Executive Director, Oncology Early Clinical Development Lead

Executive Director, Oncology Early Clinical Development Lead

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting‑edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, focusing on accelerating significant assets that meet patients’ needs and have the highest probability of success.

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 and contribute to the translational research strategy for early phase clinical assets.

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).

• 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 studies.
• Accountable for overall benefit‑risk of a clinical program, delegating to and working closely with the appropriate physician(s) when not a physician.
• Drive 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, 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 (IND, NDA, BLA, MAA) including briefing documents and presentations.
• Participate as a core member of the Medicine Development Team (MDT) or Early Development Team (EDT) and provide single Clinical Development accountability at the program level within cross‑functional partnerships.
• Ensure all clinical studies comply with applicable regulatory requirements, Good Clinical Practice (GCP) guidelines and GSK policies.
• 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 clinical development components of the overall translational science strategy in partnership with Oncology Early Development Leaders, Oncology Translational Science, pre‑clinical teams, AI/ML, Clinical Pharmacology & Experimental Medicine and Research Technologies.
• Partner with Oncology Tumor Teams (OTTs) to develop translational strategy across assets within a given tumour 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, identify trends, consult on safety analyses and respond 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 teams and business lines.
• Lead preparation of clinical sections of regulatory filings (IND, study reports, NDA, annual reports).
• Provide clinical support for investigator and consultant meetings.
• Present study results and translational insights to internal and external stakeholders, including senior…