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.
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Our approach to R&D
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, Oncology Early Translational Biomarkers
Are you an experienced leader in Oncology Translational Medicine (OTM) looking to be part of an innovative, dynamic and growing organization? Do you thrive at the intersection of biomarker strategy, early clinical development and mechanistic research across multiple therapeutic modalities? If so, this Director, Oncology Early Translational Biomarkers is an exciting opportunity to explore.
GSK Oncology has a rapidly growing and diverse pipeline spanning novel small molecules, first- and best-in-class large molecules, and cutting-edge therapies, the opportunity to shape translational strategy across our early Oncology programs represents a rare and exciting career opportunity. You will partner with world-class scientists, clinicians, and KOLs—making decisions that directly impact patients with cancer.
Job Purpose:
The Director , Oncology Early Translational Biomarkers is accountable for the definition and implementation of a translational biomarker strategy and delivery across a expanding early oncology portfolio of spanning both small and large molecules, novel modalities and immune cell engagers.
The Early Translational Biomarkers team provides end-to-end translational medicine support from development and integration of biomarker strategies, assay development and technical validation through clinical deployment and data interpretation across early-phase proof of concept studies.
You will be the scientific and operational owner of translational medicine strategy for the early Oncology portfolio, embedded as the dedicated translational lead across program teams. You will deliver biomarker and translational strategies from preclinical through Phase 1. The role covers a wide range of therapeutic modalities requiring deep disease biology expertise, versatile biomarker and assay knowledge alongside experience in clinical implementation. The role partners closely with Oncology Research Unit, Discovery, Innovative Biological Model Systems, Clinical Development and Oncology Tumour teams, Clinical Operations, Diagnostics, Biomarker Operations and external partners to ensure translational readiness, de-risk clinical entry and accelerate go/no-go decisions.
Key Responsibilities:
- Act as the translational medicine lead for assigned early Oncology programs (preclinical to Phase 1): define and own biomarker and translational strategies, plans and decision-enabling datasets.
- Identify cutting edge science and technological advances and incorporate them into biomarker strategies to guide indication selection, patient enrichment, and combination strategies.
- Develop program-specific translational plans including hypothesis-driven biomarker selection, assay strategy (fit-for-purpose), sample collection/handling, and statistical/analysis plans.
- Provide scientific input into target validation and discovery phases, pharmacology, PK/PD, target engagement, mechanism-of-action and patient selection strategies across modalities.
- Lead assay selection, qualification/validation strategy and oversight (internal and external CROs/diagnostic partners); ensure data quality and regulatory/compliance readiness.
- Integrate preclinical model data with clinical development plans, informing dose selection, biomarker endpoints and translational go/no-go criteria.
- Serve as the primary cross-functional interface for translational questions—represent translational perspectives in program governance, clinical project teams, and portfolio reviews.
- Translate complex scientific evidence into clear risk/benefit and go-to-clinic recommendations for portfolio decision-making.
- Prepare and present translational updates, sections for clinical protocols, investigator brochures, regulatory briefing documents and scientific reports.
- Mentor and support the development of junior scientists; contribute to team capability building and knowledge sharing.
- Manage external scientific partnerships (academic collaborators, CROs, diagnostics vendors) to deliver assays, sample logistics and high-quality data.
- Contribute to resource planning, budgets and timelines for translational activities for assigned programs.
Translational Strategy, Delivery and implementation
- Develop and own comprehensive translational science strategies for early Oncology programs across a range of therapeutic modalities based on the best available science and technologies. Supporting patient selection, target engagement, pharmacodynamics (PD), mechanism of action (MoA), and mechanism of resistance (MoR) from preclinical through Phase 1/proof of concept clinical studies.
- Define and execute biomarker plans that deliver robust, decision-quality data to support Go/No-Go (GNG) milestones, dose and schedule selection, regulatory submission sand interactions.
- Apply deep Oncology expertise to generate disease-linkage data guiding indication selection and expansion.
- Define and study mechanisms of resistance at relapse to support reverse translation efforts and inform next-line strategies, patient enrichment and influence early discovery efforts.
- Lead the identification, development, and analytical validation of fit-for-purpose translational assays, deploying internally and/or via external partners (CROs, academic labs).
- Oversee clinical biomarker implementation: sample collection strategies, laboratory manuals, biomarker sections of clinical study protocols, informed consent forms and statistical/analysis plans for early first time in human studies.
- Integrate clinical biomarker analyses to enable patient selection, enrichment, and response monitoring.
- Partner with cross functional groups within OTM on sample management, biomarker testing, data generation, documentation, traceability, CDx pathway considerations, and regulatory expectations for analytical validation.
- Ensure all biomarker data and deliverables meet quality standards for inclusion in clinical study reports, regulatory filings, and scientific publications.
Cross-Functional Leadership & Portfolio Influence
- Serve as the TML representative on early project development teams, collaborating with key groups across Oncology Research Unit, Oncology Research and Discovery, Clinical Development, Clinical Operations, and Product Development to integrate translational strategies throughout the early stage of drug discovery and development.
- Influence translational strategy across the broader GSK Oncology portfolio, sharing scientific insights and establishing best practices for early programs.
- Represent GSK at scientific forums, congresses, and key opinion leader (KOL) engagements as an external ambassador for the program.
- Contribute to and ensure the quality of TM clinical study reports, data reviews, interpretations, presentations, and recommendations to development teams and senior management.
Why You?
Basic Qualifications:
- PhD and/or MD with substantive experience in Oncology, immune-Oncology drug development.
- Minimum 5 years of experience in translational medicine, biomarker science, clinical development and particularly the application of biomarkers in Oncology clinical trials within the pharmaceutical or biotechnology industry.
- Expertise in cancer biology across key disease areas of focus (Lung: NSCLC/SCLC, GI: CRC, Haem: MM, Gynaecological cancers) and the therapeutic landscape including approved and investigational agents.
- Demonstrated expertise across multiple therapeutic modalities relevant to the GSK portfolio: large molecules, small molecules and immune cell engagers.
- Proven track record of designing and executing translational biomarker strategies in early- and late-phase clinical trials, including assay development, validation, and clinical deployment.
- Hands-on experience of implementation of a range of biomarker platforms including flow cytometry, molecular diagnostics (NGS, FISH, PCR), and/or IHC/IF for Oncology clinical trials.
- Experience in driving, managing, executing, and delivering results for complex, multi-functional projects in a matrixed pharmaceutical environment.
Preferred Qualifications:
- Strong interpersonal skills and ability to thrive in a matrix environment
- Experience with CTD/ctDNA platforms and liquid biopsy approaches for monitoring drug response.
- Digital pathology and AI/ML integration experience for biomarker analyses.
- Experience integrating multi-omic biomarkers (flow, NGS, proteomics, cytokines) into clinical decision-making frameworks.
- Demonstrated scientific capability as evidenced by publications, research reports, and external presentations in translational Oncology, or clinical biomarkers.
- Highly developed problem-solving, critical thinking, and risk management skills with exceptional attention to scientific detail.
- Proven communication, presentation, and influencing skills; ability to translate complex biomarker data into clear, decision-enabling insights for cross-functional audiences.
- Strong collaborative working skills with experience navigating complex multi-stakeholder environments.
- Ability to act as an external ambassador and to influence external organizations to enhance the scientific reputation of GSK.
- Proven ability to mentor and develop scientific colleagues.
Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. At we are dedicated to being a Great Place to Work, where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. We champion an inclusive culture that celebrates diversity and collaboration, and we are always committed to lifelong learning, growth, and development.
#LI-GSK*
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
• 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. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and 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.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
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.
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