Associate Director, Data Generation

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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.

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

The Associate Director, Global Data Generation will play a critical role in driving the strategy, planning, and execution of data generation initiatives to support development and commercialization. This position will support the management of all non-sponsored research collaborations, including investigator-sponsored trials (ISTs), global Cooperative Group trials, non-sponsored registrational trials, as well as real-world evidence studies, ensuring alignment with Summit’s overall clinical and scientific strategic objectives.

The Associate Director will collaborate cross-functionally with medical, clinical, regulatory, CMC/drug supply, biostatistics, PV/safety, and the research teams to generate high-quality evidence that informs product value, enhances scientific understanding, and supports publication and regulatory strategies. The ideal candidate will bring a strong background in oncology research, project management, and stakeholder engagement, with demonstrated experience managing complex research programs in a fast-paced, innovative environment.

Role and Responsibilities

• Independently oversee all operational aspects of non-sponsored research studies, delivering comprehensive end-to-end management. Responsibilities include planning discussions, protocol development, site coordination, document management, contract execution, fair market value evaluations, drug shipments, and oversight of project budgets and execution to ensure timelines and team goals are met.

• Responsible for identifying key data gaps and developing strategies to address them through innovative research approaches. This includes proactively engaging with both internal and external stakeholders to assess emerging scientific trends and opportunities that may impact the Company’s research program.

• This role requires a forward-thinking mindset to anticipate future evidence needs and to ensure that data generation activities are both comprehensive and strategically aligned with clinical, regulatory and commercial objectives.

• Develop metrics and…