Executive Director, Oncology Early Clinical Development Lead

Position Summary

GSK Oncology Clinical Development is seeking a highly skilled and motivated Executive Director, Oncology Early Clinical Development Lead to join our dynamic Oncology Research and Development team. In this role the successful candidate will create a strong link between Clinical Development and Pre‑clinical/Discovery teams to improve forward and reverse translation and, thereby, increase the success of our Oncology clinical portfolio. They will be responsible for leading a team of talented Oncology Early Clinical Development Medical Directors and Clinical Scientists who will design and execute early‑phase clinical studies, as well as contribute to the translational research strategy for early phase clinical assets.

This role offers a unique opportunity to bridge the gap between preclinical research and clinical development, ensuring the successful translation of innovative therapies from the lab to the clinic.

Please note:

This position requires an on‑site office‑based presence 2 to 3 days a week in the US (Upper Providence, PA. or Waltham, MA.); UK (London or Stevenage);
Switzerland (Zug) or Poland (Warsaw).

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Accountable for the clinical development plans (CDPs) for a portfolio of early phase (Phase I/II) clinical study protocols, including first‑in‑human (FIH) trials, dose‑escalation studies, and proof‑of‑concept (POC) studies.
• Accountable for overall benefit: risk of a clinical program. If not a physician, the CDL is expected to delegate to and interface closely with the appropriate physician(s) on the program.
• Accountable for driving the end‑to‑end clinical development strategy and alignment to target medicine profiles (TMP) and integrated evidence plans (IEP), spanning all phases of development, including trial design, execution, and interpretation and delivery of trial results.
• Lead clinical development discussions and teams at regulatory interactions and be accountable for drafting clinical components of regulatory submissions/files (i.e. IND, NDA, BLA, MAA) including briefing documents, presentations, addressing questions and responses.
• Participate as a core member of the Medicine Development Team (MDT) or Early Development Team (EDT) and provide a single Clinical Development accountability at the program level within these teams and other cross‑functional partnerships with Medical Affairs, Integrated Evidence, Publications, and Global and Regional Commercial functions.
• Ensure that all clinical studies are conducted in compliance with applicable regulatory requirements, Good Clinical Practice (GCP) guidelines, and GSK policies and procedures.
• Lead the cross‑functional Clinical Matrix Team and provide clinical leadership, Oncology Clinical Development expertise, and customer insight for the program.

• Oversee the development and execution of the clinical development components of the overall translational science strategy in partnership with Oncology Early Development Leaders, Oncology Translational Science, pre‑clinical Oncology Research teams (ETCT & ITCT), AI/ML, Clinical Pharmacology & Experimental Medicine, Research Technologies.
• Partner with the Oncology Tumor Teams (OTTs) to develop the translational strategy across assets within a given tumor and drive OTT activities with a clinical and translational focus.
• Drive advancements in translational research and emerging technologies to improve study designs and foster innovation.

• Interpret complex translational and clinical data and identify trends for clinical and regulatory documents consult on safety analyses, and responses to health authority queries.
• Author and/or review abstracts, presentations and manuscripts for accuracy of clinical data, interpretation, and content.
• Prepare for governance discussions in close collaboration with cross‑functional Early Development or Medicine Development Team and other business lines.
• Lead preparation of clinical sections of relevant regulatory filings (IND, study reports,…