Director / Senior Director, Oncology Early Translational Biomarkers
Hybrid · Waltham, Massachusetts, United States or Upper Providence, Pennsylvania, United States
Job Summary
Lead translational biomarker strategy for early oncology programs (preclinical to Phase 1), defining biomarker plans, assay strategies, sample handling, and analysis to enable go/no-go decisions. Serve as the translational medicine lead across program teams, integrating preclinical data with clinical development to guide dose, patient enrichment, and endpoint selection. Oversee assay qualification/validation, data quality, and regulatory readiness; manage external CROs/diagnostics partners and collaborate across Oncology Research, Clinical Development, Diagnostics, and external stakeholders. Deliver translational updates for protocols, investigator brochures, and regulatory documentation; mentor junior scientists and contribute to capability building. Drive translational science strategy across multiple modalities, explore cutting-edge biomarker technologies (flow, NGS/FISH/PCR, IHC/IF, liquid biopsy), and ensure data quality for clinical study reports and regulatory filings. Represent translational perspectives in governance and external forums, influence portfolio decisions, and contribute to budgets and timelines for translational activities.
Required 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 biomarker applications in Oncology trials
- Expertise in cancer biology across NSCLC/SCLC, CRC, MM, and gynecological cancers; familiarity with large molecules, small molecules and immune cell engagers
- Proven track record designing and executing translational biomarker strategies in early and late-phase trials including assay development, validation, and deployment
- Hands-on experience with biomarker platforms (flow cytometry, molecular diagnostics including NGS/FISH/PCR, and IHC/IF)
- Experience leading complex multi-functional projects in a matrix environment
- Strong communication, presentation, and influencing skills; ability to translate biomarker data to decision-enabling insights
- Mentorship experience and ability to develop scientific teams
- Experience managing external partnerships (CROs, diagnostics vendors, academic collaborators) and budgeting for translational activities
- Ability to act as an external ambassador and influence external organizations to enhance scientific reputation
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