Director, Precision Diagnostics Oncology

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

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.

Find out more: Our approach to R&D

Location

For candidates seeking to be located at our Stevenage site, this role will temporarily be based at Stevenage. However, the Company plans to relocate its offices to Cambridge, UK. The location of this role will therefore subsequently change to Cambridge, UK in accordance with timelines to be set by the Company. The relocation is currently proposed to take effect by early 2029.

Director, Precision Diagnostics Oncology

Position Summary
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. You will lead diagnostic projects and workstreams and partner cross‑functionally with research, clinical development, regulatory, and commercial groups. You will help build and execute diagnostic strategies and solutions that align with oncology development needs. You will have the responsibility to deliver on the vision of equipping GSK to be a leader through innovation and diagnostic 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 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 Qualifications

• 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.

Key Skills

LI-GSK* Hybrid* Skills Analytical Thinking, Clinical Data Interpretation, Clinical Data Review, Clinical Development, Clinical Trial Designs, Clinical Trials Monitoring, Digital Fluency, Drug Regulatory Affairs, Executive Presence, Hematology and Oncology, Learning Agility, Matrix Leadership, Real World Evidence (RWE), Scientific Presentations

Salary and Benefits

If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $189,750 to $316,250. The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role.

• health care and other insurance benefits (for employee and family)
• retirement benefits
• paid holidays
• vacation
• paid caregiver/parental and medical leave

If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process. Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Accessibility

If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - [e-mail].

Equal Opportunity

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

About GSK

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

Find out more on our career site.