Director / Senior Director, Oncology Early Translational Biomarkers

GSK•Waltham, MA

4d•Hybrid

About The Position

This role is for an experienced leader in Oncology Translational Medicine (OTM) looking to join an innovative, dynamic, and growing organization. The position focuses on biomarker strategy, early clinical development, and mechanistic research across multiple therapeutic modalities. GSK Oncology has a diverse pipeline including novel small molecules, large molecules, and cutting-edge therapies. The opportunity involves shaping translational strategy for early Oncology programs and partnering with scientists, clinicians, and KOLs to impact patients with cancer.

Requirements

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.

Nice To Haves

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.

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.
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.
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.