Director - Diagnostic Execution (Oncology Translational Medicine)
GSK
Summary
This role is in the Diagnostic Execution Team, part of GSK's Oncology Translational Medicine (OTM) function for Research & Development. The team is responsible for operational delivery of clinical biomarker and diagnostic strategies to support GSK's oncology portfolio, working cross-functionally to enable successful implementation of biomarker and diagnostic strategies across clinical development.
Job description
Job Purpose
As Director (Diagnostic Execution) you provide operational leadership for diagnostic activities across GSK's Antibody Drug Conjugate (ADC) portfolio. Managing a team of Diagnostic Delivery Leads you will be accountable for execution of biomarker and diagnostic strategies (including oversight of external testing partners and delivery of diagnostic milestones) to support clinical development, regulatory submissions, and diagnostic approvals. The role reports into the Senior Director, Head of Diagnostic Execution and ensures diagnostic activities are delivered to quality, timeline, budget, and regulatory requirements, whilst enabling successful drug-diagnostic co-development.
Key Responsibilities
- Managing operational delivery of biomarker and diagnostic activities for patient selection or stratification across the ADC portfolio, ensuring alignment between therapeutic development plans and diagnostic deliverables and oversee diagnostic timelines, budgets, assay performance metrics, risks and mitigation plans.
- Provide operational leadership to diagnostic programs (from assay development through regulatory approval), partnering with Diagnostic leads, Clinical Development, Regulatory Affairs, and diagnostic manufacturers to support drug-diagnostic co-development.
- Lead relationships with external parties (including laboratories, CROs, central laboratories, and diagnostic manufacturers), overseeing vendor selection (contracting, governance, performance management, and quality compliance) and successful global deployment of diagnostic assays.
- Drive operational excellence, continuous improvement, inspection readiness, and compliance with GCP, GDPR, and global regulatory requirements.
Basic Qualifications
- Relevant degree-level education (eg; life-sciences) and previous line-management experience.
- Relevant experience / knowledge of oncology diagnostic development, implementation, and operational delivery.
- Experience managing vendor relationships (eg; external laboratories and diagnostic vendors).
- Strong knowledge of biomarker-driven drug development, precision medicine, and global clinical development processes.
- Proficiency with a range of digital tools (including Excel, PowerPoint, Word, SharePoint, Teams) and experience leveraging AI or digital technologies to improve efficiency or insights.
Preferred Qualifications
- Advanced relevant scientific degree (eg; M.S. or PhD).
- Experience supporting Antibody Drug Conjugate (ADC) development programs.
- Experience in companion diagnostic development and drug-diagnostic co-development.
- Knowledge of global In Vitro Diagnostic Medical Device Regulation (IVDR) / CDx regulatory requirements and interactions with health authorities.
- Experience supporting regulatory submissions, inspections, and audits.
Requirements
- Relevant degree-level education (eg; life-sciences)
- Previous line-management experience
- Relevant experience / knowledge of oncology diagnostic development, implementation, and operational delivery
- Experience managing vendor relationships (eg; external laboratories and diagnostic vendors)
- Strong knowledge of biomarker-driven drug development, precision medicine, and global clinical development processes
- Proficiency with digital tools (Excel, PowerPoint, Word, SharePoint, Teams)
- Experience leveraging AI or digital technologies to improve efficiency or insights
- Advanced relevant scientific degree (eg; M.S. or PhD) preferred
- Experience supporting Antibody Drug Conjugate (ADC) development programs preferred
- Experience in companion diagnostic development and drug-diagnostic co-development preferred
- Knowledge of global IVDR / CDx regulatory requirements and interactions with health authorities preferred
- Experience supporting regulatory submissions, inspections, and audits preferred
Company overview
GSK plc (formerly GlaxoSmithKline) is a British multinational pharmaceutical and biotechnology company headquartered in London, England. Founded in 2000 through the merger of Glaxo Wellcome and SmithKline Beecham, GSK has grown to become one of the world's leading healthcare companies with operations in over 150 countries. The company specializes in researching, developing, and manufacturing prescription medicines, vaccines, and consumer healthcare products. GSK's therapeutic areas include respiratory diseases, HIV/AIDS, oncology, immunology, and infectious diseases. The company is particularly renowned for its vaccine portfolio and has been at the forefront of developing treatments for major global health challenges. With approximately 70,000 employees worldwide, GSK maintains a strong commitment to scientific innovation and has a significant presence in key markets including the United States, Europe, and emerging economies. The company's mission is to unite science, technology, and talent to get ahead of disease together, aiming to positively impact the health of 2.5 billion people by the end of the decade.