Business Introduction
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.

Position Summary
Are you a professional in the diagnostics field looking to advance your career? If so, this Associate Director - Diagnostics Oncology Translational Medicine role may be an ideal opportunity to explore. 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 workstreams according to agreed deliverables, timelines and budget, within a matrix cross-functional environment.

Key Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• 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/workstreams 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. Contributes to decisions which balance 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.

Basic Qualification

• 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 in technical platforms that include IHC, immunoassay, PCR, NGS, and novel assay technologies (digital pathology, liquid biopsy).

Preferred Qualification

• Experience in drug-diagnostic co-development in oncology.
• Experience in evaluating and auditing partners for clinical biomarker test execution.
• Familiarity with clinical laboratory and medical device requirements in the US and EU including: GCP/GCLP, CAP/CLIA, ISO15189, ISO13485, 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 Class II and Class III 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.

Working arrangement
This position is hybrid. You will combine remote work with time in the office for team collaboration and critical meetings. Specific on-site expectations will be discussed during the interview process.

GSK is an Equal Opportunity Employer.