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. The role acts as a lead scientist to implement and deliver biomarker strategies for clinical programs, develop translational data reports and publications to support asset development, and contribute to regulatory submissions. You will work on cross-functional project teams and engage with external academic collaborators and KOLs.

Responsibilities

• Integrate translational research and clinical development, developing biomarker strategies in alignment with clinical development objectives, leading efforts for data generation and interpretation and for communication to the development teams.
• Responsible for understanding external research environment, partnering with other functions both internally and externally 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.
• Productively engages with external collaborators and scientific KOLs to support translational goals.
• Communicates key biomarker program information, risks, and milestones, and manages 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
• Previous experience as Biomarker Lead for late-stage clinical trials; Experience in phases II/III required
• Requires comprehensive knowledge of principles, concepts and / or methodologies within drug discovery or clinical development
• Has 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
• Regulatory submissions drug approvals in solid tumor space also highly desirable
• 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