Executive Director, Oncology Early Clinical Development Lead

Role Summary

Executive Director, Oncology Early Clinical Development Lead, bridging Clinical Development with Pre-clinical/Discovery teams to enhance translation and portfolio success. Leads a team of Oncology Early Clinical Development Medical Directors and Clinical Scientists to design and execute early-phase studies and contribute to translational research strategy for early assets. Requires on-site presence 2–3 days per week in specified locations.

Responsibilities

• Accountable for the clinical development plans (CDPs) for a portfolio of early phase (Phase I/II) trials, including first-in-human, dose-escalation, and proof-of-concept studies.
• Manage overall benefit:risk of a clinical program and interface with appropriate physicians if not a physician oneself.
• Drive end-to-end clinical development strategy aligned to TMP and IEP across all phases, including trial design, execution, and interpretation of results.
• Lead clinical development discussions at regulatory interactions and draft components of regulatory submissions/files (IND, NDA, BLA, MAA).
• Participate as a core member of MDT/EDT, providing Clinical Development accountability at the program level within cross-functional partnerships.
• Ensure studies are conducted in compliance with regulatory requirements, GCP, and GSK policies.
• Lead the cross-functional Clinical Matrix Team, providing clinical leadership and oncology expertise.

Translational Research Strategy

• Oversee clinical development components of the translational science strategy in partnership with Oncology Early Development Leaders and related teams.
• Partner with Oncology Tumor Teams to develop translational strategy across assets within a tumor and drive OTT activities with clinical/translational focus.
• Advance 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 and regulatory documents, and oversee safety analyses and responses to health authority queries.
• Author/review abstracts, presentations, and manuscripts for accuracy and content.
• Prepare for governance discussions with cross-functional teams and other business lines.
• Lead preparation of clinical sections for regulatory filings and support investigator/consultant meetings.
• Present study results and translational insights to internal/external stakeholders, including senior management and regulatory agencies.

Collaboration and Communication

• Integrate inputs across disciplines to ensure alignment and successful translational research initiatives.
• Build and maintain relationships with external experts, KEEs, and academic collaborators.
• Collaborate with Principal Investigators/Steering Committees on publications related to clinical data.
• Serve as program medical expert for internal/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, with regular staff meetings and 1:1s.
• Guide direct reports to ensure cross-functional alignment and efficient CDP/translational strategy execution.
• Foster a One Oncology culture: bold, swift, and integrity-driven, with strong standards for clinical documents and data review.

Qualifications

• Required: PhD or PharmD (Advanced degree); clinical and research experience in Oncology; experience designing/executing early-phase trials (including FIH/POC) and translational research; familiarity with treatment guidelines and regulatory drug approval processes; experience developing translational strategy (biomarkers, companion diagnostics, PK/PD modeling).
• Preferred: MD; board certification/eligibility in oncology; GI oncology experience; deep knowledge of GCP/ICH/FDA/EMEA/NICE guidelines; strong data analysis/interpretation skills; proven matrix-team leadership; strong business acumen; excellent communication and scientific writing abilities; ability to influence and negotiate; willingness to relocate or work across multiple US locations (salary ranges provided in region-specific postings).