Executive Director, Clinical Development Lead - Oncology

Role Summary

Executive Director, Clinical Development Lead (CDL) – Oncology, accountable for the Clinical Development Plan (CDP) and providing clinical and strategic leadership to the program. On-site presence 2 to 3 days a week in specified locations.

Responsibilities

• Act as the single point of accountability for clinical development plans (CDPs) of an asset, including oversight of disease strategies, indications, and associated clinical trial program data.
• Participate as a core member of the Medicine Development team or Early Development Team and provide clinical development accountability at the program level within cross-functional partnerships.
• Be accountable for the overall benefit and risk of a clinical program; if not a physician, delegate to and interface with an appropriate physician.
• Lead cross-functional Clinical Matrix Team, providing clinical leadership and oncology expertise for the program.
• Guide direct reports to ensure cross-functional integration, coordination, collaboration, and alignment for CDP execution.
• Contribute strategic guidance to portfolio development strategies, study design and conduct, combination strategies, and disease area strategies.
• Interpret complex clinical data, identify trends for clinical and regulatory documents, and engage in safety analyses and responses to health authority queries.
• Prepare for governance discussions in collaboration with the Medicine Development Leader (MDL) and other business lines.
• Manage a team of physicians and/or scientists and allocate resources across the program.

Additional Responsibilities

• Author and/or review abstracts, presentations, and manuscripts for accuracy of clinical data and content.
• Contribute to establishing standards for clinical documents and data review processes across Oncology Clinical Development.
• Interpret data analyses of clinical trial results and support development of clinical study reports.
• Lead preparation of clinical sections of regulatory filings (IND, study reports, NDA, annual reports, etc.).
• Serve as program clinical expert for internal and external collaborators, investigators, consultants, and contract resources.
• Lead and provide clinical support for investigator and consultant meetings (e.g., investigator meetings, clinical advisory boards).
• Lead recruitment, hiring, and training for direct report team roles.
• Provide ongoing coaching, development and leadership for direct reports; conduct regular staff meetings, check-ins, and 1:1 meetings.

Qualifications

• Required: Advanced degree (PhD or PharmD).
• Required: Minimum of 8 years pharmaceutical or relevant scientific/medical/clinical experience, with at least 5 years in Oncology (clinical development experience in one of the four strategic focus areas preferred).
• Required: Cross-functional medicine development knowledge and business acumen.
• Required: Experience writing scientific communications with clarity, accuracy, and rigor in compliance with disclosure and publication principles.
• Required: Robust knowledge of Oncology treatment guidelines, therapeutic landscape, and the clinical development and drug approval processes in major regions.

Preferred Qualifications

• Medical Degree and Oncology board certification/eligibility/registration.
• Knowledge of GCP, ICH, FDA, EMEA, NICE guidelines and regulations.
• Strong understanding of medical and drug terminology; foundation in pharmacology.
• Excellent communication skills; ability to present complex data and strategies to all organizational levels.
• Understanding of product and safety profiles; data analysis and clinical relevance experience.
• Experience leading matrix teams with a track record of high performance.
• Proven decision-making and problem-resolution abilities in critical situations; adaptability to changing environments.
• Ability to engage with Oncology Clinical Development Culture and broad GSK environment with professionalism.
• Understanding of adverse effect detection, investigation, assessment and prevention.
• Strong negotiating and influencing skills to guide clinical decisions.