Vice President, Translational Medicine & Clinical Biomarkers
BioSpace · Brisbane, CA · Yesterday
OTHRFull-time
Responsibilities
- Define and own the enterprise-wide translational medicine and clinical biomarker strategy across Nurix’s pipeline, integrating insights from discovery through Phase II/III to inform portfolio prioritization and investment decisions.
- Design and implement predictive biomarker strategies and translational plans to support indication selection and patient enrichment for degrader therapies.
- Serve as a standing member of the R&D leadership team and program governance committees; provide executive-level input on clinical development strategy, indication selection, dose/schedule decisions, and precision medicine positioning.
- Translate the unique biology of targeted protein degradation into rigorous translational hypotheses, from degrader-specific target engagement biomarkers to modality-specific patient stratification strategies.
- Represent Nurix in external scientific forums, KOL engagements, investigator meetings, and competitive intelligence activities; contribute to business development diligence on potential partnerships and in-licensing candidates.
Translational Science & Biomarker Development
- Oversee the full lifecycle of biomarker program development, from preclinical discovery and assay feasibility through clinical validation, implementation, and reporting.
- Ensure scientific rigor and regulatory defensibility at each stage.
- Direct design and execution of pharmacodynamic, predictive, prognostic, and safety biomarker strategies for each program; establish clear criteria for biomarker-driven decision gates.
- Integrate advanced translational data modalities, ctDNA/ctRNA, single-cell sequencing, spatial transcriptomics, computational pathology, and multiplex imaging into Nurix’s precision medicine.
- Partner with Discovery Biology to build translationally anchored preclinical models and IND-enabling data packages that de-risk clinical hypotheses.
- Lead clinical biomarker data interpretation and synthesis across programs; translate complex datasets into actionable insights for clinical teams, executives, and regulatory agencies.
Clinical Integration & Regulatory Partnership
- Provide scientific leadership for translational and biomarker content in clinical protocols, Investigator Brochures, clinical study reports, and regulatory submissions (INDs, BLAs, briefing documents).
- Shape biomarker regulatory strategy in close collaboration with Regulatory Affairs; represent translational science in FDA and EMA interactions, including pre-IND and End-of-Phase meetings.
- Partner with Clinical Pharmacology on integrated PK/PD modeling, dose-response biomarker analysis, and mechanism-based endpoint selection.
- Collaborate with Biostatistics and Data Science on statistical analysis plans, integrated translational datasets, and exploratory analyses that support publication and regulatory strategy.
- Provide leadership in companion diagnostic (CDx) strategy, including CRO/IVD partner selection and regulatory co-development planning where applicable.
Operational Excellence & External Partnerships
- Define and manage the translational medicine operating model, including infrastructure, technology platforms, and quality standards appropriate to Nurix’s stage and pipeline breadth.
- Evaluate, select, and govern CRO, central laboratory, and academic collaborative partnerships for biomarker assay development and clinical execution; ensure scientific and contractual accountability.
- Develop and manage the translational medicine budget and resource allocation; provide forward-looking investment guidance aligned with clinical timelines and portfolio priorities.
Team Leadership & Organizational Development
- Build, inspire, and develop a high-performing team of translational scientists and biomarker specialists; set clear goals, cultivate scientific rigor, and support career growth.
- Define team structure, roles, and growth pathways appropriate to Nurix’s pipeline stage; attract and retain top-tier scientific talent in the Bay Area biopharmaceutical market.
- Champion cross-functional collaboration and a culture of scientific excellence, intellectual curiosity, and patient focus within the team and across the broader organization.
Requirements
- Ph.D. in Immunology, Oncology, Biochemistry, Cell Biology, or a closely related life sciences discipline required; MD/Ph.D. strongly preferred.
- Postdoctoral training or equivalent advanced research experience in translational or clinical science is highly valued.
- 15+ years of progressive experience in translational medicine and/or clinical biomarker research within the pharmaceutical or biopharmaceutical industry, with meaningful tenure in oncology.
- Minimum 10 years in a senior leadership role (Sr. Director level or above) with direct management of scientific staff and function-level accountability for deliverables and budget.
- Demonstrated track record of leading translational programs from IND through proof-of-concept (Phase I/II), including first-in-human study design and execution.
- Experience leading or meaningfully contributing to Phase III biomarker programs, regulatory submissions, and health authority interactions (FDA, EMA).
- Proven ability to evaluate, select, and govern external CRO, central laboratory, and academic partnerships in a biomarker development context.
- Experience presenting to and influencing executive leadership, Boards, investors, or senior regulatory agencies preferred.
Preferred Qualifications
- Direct experience with targeted protein degradation (PROTACs, molecular glues) or other emerging modalities, including translational challenges specific to novel mechanisms of action.
- Experience in both oncology and immunology/inflammatory disease therapeutic areas, reflecting Nurix’s evolving pipeline scope.
- Demonstrated experience building a translational medicine or clinical biomarker function from early stage, including infrastructure, platform selection, SOPs, and team design.
- Familiarity with advanced computational and AI-driven approaches in translational science, including patient stratification, multi-omic integration, and machine learning-based biomarker discovery.
- Publication record as senior or corresponding author; participation in scientific advisory boards or external translational medicine working groups.