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.

In this Diagnostic Director role, you will implement diagnostic development encompassing technical, development, regulatory, commercial, and business development efforts according to agreed deliverables, timelines and budget.

Responsibilities:

• Execution of precision diagnostics strategy for oncology programs, spanning multiple assets and therapeutic areas.
• Define diagnostic requirements for trials and, in partnership with clinical teams, implement biomarker selection, assay validation, and biological sample collection/handling strategy.
• Oversee project plans, budgets, and timelines to ensure on-time, high-quality delivery of diagnostic milestones via cross-functional collaboration with project management, biomarkers, clinical & biomarker operations, external engagement, procurement, etc.
• Work with regulatory and quality teams to ensure diagnostic development meets regulatory expectations and requirements and in diagnostic regulatory submissions.
• Engage external partners, including diagnostic companies, clinical labs and technology vendors, to accelerate assay development and access to patient samples.
• Provide frequent project status updates and reports related to diagnostic deliverables to the Diagnostic Subteam, in collaboration with project management, finance and business operations.
• Share learnings and best practices for diagnostic development and execution and participate in initiatives for key organizational process improvements.

Basic Qualification:

• Bachelor’s degree in life sciences, molecular diagnostics, clinical laboratory science, or related field.
• 6+ years of experience in diagnostic development, direct experience in oncology is preferred.
• Demonstrated 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.
• Knowledge of regulatory requirements for diagnostics or companion diagnostics (i.e. FDA, EU IVDR, PMDA/MHLW Japan, etc).
• Protocol, informed consent and analysis plan development required to support diagnostic development and regulatory submissions.
• Proven ability to manage cross-functional projects, timelines, and budgets in a matrix environment.
• Strong stakeholder management skills, including working with clinical teams, external partners and clinical laboratories.
• Demonstrated ability in clear, effective, cross-team, open communications and collaboration.

Preferred Qualification:

• Advanced degree (MS, PhD, MD) in a relevant discipline.
• Experience developing 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, clinical laboratory operations, quality management systems (i.e. ISO 13485) and/or GMP manufacturing.
• Experience partnering with commercial teams to enable diagnostic launch and market adoption.

Working Model: This is a hybrid role. 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.

Salary: $189,750 to $316,250 per year