Associate Director, Oncology Clinical Biomarker Asset Lead, Translational Development

Role Summary

The Clinical Biomarker Asset Lead is responsible for the development and execution of translational strategies in solid tumor oncology for assigned programs. Acts as a lead scientist to implement and deliver biomarker strategies for clinical programs, develops reports and publications on translational data to support asset development and regulatory submissions. Works on cross-functional project teams to drive translational/biomarker plans, engages external collaborators and KOLs, and may be located in Princeton/LVL, NJ, Summit NJ, or Cambridge, MA.

Responsibilities

• Integrate translational research and clinical development, developing biomarker strategies aligned with clinical development objectives, leading data generation, interpretation, and communication to development teams.
• Understand external research environment and coordinate execution of translational development deliverables with internal and external partners.
• Engage functional groups to develop, champion, implement, and align biomarker strategies for development projects supporting overall R&D portfolio goals.
• Work with teams and matrix leadership to define, revise, and progress translational biomarker plans.
• Analyze progress, apply critical thinking, and solve problems to deliver key data and interpretations for decision making.
• Deliver high-quality biomarker strategies for understanding mechanism of action/resistance, target engagement, pharmacodynamics endpoints, and patient selection.
• Ensure biomarker plan outputs meet established project standards.
• Align biomarker strategies with clinical operational plans and functional capabilities to deliver robust translational biomarker data packages to support trials and programs.
• Build productive relationships with team members and interact with translational clinical biomarker groups.
• Interface with functional areas to ensure strategic alignment and identify resources to deliver biomarker goals.
• Engage with external collaborators and scientific KOLs to support translational goals.
• Communicate key biomarker program information, risks, milestones, and manage information flow across team members.

Qualifications

• Ph.D. in Oncology/immunology or related field.
• 5-8+ years of industry experience.
• 3-5 years in oncology/biomarkers/translational or correlative research.
• Comprehensive knowledge of principles, concepts, and methodologies within drug discovery or clinical development.
• Significant understanding of translational research/medicine and clinical biomarkers in drug development.
• Demonstrated knowledge of oncology and/or tumor-immunology disease biology.
• In-depth understanding of solid tumor oncology with knowledge of current and evolving clinical landscape.
• Strong scientific background with understanding of clinical, translational, and mechanistic data; track record of publications.
• Understanding of early or late-stage drug and translational development, including experience with implementing a biomarker strategy.
• Clinical protocol authoring and review of regulatory documents.
• Working knowledge of biomarker measurement platforms (genomics, gene expression, immune profiling, flow cytometry).
• Excellent data analysis and problem-solving skills.
• Exceptional verbal and written communication skills with experience in manuscripts/publications/reviews, scientific presentations, and regulatory submissions (INDs/NDAs).
• Proven scientific/project leadership and experience working in global teams and managing people/projects.

Skills

• Biomarker strategy development
• Translational and clinical data interpretation
• Cross-functional collaboration
• KOL engagement
• Regulatory document preparation
• Genomics and immunoprofiling techniques
• Scientific communication and publication writing

Education

• Ph.D. in Oncology, Immunology, or related field