Oncology Clinical Biomarker Lead, Translational Development

Role Summary

The Clinical Biomarker Lead will be responsible for development and execution of translational strategies in solid tumor oncology for assigned programs. Act as a lead scientist to implement and deliver on biomarker strategies for clinical programs, develop reports and publications on translational data generated to support asset development and contribute to regulatory submissions. Work on cross-functional project teams to drive execution of translational/biomarker plans with disease and lab scientists, as well as members from clinical, medical, commercial, regulatory, and diagnostics. Engage with external academic collaborators/KOLs. Location options include 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 and interpretation and communicating to development teams.
• Understand external research environment and coordinate execution of Translational development deliverables with internal and external functions.
• Engage functional groups to develop, champion, implement and align biomarker strategies for development projects to support 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 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 capabilities to deliver robust translational biomarker data packages to support 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.
• 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

Required and Preferred Qualifications

• Requires comprehensive knowledge of principles, concepts and methodologies within drug discovery or clinical development
• Significant understanding of the role of translational research/medicine and clinical biomarkers in drug development
• Demonstrated knowledge of oncology and/or tumor-immunology disease biology
• Preferably strong understanding of immuno-angiogenic therapies
• Starting compensation range from $186,000-$218,000 plus incentive cash and stock opportunities (based on eligibility)