Senior Medical Director

About Summit:

Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.

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)

HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.

HARMONi-3: 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.

HARMONi-7: 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)

HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.

Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.

Overview of Role:

We are seeking a physician to serve as a Senior Medical Director to oversee global Phase 3 clinical trials a BLA (Biologic Licensing Application) filings. The incumbent will be primarily responsible for developing and executing an integrated clinical trial programs including protocol design and medical oversight of new or ongoing studies.   They will be responsible for obtaining 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 are expected.  Additionally, the Medical Director will play a pivotal role in leading 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 multiple potentially pivotal programs.

Role and Responsibilities:

Significant Oncology Experience 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 various exter…