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GSK

Develops medicines, vaccines, and consumer health

Director, Oncology Early Translational Biomarkers

Biology & BiotechConfirmed live in the last 24 hours
Full-timeWaltham, MA, USAHybrid

About the Job

Requirements

  • A PhD and/or MD with substantive experience in oncology and immuno-oncology drug development is required.
  • At least 5 years of experience in translational medicine, biomarker science, or clinical development, particularly applying biomarkers in oncology clinical trials within the pharmaceutical or biotechnology industry, is required.
  • Expertise in cancer biology across key focus areas including lung cancers (NSCLC/SCLC), gastrointestinal cancers (CRC), hematologic cancers (MM), and gynecological cancers, and knowledge of the therapeutic landscape including approved and investigational agents, is required.
  • Demonstrated expertise across multiple therapeutic modalities relevant to the portfolio, including large molecules, small molecules, and immune cell engagers, is required.
  • A proven track record designing and executing translational biomarker strategies in early- and late-phase clinical trials, including assay development, validation, and clinical deployment, is required.
  • Hands-on experience implementing biomarker platforms including flow cytometry, molecular diagnostics (NGS, FISH, PCR), and/or IHC/IF for oncology clinical trials is required.
  • Experience driving, managing, executing, and delivering results for complex, multi-functional projects in a matrixed pharmaceutical environment is required.

Responsibilities

  • Act as translational medicine lead for assigned early oncology programs from preclinical through Phase 1, defining and owning biomarker and translational strategies, plans, and decision-enabling datasets.
  • Identify scientific 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, fit-for-purpose assay strategy, sample collection and handling, and statistical and analysis plans.
  • Provide scientific input into target validation and discovery, pharmacology, pharmacokinetics/pharmacodynamics, target engagement, mechanism of action, and patient selection strategies across modalities.
  • Lead assay selection and qualification/validation strategy and oversight with internal and external contract research organizations and diagnostic partners, ensuring data quality and regulatory/compliance readiness.
  • Integrate preclinical model data with clinical development plans to inform dose selection, biomarker endpoints, and translational go/no-go criteria.
  • Serve as the primary cross-functional interface for translational questions and represent translational perspectives in program governance, clinical project teams, and portfolio reviews.
  • Translate complex scientific evidence into risk/benefit and go-to-clinic recommendations for portfolio decision-making.
  • Prepare and present translational updates, clinical protocol sections, investigator brochures, regulatory briefing documents, and scientific reports.
  • Mentor and support junior scientists and contribute to team capability building and knowledge sharing.
  • Manage external scientific partnerships, including academic collaborators, contract research organizations, and diagnostics vendors, to deliver assays, sample logistics, and high-quality data.
  • Contribute to resource planning, budgets, and timelines for translational activities on assigned programs.
  • Develop and own comprehensive translational science strategies for early oncology programs across therapeutic modalities, supporting patient selection, target engagement, pharmacodynamics, mechanism of action, and mechanism of resistance from preclinical through Phase 1/proof-of-concept clinical studies.
  • Define and execute biomarker plans that deliver decision-quality data for go/no-go milestones, dose and schedule selection, and regulatory submissions and interactions.
  • Apply oncology expertise to generate disease-linkage data guiding indication selection and expansion.
  • Define and study mechanisms of resistance at relapse to support reverse translation, inform next-line strategies and patient enrichment, and influence early discovery efforts.
  • Lead identification, development, and analytical validation of fit-for-purpose translational assays, deploying them internally and/or through external partners.
  • Oversee clinical biomarker implementation, including sample collection strategies, laboratory manuals, biomarker sections of clinical study protocols, informed consent forms, and statistical and analysis plans for early first-in-human studies.
  • Integrate clinical biomarker analyses to enable patient selection, enrichment, and response monitoring.
  • Partner with cross-functional groups on sample management, biomarker testing, data generation, documentation, traceability, companion diagnostic pathway considerations, and regulatory expectations for analytical validation.
  • Ensure biomarker data and deliverables meet quality standards for clinical study reports, regulatory filings, and scientific publications.
  • Represent the translational medicine lead perspective on early project development teams, collaborating across oncology research, discovery, clinical development, clinical operations, and product development to integrate translational strategies throughout early drug discovery and development.
  • Influence translational strategy across the broader oncology portfolio by sharing scientific insights and establishing best practices for early programs.
  • Represent the company at scientific forums, congresses, and key opinion leader engagements as an external ambassador for the program.
  • Contribute to and ensure the quality of translational medicine clinical study reports, data reviews, interpretations, presentations, and recommendations to development teams and senior management.

Desired Qualifications

  • Experience with CTD/ctDNA platforms and liquid biopsy approaches for monitoring drug response.
  • Experience with digital pathology and artificial intelligence/machine learning integration for biomarker analyses.
  • Experience integrating multi-omic biomarkers, including flow, next-generation sequencing, proteomics, and cytokines, into clinical decision-making frameworks.
  • Scientific capability demonstrated through publications, research reports, and external presentations in translational oncology or clinical biomarkers.
  • Interpersonal skills and ability to work effectively in a matrix environment.
  • Problem-solving, critical thinking, and risk management skills with attention to scientific detail.
  • Communication, presentation, and influencing skills, including the ability to translate complex biomarker data into decision-enabling insights for cross-functional audiences.
  • Collaborative working skills and experience navigating complex multi-stakeholder environments.
  • Ability to act as an external ambassador and influence external organizations to enhance the company's scientific reputation.
  • Ability to mentor and develop scientific colleagues.

About the Company

GSK

Develops medicines, vaccines, and consumer health

GSK is a global healthcare company focused on three main areas: Pharmaceuticals, Vaccines, and Consumer Healthcare. It develops medicines, vaccines, and consumer health products to improve health outcomes worldwide. Its products address diseases in respiratory, HIV, oncology, and immuno-inflammatory areas; vaccines for influenza, shingles, and COVID-19; and over-the-counter wellness products. The company relies on substantial R&D and strategic partnerships to bring new products to market and to address health needs. Revenues come from sales of medicines, vaccines, and consumer health items, often complemented by patient support programs and collaborations with governments and biotech partners.

Company size
10,001+
Company stage
IPO
Headquarters
London, United Kingdom
Founded
1891

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