*Note: exact level depending on experience*
Position Summary:
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
Key Responsibilities
Portfolio Strategy:
- 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.
Team Oversight: 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.
Cross-Functional Integration: 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.
Patient Stratification & Precision Medicine: 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).
Data Interpretation & Reverse Translation: 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.
Regulatory & External Engagement: Author and review the translational sections of key regulatory documents (INDs, IBs, clinical study reports).
Qualifications & Experience:
- Education: an advanced degree in oncology, immunology, molecular biology, pharmacology, or a related field. M.D., M.D./Ph.D., or Ph.D. preferred.
- Industry Experience: 8 to 12+ years of progressive leadership experience in translational medicine and early clinical development within the biotech or pharmaceutical industry.
- Therapeutic Expertise: 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.
- Translational Mastery: 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.
- Leadership: Demonstrated ability to build, manage, and inspire high-performing scientific teams in a fast-paced, highly matrixed, and collaborative environment.
- Regulatory Fluency: Strong working knowledge of global regulatory requirements for translational endpoints and diagnostic development.
- Analytical skills - R Programming and Python to support bioanalysis is desirable. Data wrangling and data manipulation. Understanding of data transfer requirements.
Pay & Benefits:
The anticipated base salary for this position ranges from $200,000 to $270,000 depending on relevant skills, competencies, experience, and education. In addition, this position is eligible for target bonus, long-term-incentives, 401k retirement savings plan with company match, and a comprehensive benefits package which includes medical, dental, vision, life, and disability insurance.
