regarding medical input to achieve operational excellence. The candidate must have demonstrated effective collaborative skills to work across various phases of clinical development and serve as a key medical expert for multiple cross functional teams. This position will provide medical insight across a myriad of functions from discovery to manufacturing and investigator engagements including travel to support face-to-face interaction and protocol training. 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.

Responsibilities

• The role will require expertise in the treatment and management of oncology disease such that knowledge can 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, Pharmacovigilance, 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.
• Making vital contributions on pivotal programs in clinical development program.
• Directing human clinical trials, phases 1-3, for lead candidate in development, helping to ensure all clinical development milestones are met including enrollment goals.
• 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.
• Coordinate and develop information for reports submitted to FDA, EMA, PMDA, and government, regulatory, or partner agencies.
• Presentations to 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.
• All other duties as assigned.

Experience, Education And Specialized Knowledge And Skills

Pay range for this role is $230,000 - $270,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including skill set, depth of experience, certifications, and location. The total compensation package may also include bonus, stock, benefits and / or other applicable variable compensation.

Seniority level : Director.

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