Executive Director, Oncology Early Clinical Development Lead

Role 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. The role will create a strong link between Clinical Development and Pre-clinical/Discovery teams to improve forward and reverse translation and increase the success of the Oncology clinical portfolio. The successful candidate will lead a team of 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 assets. This position bridges preclinical research and clinical development to translate innovative therapies from the lab to the clinic.

Responsibilities

• Clinical Study Design & Execution:
  • Accountable for the clinical development plans (CDPs) for a portfolio of early phase (Phase I/II) protocols, including FIH trials, dose-escalation, and POC studies.
  • Accountable for overall benefit: risk of a clinical program; delegate to appropriate physicians as needed.
  • Drive end-to-end clinical development strategy aligned to TMP and IEP across all phases, including trial design, execution, interpretation, and delivery of results.
  • Lead clinical development discussions at regulatory interactions; draft clinical components of regulatory submissions (IND, NDA, BLA, MAA) including briefing documents and responses.
  • Participate as a core member of MDT or EDT; provide single Clinical Development accountability at the program level within cross-functional partnerships.
  • Ensure all studies are conducted in compliance with regulatory requirements, GCP, and GSK policies.
  • Lead the cross-functional Clinical Matrix Team and provide clinical leadership, Oncology Clinical Development expertise, and customer insight for the program.
• Translational Research Strategy:
  • Oversee development and execution of clinical development components of translational science strategy in partnership with various Oncology leaders and discovery/ETCT ITCT teams, AI/ML, and Clinical Pharmacology.
  • Partner with Oncology Tumor Teams to develop translational strategy across assets within a tumor and drive OTT activities with clinical focus.
  • Drive advancements in translational research and emerging technologies to improve study designs and foster innovation.
• Data Analysis and Interpretation:
  • Interpret complex translational and clinical data; identify trends for clinical/regulatory documents; consult on safety analyses and responses to health authority queries.
  • Author/review abstracts, presentations, and manuscripts; ensure accuracy of clinical data and interpretation.
  • Prepare for governance discussions with cross-functional teams; lead preparation of clinical sections of regulatory filings.
  • Lead and provide clinical support for investigator and consultant meetings; present study results to internal/external stakeholders.
• Collaboration and Communication:
  • Integrate inputs from across disciplines to ensure alignment and successful execution of translational research initiatives.
  • Build relationships with external experts, academic collaborators, and research organizations; collaborate with investigators and steering committees on publications.
  • Serve as program medical expert for internal and external collaborators, investigators, and consultants.
• Oncology Clinical Development Leadership:
  • Lead, coach, and mentor a team of Oncology Early Clinical Development Medical Directors and Clinical Scientists; conduct regular staff meetings and 1:1s.
  • Guide direct reports to ensure cross-functional integration and alignment for CDP and translational strategy execution.
  • Foster a culture within the team: bold, swift, and integrity-driven as a One Oncology community.
  • Contribute to standards for clinical documents and data review processes across Oncology Clinical Development.

Qualifications

• Required: Advanced degree (PhD/PharmD).
• Clinical and Research Experience in Oncology.
• Pharmaceutical or relevant scientific/medical/clinical experience in Oncology with focus on designing and executing early-phase trials (FIH, POC) and translational research.
• Experience with Oncology treatment guidelines, clinical development process, and drug approval processes in major regions.
• Prior experience developing and driving translational strategy (biomarker, companion diagnostic, PK/PD modeling and simulation).

Preferred Qualifications

• MD preferred.
• Board certification/eligibility or clinical experience in Oncology.
• Experience in GI therapeutic area highly preferred.
• In-depth knowledge of medical aspects of GCP, ICH, FDA, EMEA, NICE and other guidelines/regulations.
• Broad experience in data analysis, interpretation, and clinical relevance (e.g., ISS, ISE, competitor data).
• Experience leading matrix teams with a track record of high performance.
• Strong business acumen; effective communication skills; ability to present complex data to all levels.
• Demonstrated ability to produce written scientific communications with clarity and rigor, compliant with control documents.
• Decision-making and problem-resolution capabilities in critical situations; ability to adapt to changing environment.
• Ability to engage in Oncology Clinical Development culture and broader GSK environment with professionalism.
• Understanding of adverse effects detection, investigation, assessment, and prevention.
• Highly developed negotiating and influencing skills.

Additional Requirements

• If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary ranges from $242,550 to $404,250. If in another US location, range is $220,500 to $367,500.
• 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).
• Travel expectations are not specified beyond the on-site requirement.