
Director - Diagnostic Execution (Oncology Translational Medicine)
Upper Providence, PAJobSeen 4 days agoSeen in employer's feed 4 days ago
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Job overview
The Director of Diagnostic Execution provides operational leadership for diagnostic activities across GSK’s oncology ADC portfolio. The role manages Diagnostic Delivery Leads and oversees execution of biomarker and diagnostic strategies, external testing partners, and diagnostic milestones supporting clinical development, regulatory submissions, and approvals. It works across functions and vendors to deliver activities to quality, timeline, budget, and regulatory requirements and enable drug-diagnostic co-development.
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Full job description
This role is in the Diagnostic Execution Team, which is part of GSK's Oncology Translational Medicine (OTM) function for Research & Development (R&D). 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. Key stakes-holder & customer groups include Clinical Development, Clinical Biomarkers, Diagnostic Strategy, Regulatory, Clinical Operations, Quality, Procurement, Data Management, Human Biological Sample Management (HBSM), external CROs and diagnostic partners. **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 (include..): 1. 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. 2. Provide operational leadership to diagnostic programs (from assay development through regulatory approval). This includes partnering with Diagnostic leads, Clinical Development, Regulatory Affairs, and diagnostic manufacturers (to support drug-diagnostic co-development). 3. Lead relationships with external parties (including laboratories, CROs, central laboratories, and diagnostic manufacturers). This extends to overseeing vendor selection (eg; contracting, governance, performance management, and quality compliance) and the successful global deployment of diagnostic assays and achievement of operational performance. * Drive operational excellence, continuous improvement, inspection readiness, and compliance with GCP, GDPR, and global regulatory requirements. Location: Stevenage (UK) or Upper Providence (USA). Please Note: If the successful applicant is based at Stevenage site: This role will temporarily be based at Stevenage. However, the Company plans to relocate its offices to Cambridge, UK. The location of this role will therefore subsequently change to Cambridge UK, in accordance with timelines to be set by the Company. The relocation is currently proposed to take effect by early 2029. About GSK: At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together. Find out more - our approach to R&D: https://www.gsk.com/en-gb/innovation/ APPLICATION CLOSING DATE - Monday 2nd of November 2026 (COB). Basic Qualifications: 1. Relevant degree-level education (eg; life-sciences) and previous line-management experience. 2. Relevant experience / knowledge of oncology diagnostic development implementation, and operational delivery. 3. Experience managing vendor relationships (eg; external laboratories and diagnostic vendors). 4. Strong knowledge of biomarker-driven drug development, precision medicine, and global clinical development processes. 5. 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: 1. Advanced relevant scientific degree (eg; M.S. or PhD). 2. Experience supporting Antibody Drug Conjugate (ADC) development programs. 3. Experience in companion diagnostic development and drug-diagnostic co-development. 4. Knowledge of global In Vitro Diagnostic Medical Device Regulation (IVDR) / CDx (Companion Diagnostic Device) regulatory requirements and interactions with health authorities. 5. Experience supporting regulatory submissions, inspections, and audits. Skills Analytical Thinking, Clinical Data Interpretation, Clinical Data Review, Clinical Development, Clinical Trial Designs, Clinical Trials Monitoring, Cross-Departmental Collaboration, Digital Fluency, Drug Regulatory Affairs, Executive Presence, Hematology and Oncology, Learning Agility, Matrix Leadership, Scientific Presentations Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at [email protected] where you can also request a call. Please note should your en
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