Associate Director- Diagnostics Precision Medicine

Position Summary

Associate Director – Diagnostics Oncology Translational Medicine - as a member of the Precision Diagnostics team, you will contribute to the implementation of GSK diagnostic strategies supporting drug development, including technical, clinical, regulatory, commercial, intellectual property and business development components. You will lead diagnostic projects and work streams according to agreed deliverables, timelines and budget, within a matrix cross‑functional environment.

• Support development of end‑to‑end diagnostic strategy across early and late‑stage clinical studies aligned with biomarker and clinical development plans.
• Accountable for tactical execution with external partners to develop, validate, and implement diagnostic tests for clinical studies.
• Oversee technical development, validation and implementation of diagnostic assays within a clinical trial.
• Collaborate with clinical operations and sample management to ensure diagnostic testing and data generation is compliant with all regulatory requirements.
• Manage and deliver projects/work streams within agreed timelines and budgets.
• Work within, and may lead, matrix teams to ensure efficient implementation of all key deliverables for diagnostic projects.
• Support regulatory interactions by contributing to the writing and review of diagnostic portions of briefing documents, informed consents, clinical protocols, schedule of activities, and clinical study reports.
• Contribute to the implementation of strategies to manage risks on clinical study timelines, budgets and goals, balancing risk/benefit with clear understanding of impact on project.
• Build and maintain networks with regulatory, clinical and biomarker leads, clinical study teams, project management, business operations, and IVD partner joint project team members to coordinate activities and ensure timely dissemination of information.

• PhD with 3+ years OR MS with 5+ years of experience in pharmaceutical or IVD development.
• Experience in clinical trial design and execution (efficacy endpoints, biomarker testing), sample operations, data management, and human biological specimen management.
• Experience in translational biomarker investigation including biomarker operations and data management.
• Experience with IVD development including design history file evaluation, risk assessments, and all related analytical and clinical validation requirements.
• Experience with technical platforms that include IHC, immunoassay, PCR, NGS, and novel assay technologies (digital pathology, liquid biopsy).

• Experience in drug‑diagnostic co‑development in oncology.
• Experience evaluating and auditing partners for clinical biomarker test execution.
• Familiarity with clinical laboratory and medical device requirements in the US and EU (GCP/GCLP, CAP/CLIA, ISO
  15189, ISO
  13485, etc.).
• Knowledge of US and Ex‑US diagnostic testing and regulatory landscape, including evolving IVDR requirements in the EU, QSR regulations, and GMP manufacturing.
• Experience authoring and reviewing regulatory documents including pre‑submission packets, SRD, IDE, HDE and ODD applications, 510(k) and PMA submissions for ClassII and ClassIII devices.
• Able to manage multiple projects including assessment of bandwidth and resourcing requirements to deliver the team’s objectives.
• Track record of success working within a matrix team environment.
• Detail‑oriented with strong organization skills.
• Exceptional written and verbal communication skills.
• Proficiency with MS Office and collaboration tools such as Teams.

This position is hybrid, combining remote work with time in the office for team collaboration and critical meetings. Specific on‑site expectations will be discussed during the interview process.

Salary ranges for the US market (based on location) are $150,975 to $251,625 for new hires, plus an annual bonus and eligibility for a share‑based long‑term incentive program. Benefits include healthcare and other insurance, retirement benefits, paid holidays, vacation, paid caregiver/parental and medical leave.

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.