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Director – Oncology Early Translational Biomarkers
Job in
California, Moniteau County, Missouri, 65018, USA
Listed on 2026-07-13
Listing for:
Jobtailor
Full Time
position Listed on 2026-07-13
Job specializations:
-
Research/Development
Oncology
Job Description & How to Apply Below
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.
- 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.
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