Senior Director, Clinical Biomarkers

Vividion Therapeutics, Inc•San Diego, CA

3d•$200,000 - $270,000•Onsite

About The Position

This role will champion and support bidirectional translational medicine strategy, ensuring that discoveries are effectively translated into clinical development while clinical findings are systematically reverse-translated to inform discovery research, preclinical models, biomarker strategies, and the design of future clinical studies. The candidate will serve as the translational lead across multiple programs, partnering closely with Discovery Biology, Pharmacology, Toxicology, Clinical Development, Bioinformatics, Clinical Operations and Regulatory. The role requires a highly collaborative leader with deep expertise in translational science, biomarker strategy, human disease biology, and precision medicine.

Requirements

An advanced degree in oncology, immunology, molecular biology, pharmacology, or a related field. M.D., M.D./Ph.D., or Ph.D. preferred.
8 to 12+ years of progressive leadership experience in translational medicine and early clinical development within the biotech or pharmaceutical industry.
Deep domain knowledge in Oncology is required; experience in immunology is highly desirable.
Familiarity with small molecule modality, targeted cancer therapies, covalent inhibitors, or novel mechanisms of action (e.g., protein degradation, allosteric modulation) is a distinct advantage.
Proven track record of developing molecular and cellular assay strategies (e.g., genomics, proteomics, flow cytometry, IHC) and successfully integrating them into human clinical trials to drive decision-making.
Demonstrated ability to build, manage, and inspire high-performing scientific teams in a fast-paced, highly matrixed, and collaborative environment.
Strong working knowledge of global regulatory requirements for translational endpoints and diagnostic development.
R Programming and Python to support bioanalysis is desirable. Data wrangling and data manipulation. Understanding of data transfer requirements.

Nice To Haves

Experience in immunology is highly desirable.
Familiarity with small molecule modality, targeted cancer therapies, covalent inhibitors, or novel mechanisms of action (e.g., protein degradation, allosteric modulation) is a distinct advantage.
R Programming and Python to support bioanalysis is desirable. Data wrangling and data manipulation. Understanding of data transfer requirements.

Responsibilities

Develop and lead integrated translational medicine strategies across discovery, IND-enabling, and clinical-stage programs.
Define translational plans that maximize the probability of technical, clinical, and regulatory success for first-in-class assets.
Establish translational milestones supporting efficient progression from target validation through clinical proof-of-concept.
Support reverse translational medicine efforts by integrating emerging clinical observations with preclinical research to continuously refine biological understanding and therapeutic hypotheses.
Translate clinical efficacy, safety, biomarker, PK/PD, and patient heterogeneity data into mechanistic hypotheses that inform new preclinical experiments and platform capabilities.
Partner with Discovery Research to design and prioritize follow-up studies that investigate mechanisms of response, resistance, toxicity, target biology, and disease progression observed in clinical studies.
Drive an iterative bench-to-bedside-and-back approach that enables continuous learning across the portfolio and accelerates first-in-class drug development.
Utilize clinical data to refine target product profiles, patient selection strategies, biomarker hypotheses, and future development plans.
Collaborate with Clinical Development and Biostatistics to ensure translational learnings from ongoing and completed studies directly influence the design of subsequent clinical trials, including patient populations, endpoints, biomarker incorporation, dose optimization, and combination strategies.
Lead multidisciplinary data review meetings to integrate clinical, biomarker, imaging, genomic, and pharmacology data into actionable development decisions.
Establish a framework for systematic knowledge generation and cross-program learning, leveraging insights across the company's platform to improve future discovery and development efforts.
Lead, mentor, and support the translational science functions, including the teams responsible for developing and deploying clinical biomarkers and specific assays to measure target engagement, PD, and mechanism of action in human trials.
Partner closely with Clinical Development, Clinical Pharmacology, Discovery Biology, Biostatistics, and Regulatory Affairs to develop clinically testable hypotheses and integrate translational endpoints into clinical study protocols and model-informed drug development plans.
Champion the development of molecular signatures, companion diagnostics (CDx), and strategic patient selection criteria, particularly for mutation-driven oncology programs (e.g., MSI-positive cancers, RAS-driven tumors).
Direct the analysis of complex translational data to inform critical dose-escalation decisions, elucidate mechanisms of resistance, and provide reverse-translational insights back to the discovery engine to fuel the next generation of targets.
Author and review the translational sections of key regulatory documents (INDs, IBs, clinical study reports).