Director / Senior Director, Translational & Clinical Biomarkers

We are seeking an experienced and highly motivated Director or Senior Director of Translational & Clinical Biomarkers to lead translational and biomarker strategy and execution across discovery and development programs. This individual will play a critical role in advancing our lead development candidate and emerging pipeline by evolving and implementing translational and clinical biomarker strategies that inform mechanism of action, patient selection, pharmacodynamic response, and clinical development decisions.

This is a highly visible and impactful role at the interface of discovery biology, translational science, and clinical development. The successful candidate will provide scientific and strategic leadership for biomarker activities from early discovery through clinical proof-of-concept, working closely with internal teams and external collaborators to drive data-driven development strategies.

The ideal candidate combines deep scientific expertise in oncology biomarkers and translational medicine with strong cross-functional leadership and operational skills. This individual must be comfortable operating in a fast-paced, entrepreneurial biotech environment and capable of balancing scientific rigor with pragmatic execution.

This role offers substantial growth opportunities as the company expands its pipeline and translational development capabilities.

Key Responsibilities:

Translational & Biomarker Strategy

· Lead translational and clinical biomarker strategy across discovery and development programs

· Develop and implement biomarker plans to support target engagement, mechanism of action, pharmacodynamic response, patient stratification, and resistance monitoring

· Guide biomarker integration into preclinical and clinical development strategies by identifying and validating predictive and pharmacodynamic biomarkers

· Drive translational approaches that link preclinical findings to clinical hypotheses and development decisions

· Contribute to indication selection, patient enrichment, and precision medicine strategies

Clinical Development Support

· Partner closely with clinical development, regulatory and biostatistics teams to integrate biomarkers into clinical trials

· Support design and implementation of biomarker components of early clinical studies, including first-in-human and proof-of-concept trials

· Oversee biomarker assay strategy, sample management, data generation, and interpretation across clinical studies

· Contribute to clinical protocol development, biomarker analysis plans, and translational study design

· Interpret and communicate complex biomarker and translational datasets to cross-functional teams and senior leadership

· Identify translational risks and opportunities to support efficient clinical development progression

Assay Development & External Collaboration

· Provide strategic oversight of biomarker assay development, validation, and implementation using tissue-, blood-, and molecular-based platforms

· Manage external CROs, laboratory partners, academic collaborators, and technology providers supporting biomarker activities

· Ensure high-quality execution, timelines, budgets, and deliverables across external collaborations

· Stay current with emerging technologies, regulatory and scientific advances in translational oncology, biomarker science, and precision medicine

· Contribute to development of scalable biomarker and translational infrastructure and best practices as the company grows

Regulatory & Strategic Contribution

· Contribute to regulatory submissions and interactions related to biomarker and translational strategies

· Support translational and biomarker sections of INDs, briefing documents, study reports, and regulatory responses

· Provide strategic input into portfolio prioritization, clinical development planning, and overall R&D strategy

· Serve as a scientific thought partner to executive leadership and cross-functional program teams

Qualifications

· PhD, MD, PharmD, or equivalent advanced degree in oncology, molecular biology, translational medicine, immunology, pathology, or related discipline

· 8 years (Director) or 12 years (Senior Director) of biotechnology or pharmaceutical industry experience

· Demonstrated experience supporting oncology drug discovery and development programs through IND-enabling stages, early and late clinical development

· Deep understanding of translational science, oncology biomarkers, precision medicine, and clinical biomarker development

· Experience developing and implementing biomarker strategies in early clinical development

· Familiarity with tissue- and blood-based biomarker platforms, including genomics, proteomics, ctDNA, IHC, flow cytometry, or related technologies

· Strong understanding of biomarker regulatory considerations and clinical trial integration

· Experience managing external CROs, laboratory partners, and scientific collaborations

· Excellent communication, presentation, and cross-functional leadership skills

· Demonstrated ability to influence strategy and decision-making in a matrixed environment

· Comfortable operating in a fast-paced, entrepreneurial biotech environment

Preferred

· Experience in precision oncology and targeted therapies strongly preferred

· Experience supporting first-in-human studies and translational clinical programs

· Familiarity with computational biology, bioinformatics, or multi-omics data integration approaches

· Experience with companion diagnostic strategy and development is a plus

· Experience working in small or emerging biotech companies strongly preferred

· Experience collaborating with global or China-based external partners is a plus

Personal Competencies

· Strong scientific rigor and strategic thinking

· High level of ownership and accountability

· Collaborative and solutions-oriented mindset

· Ability to navigate ambiguity and evolving priorities

· Strong communication and stakeholder-management skills

· Excellent judgment and ability to balance detail with big-picture thinking

· Capable of building trust across scientific, operational, and executive teams

· Passion for advancing innovative therapies for patients with cancer

Why This Role Is Unique

· Work directly with executive leadership and leading scientific innovators

· Shape translational and biomarker strategy for a differentiated oncology pipeline

· Influence key clinical development and precision medicine decisions across multiple programs

· Help build core translational capabilities and infrastructure within a growing biotech company

· Grow into broader translational and development leadership responsibilities as the company expands