- Lead cross-functional Biomarker Teams to develop and execute biomarker/diagnostic strategies and to generate, analyze, and interpret data from clinical studies
- Direct the development, outsourcing, and validation of clinically applicable biomarker assays including pharmacodynamic, predictive, prognostic, safety and other biomarkers for oncology programs
- Identify, establish and oversee external collaborations with key opinion leaders, academic sites, and CROs to advance our understanding of disease pathways and prognostic/predictive biomarkers
- Collaborate with Research Biology, Clinical Research, Bioinformatics and Biostatistics functions to create synergy in developing biomarker strategies and translational approaches
- Strong experimental background and experience in hypothesis-driven biological/translational research with demonstrated ability to execute well-designed experiments in tumor immunology
- Must be able to work independently and effectively on multiple programs in a fast-paced matrixed environment
- Excellent collaboration, communication, and interpersonal skills are required to engage and be productive within a high achieving team environment
- Must be team and detail-oriented, motivated, and results focused.
- Demonstrated expertise in immunolog and/ or oncology clinical development
- Ability to integrate complex scientific ideas, generate testable hypotheses, and execute
- Analysis and interpretation of biomarker data in preclinical and clinical setting
- Broad understanding of drug discovery and development in both early and late stage
- development and familiarity with regulatory approval process.
- Experience with the discovery, characterization, clinical validation and utilization of innovative biomarkers and potential diagnostics.
- Knowledge of biomarker discovery and development, assay development/validation, clinical discovery of biomarkers, and MoA/translational research.
- Authoring of biomarker strategy documents, biomarker specific portion of clinical protocols, and regulatory documents
- Broad experience in technical aspects of companion diagnostics development
- Proven scientific/leadership expertise (working in teams, managing people/projects commensurate with level)
- Proven publication record
- Strong verbal and written communication skills
- Understanding of IP, contracting terms and provisions
PhD and/or post-doctoral training in the area of immunology and/ or oncologyor other related medical science field with a minimum of 10 years of directly relevant biotechnology or pharmaceutical industry experience. Candidate must be detail-oriented with excellent organizational skills. Must be a highly flexible, results oriented, independent self-starter who enjoys working in a fast paced dynamic multi-disciplinary environment.