Associate Director, Oncology Clinical Biomarker Asset Lead, Translational Development

Role Summary

Associate Director, Oncology Clinical Biomarker Asset Lead, Translational Development. Responsible for development and execution of translational strategies in solid tumor oncology for assigned programs; act as a lead scientist to implement and deliver biomarker strategies for clinical programs; develop reports and publications to support asset development and regulatory submissions; work on cross-functional teams and engage external collaborators and KOLs. Location options include Princeton/LVL, NJ, Summit NJ, or Cambridge, MA.

Responsibilities

• Integrate translational research and clinical development, developing biomarker strategies in alignment 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 in support of R&D portfolio goals.
• Define, revise and progress translational biomarker plans with matrix leadership.
• Analyze progress, apply critical thinking, and deliver 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 project standards.
• Align biomarker strategies with clinical operational plans and capabilities to deliver robust translational biomarker data packages for trials and programs.
• Build productive relationships with team members interacting with the translational clinical biomarker group.
• Interface with functional areas to ensure strategic alignment and resource identification to deliver biomarker goals.
• Engage with external collaborators and KOLs to support translational goals.
• Communicate biomarker program information, risks, and milestones; 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.

Required and Preferred Qualifications

• 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.