Executive Director, Oncology Early Clinical Development Lead

Executive Director, Oncology Early Clinical Development Lead

Apply for the Executive Director, Oncology Early Clinical Development Lead position at GSK
.

Site: United States (Upper Providence, PA; Waltham, MA), United Kingdom (London, Stevenage), Switzerland (Zug), Poland (Warsaw)

Posted Date: Dec 5 2025.
On‑site presence: 2–3 days a week at any of the listed locations.

GSK Oncology Clinical Development seeks a highly qualified Executive Director to bridge pre‑clinical research and clinical development, leading a team of Oncology Early Clinical Development Medical Directors and Clinical Scientists. The role enhances translational research strategy, drives early‑phase clinical study design, and ensures regulatory compliance across the portfolio.

• Accountable for the clinical development plans (CDPs) for early‑phase (Phase I/II) protocols, including first‑in‑human trials, dose‑escalation studies, and proof‑of‑concept studies.
• Oversee benefit: risk analyses for clinical programs and delegate to physician leadership as needed.
• Drive end‑to‑end clinical development strategy, aligning to target medicine profiles (TMP) and integrated evidence plans (IEP).
• Lead discussions with regulatory bodies and draft clinical components of submissions (IND, NDA, BLA, MAA).
• Act as the single Clinical Development accountability point within Medicine Development/ Early Development Teams and cross‑functional partnerships.
• Ensure compliance with regulatory requirements, Good Clinical Practice (GCP) guidelines, and GSK policies.
• Lead the cross‑functional Clinical Matrix Team and provide oncology expertise and customer insight.

• Oversee clinical components of the translational science strategy in partnership with Oncology Early Development Leaders and translational science teams.
• Partner with Oncology Tumor Teams (OTTs) to develop translational strategies across assets, driving OTT activities.
• Advance translational research and emerging technologies to improve study designs and foster innovation.

• Interpret complex translational and clinical data, consult on safety analyses, and respond to health authority queries.
• Author and review abstracts, presentations, and manuscripts for accuracy.
• Prepare for governance discussions with cross‑functional teams.
• Lead preparation of clinical sections for regulatory filings (IND, study reports, NDA, annual reports).
• Provide clinical support for investigator and consultant meetings.
• Present study results and translational insights to stakeholders.

• Integrate inputs from research, clinical, medical, scientific, commercial, regulatory, manufacturing, and operations disciplines.
• Build and maintain relationships with external experts, academic collaborators, and research organizations.
• Collaborate with Principal Investigators and Steering Committees on publications linked to clinical data.
• Serve as program medical expert for internal and external collaborators, investigators, and consultants.

• Lead, coach, and mentor a team of Oncology Early Clinical Development Medical Directors and Clinical Scientists.
• Guide direct reports toward cross‑functional integration and alignment.
• Promote a culture of boldness, speed, integrity, and One Oncology community.
• Establish standards for clinical documents and data review processes across Oncology Clinical Development.

This role offers a unique opportunity to impact the translation of innovative therapies from laboratory to clinic, while shaping early clinical development in a collaborative environment.

• Advanced degree required (PhD/Pharm
  
  D).
• Clinical and research experience in oncology.
• Experience designing and executing early‑phase clinical trials, including FTIH and POC.
• Knowledge of oncology treatment guidelines and drug approval processes in major regions.
• Prior experience developing translational strategy: biomarker, companion diagnostic, PK/PD modeling and simulation.

• MD preferred.
• Board certification/eligibility or clinical…