Associate Director, Oncology Clinical Biomarker Asset Lead, Translational Development

About This Role

This role is responsible for developing and executing translational strategies in solid tumor oncology for assigned programs. The individual will act as a lead scientist to implement biomarker strategies, develop reports and publications on translational data, and contribute to regulatory submissions. This position drives the execution of translational/biomarker plans by working with cross-functional teams and engaging external academic collaborators.

Responsibilities

• Integrate translational research and clinical development, developing biomarker strategies in alignment with clinical development objectives
• Lead efforts for data generation and interpretation and for communication to the development teams
• Understand external research environment, partnering with other functions both internally and externally to coordinate the execution of Translational development deliverables
• Engage functional groups to develop, champion, implement and align biomarker strategies for development projects
• Engage with teams and matrix leadership to define, revise and progress translational biomarker plans
• Analyze progress, engage in critical thinking, and assert strong problem-solving towards delivering key 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 the output of the biomarker plans meets established project standards
• Productively 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

Requirements

• Ph.D. in Oncology/immunology or related field
• 5-8+ years of industry experience
• 3-5 years in oncology/biomarkers/translational or correlative research
• Previous experience as Biomarker Lead for late-stage clinical trials; Experience in phases II/III
• Comprehensive knowledge of principles, concepts and / or 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
• 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)
• Proven scientific/project leadership expertise and experience working in global teams and managing people/projects

Qualifications

• Ph.D. in Oncology/immunology or related field
• 5-8+ years of industry experience, with 3-5 years in oncology/biomarkers/translational or correlative research and previous experience as Biomarker Lead for late-stage clinical trials (Phases II/III)

Nice to Have

• Regulatory submissions drug approvals in solid tumor space

Skills

* Required skills

Benefits