Director, Precision Diagnostics Oncology

GSK • Upper Providence, PA

13h • $189,750 - $316,250 • Hybrid

About The Position

The Director, Precision Diagnostics Oncology implements diagnostic development across technical, development, regulatory, commercial, and business-development activities, delivering against agreed objectives, timelines, and budgets. The role leads diagnostic projects and workstreams and partners with research, clinical development, regulatory, and commercial teams to build and execute diagnostic strategies aligned with oncology development needs. The position contributes to GSK’s goal of advancing innovation in diagnostics to help treat the right patient with the right medicine.

The role executes precision diagnostics strategies across oncology programs, multiple assets, and therapeutic areas; defines diagnostic requirements for trials; and works with clinical teams on biomarker selection, assay validation, and biological sample collection and handling. It oversees plans, budgets, and timelines and collaborates across functions and with external diagnostic companies, clinical laboratories, and technology vendors. It also supports regulatory and quality requirements and submissions, provides project updates, and shares practices that improve diagnostic development and organizational processes.

This is a hybrid role requiring regular on-site work and collaboration with colleagues across sites. For candidates based at Stevenage, the role will initially be based there, with a planned move to Cambridge, UK, proposed by early 2029. The posting also states that, for candidates based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary range is $189,750–$316,250. The position offers an annual bonus and eligibility for a share-based long-term incentive program, subject to role level.

Requirements

• Bachelor’s degree in life sciences, molecular diagnostics, clinical laboratory science, or a related field.
• At least 6 years of experience in diagnostic development.
• Demonstrated experience integrating diagnostics into clinical trial design and familiarity with trial design elements such as efficacy endpoints, biomarker testing, data management, and human biological specimen management and operations.
• Knowledge of diagnostic or companion diagnostic regulatory requirements, such as FDA, EU IVDR, and PMDA/MHLW Japan requirements.
• Experience developing protocols, informed consents, and analysis plans 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 experience working with clinical teams, external partners, and clinical laboratories.
• Demonstrated ability to communicate clearly and effectively across teams and collaborate openly.

Nice To Haves

• Direct experience in oncology.
• Advanced degree (MS, PhD, or 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 such as ISO 13485, and/or GMP manufacturing.
• Experience partnering with commercial teams to enable diagnostic launch and market adoption.

Responsibilities

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

Benefits

• Annual bonus.
• Eligibility to participate in a share-based long-term incentive program, dependent on role level.
• Health care and other insurance benefits for employees and family.
• Retirement benefits.
• Paid holidays.
• Vacation.
• Paid caregiver, parental, and medical leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Director