Principal Scientist, Biomarker

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:

The Senior Scientist/Principal scientist, Biomarker is responsible for end-to-end operational delivery of biomarker activities in clinical trials, ensuring high-quality biospecimen and biomarker data are generated on time, within budget, and in compliance with regulatory and ethical standards. The role bridges science and clinical operations, working closely with biomarker scientists, clinical operations, CROs, and central/specialty labs to implement biomarker strategies at a global scale.

Role and Responsibility:

• Take ownership of the operational plan for clinical biomarkers across designated studies.
• Ensure alignment of sample collection, processing, shipment, storage, and analysis activities with protocol specifications and trial timelines.
• Contribute to the development of biomarker-specific sections within protocols, laboratory manuals, informed consent forms (ICFs), electronic case report forms (eCRFs), and data transfer specifications.
• Develop and maintain comprehensive instructions for sample handling, kit requirements, and shipping procedures.
• Oversee outsourced biomarker assay projects from initiation through to data delivery, managing timelines, quality standards, and regulatory compliance.
• Monitor project performance, proactively resolve operational issues, and escalate risks as necessary.
• Ensure prompt shipment of specimens to laboratories or biorepositories and manage appropriate storage or destruction of samples per protocol and regulatory guidelines.
• Coordinate timely and accurate data transfers into clinical databases, reconciling discrepancies with laboratories and data management teams.
• Act as the primary operational point of contact for biomarker-related matters within clinical study teams.
• Collaborate with biomarker scientists to ensure that scientific strategies are feasible and correctly implemented from an operational perspective.
• Provide regular updates on biomarker operations, including status reports, identified risks, and corresponding mitigation plans, to study and governance teams.
• Oversee end-to-end implementation of biomarkers in clinical trials, including the creat