Director, Precision Oncology Diagnostics

1925 GlaxoSmithKline LLC; Upper Providence (Delaware County); Hybrid; USD 190,000 - 316,000; Full time

Benefits offered by this job

Health care and other insurance

Retirement benefits

Paid holidays

Vacation

Parental and medical leave

Job summary

GlaxoSmithKline (GSK) invites applications for a Director of Precision Diagnostics Oncology. You will lead diagnostic development programs across oncology, drive biomarker strategies, and partner with clinical, regulatory, and commercial teams to deliver impactable diagnostics projects.

The role requires leadership across functions, advanced biologic/pharma diagnostics expertise, and ability to navigate regulatory submissions while managing budgets and timelines.

Qualifications

• 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.

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.

Skills

Analytical thinking

Clinical data interpretation

Clinical data review

Clinical development

Trial designs

Trial monitoring

Digital fluency

Regulatory affairs

Executive presence

Hematology & Oncology

Real world evidence

Scientific presentations

Education

Bachelor’s degree in life sciences, molecular diagnostics, clinical laboratory science, or related field

Advanced degree (MS, PhD, MD) in a relevant discipline

Job description

GlaxoSmithKline (GSK) invites applications for a Director of Precision Diagnostics Oncology. You will lead diagnostic development programs across oncology, drive biomarker strategies, and partner with clinical, regulatory, and commercial teams to deliver impactable diagnostics projects.

The role requires leadership across functions, advanced biologic/pharma diagnostics expertise, and ability to navigate regulatory submissions while managing budgets and timelines.