Oncology Clinical Biomarker Lead, Translational Development

Role Summary

Lead scientist responsible for development and execution of translational biomarker strategies in solid tumor oncology for assigned programs. Act as a lead for implementing and delivering biomarker strategies for clinical programs, developing reports and publications on translational data to support asset development and regulatory submissions. Will work on cross-functional project teams with disease and lab scientists, and with clinical, medical, regulatory, diagnostics, and external collaborators/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, partnering with internal and external functions to coordinate the execution of Translational development deliverables.
• Engages functional groups to develop, champion, implement and align biomarker strategies for development projects in support of the overall R&D portfolio goals.
• Effectively engages with teams and matrix leadership to define, revise and progress translational biomarker plans.
• Continually analyzes progress, engages in critical thinking, and asserts strong problem-solving towards delivering key data and interpretations essential for decision making.
• Delivers high quality biomarker strategies for understanding mechanism of action/resistance, target engagement, pharmacodynamics endpoints and patient selection.
• Ensures the output of the biomarker plans meets established project standards.
• Engages team members to ensure alignment of biomarker strategies with clinical operational plans and with functional area capabilities to execute and deliver on robust translational biomarker data package to support trial and program
• Builds productive relationships with team members that interact with the translational clinical biomarker group.
• Effectively interfaces with functional areas to ensure strategic alignment and to identify resources needed to deliver on biomarker goals.
• Communicates key biomarker program information, risks, and milestones, and manages information flow across team members.

Qualifications

• Required: Ph.D. in Oncology/immunology or related field.
• Required: 5-8+ years of industry experience.
• Required: 3-5 years in oncology/biomarkers/translational or correlative research.
• Required: Requires comprehensive knowledge of principles, concepts and/or methodologies within drug discovery or clinical development.
• Required: Has significant understanding of the role of translational research/medicine and clinical biomarkers in drug development.
• Required: Demonstrated knowledge of oncology and/or tumor-immunology disease biology.
• Preferred: Preferably has strong understanding of immuno-angiogenic therapies.

Skills

• In-depth understanding of solid tumor oncology with knowledge of current and evolving clinical landscape and competitive scenarios
• Strong scientific background with understanding of clinical, translational, and mechanistic data with proven track record of publications
• Understanding of early or late-stage drug and translational development process; including experience with implementing a biomarker strategy
• Clinical protocol authoring and review of regulatory documents
• Working knowledge of technological platforms covering biomarker measures including but not limited to genomics, gene expression, immune profiling, and flow cytometry
• Excellent data analysis and problem-solving skills
• Exceptional verbal and written communication skills with experience in developing written documents such as primary manuscripts/publications/reviews, scientific presentations and regulatory submissions (INDs/NDAs) with ability to synthesize complex scientific concepts into simple communication points
• Proven scientific/project leadership expertise and experience working in global teams and managing people/projects