Director - Precision Diagnostics - Oncology
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
In thisDiagnosticDirectorrole, youwill implementdiagnosticdevelopment encompassing technical, development, regulatory, commercial, and business development effortsaccording to agreed deliverables, timelines and budget. You willleaddiagnosticprojects and workstreams andpartner cross-functionally withresearch, clinical development, regulatory, and commercial groups. You willhelpbuild and execute diagnostic strategiesand solutionsthat align withoncologydevelopmentneeds.
You will have the responsibility to deliver on the vision of equipping GSK to be a leader through innovation and Dx development driving value by treating the right patient with the right medicine.
Responsibilities:
- Execution of precision diagnostics strategy for oncology programs, spanning multiple assets and therapeutic areas.
- Define diagnostic requirements for trialsand, in partnership with clinical teams,implementbiomarker selection, assay validation, andbiologicalsamplecollection/handlingstrategy.
- Oversee project plans, budgets, and timelines to ensure on-time, high-quality delivery of diagnostic milestonesviacross-functionalcollaborationwithproject management, biomarkers,clinical& biomarkeroperations, external engagement, procurement, etc.
- Work with regulatory and quality teams to ensure diagnostic development meets regulatory expectationsand requirementsand in diagnostic regulatory submissions.
- Engage external partners, includingdiagnostic companies,clinical labsandtechnology vendors, to accelerate assay development and access to patient samples.
- Provide frequent project status updatesandreports related todiagnosticdeliverablesin collaboration withproject management, finance and business operations/
- Sharelearnings and best practicesfor diagnostic development and executionand participate ininitiativesforkey organizational processimprovements.
Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
- Bachelor’s degree in life sciences, molecular diagnostics, clinical laboratory science, or related field.
- 6+ years of experience in diagnostic development, biomarker strategy, and/or clinical assay development, with at 2+ years direct experience in oncology diagnostic development.
- Experience integrating diagnostics into clinical trial design and familiarity with clinical trial design elements such as efficacy endpoints, biomarker testing, data management and human biological specimen management and operations.
- Experience in regulatory requirements for diagnostics or companion diagnostics and quality management systems, including FDA and EU medical device regulations and QSR regulations, GMP manufacturing, ISO13485, etc.
- Diagnostic protocol and analysis plan development required to support diagnostic development and regulatory submissions
- Management of cross-functional projects, timelines, and budgets in a matrix environment.
- Stakeholder management, including working with clinical teams, external partners and clinical laboratories.
Preferred Qualification s
If you have the following characteristics, it would be a plus:
- Advanced degree (MS, PhD, MD) in a relevant discipline.
- Experience developing next-generation sequencing (NGS), PCR, immunohistochemistry, or other oncology biomarker assays as diagnostics and/or for clinical use.
- Experience contributing to regulatory submissions or interactions for diagnostic devices or assays.
- Familiarity with laboratory accreditation standards and clinical laboratory operations.
- Experience partnering with commercial teams to enable diagnostic launch and market adoption.
- Demonstrated ability in clear, effective, cross-team, open communications and collaboration.
Working Model
This is a hybrid role based in the United States. You will be expected to work on-site regularly and collaborate closely with colleagues across sites.
What We Value
We seek people who bring curiosity, humility, and a patient-first mindset. We welcome different perspectives and encourage inclusion. We support professional growth and offer opportunities to lead complex, high-impact work that advances care for people with cancer.
How to Apply
If you want to help shape diagnostics that improve patient outcomes, we encourage you to apply. Please submit your CV and a brief cover letter describing your relevant experience and why this role matters to you. We look forward to hearing from you.
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