Associate Director, Oncology Clinical Biomarker Asset Lead, Translational Development

Role Summary

The Clinical Biomarker Asset Lead will develop and execute translational strategies in solid tumor oncology for assigned programs. Lead biomarker strategy implementation for clinical programs, produce translational data reports/publications to support asset development, and contribute to regulatory submissions. Collaborate with cross-functional teams and external collaborators to drive translational/biomarker plans.

Responsibilities

• Integrate translational research and clinical development, developing biomarker strategies aligned with clinical development objectives, and lead data generation, interpretation, and communication to development teams.
• Understand external research environment and coordinate translational development deliverables with internal and external partners.
• Engage functional groups to develop, champion, implement, and align biomarker strategies for development projects supporting R&D portfolio goals.
• Define, revise, and progress translational biomarker plans with teams and matrix leadership.
• Analyze progress, solve problems, and deliver key data and interpretations essential for decision making.
• Deliver high-quality biomarker strategies for 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.
• Build productive relationships with team members across translational clinical biomarker groups.
• Interface with functional areas to ensure strategic alignment and resource identification to deliver biomarker goals.
• Engage with external collaborators and scientific KOLs to support translational goals.
• Communicate key biomarker program information, risks, and 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
• Strong understanding of translational research/medicine and clinical biomarkers in drug development
• Knowledge of oncology and/or tumor-immunology disease biology
• Solid tumor oncology knowledge with awareness of current clinical landscape and competitive scenarios
• Strong scientific background with understanding of clinical, translational, and mechanistic data and publications
• Experience with early or late-stage drug and translational development and implementing biomarker strategies
• Clinical protocol authoring and regulatory document review
• Working knowledge of biomarker platforms (genomics, gene expression, immune profiling, flow cytometry)
• Excellent data analysis and problem-solving skills
• Strong written and verbal communication skills with experience in manuscripts, publications, presentations, and regulatory submissions
• Proven leadership in global teams and managing people/projects

Skills

• Biomarker strategy development and data interpretation
• Cross-functional collaboration and project leadership
• Regulatory and translational science proficiency
• Genomics, gene expression, immune profiling, flow cytometry
• Scientific communication and publication writing

Education

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

Additional Requirements

• Location flexibility to Princeton/LVL, NJ; Summit NJ; or Cambridge, MA