Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
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The Director of Biomarker Assay Development will be responsible for oversight of the Technology Core responsible for design, development, & optimization of cutting edge clinic-ready biomarker assays for target engagement and pharmacodynamics in the field of Oncology in alignment with the biomarker and clinical development strategy for all therapeutic candidates within the Tumor Microenvironment Thematic Research Center (TME TRC).Roles & Responsibilities
Scope of role and responsibilities:
- Lead the Technology Core consisting of 10-15 scientists who effectively collaborate with other TME Modulation TRC discovery and translational biology colleagues (including discovery biotherapeutics, translational medicine, early clinical development and project leadership) to develop high quality clinic-ready target engagement and pharmacodynamics (proximal and distal) biomarker assays for all development candidate programs within the TRC.
- Ensures the output of the biomarker assay development meets established program standards (within budget, on schedule, compliance, etc.), while also looking for opportunities to streamline progress without compromising quality.
- Working with Early Clinical Development and Project Leadership colleagues, proactively provides insight into novel ways to assess target engagement and pharmacodyamic assays to enable early understanding of emerging drug profiles.
- Communicates key biomarker program information, risks, and milestones, and manage information flow across key stakeholders including therapeutic area leadership, functional leads and team members.
- Development of clinic-ready patient selection and PD assays
- Execution of exploratory biomarker assays
- TRC-dedicated NGS/Gene manipulation
- TRC-dedicated IHC/histology
- TRC-dedicated flow cytometry core lab
- MD, PhD or MD/PhD or equivalent advanced biology degree with 8+ years of experience in the drug development and translational medicine.
- Strong technical knowledge and understanding of the role of translational research/medicine and clinical biomarkers in drug development.
- Extensive technical experience and expertise in the design and generation of cutting edge clinic-ready biomarker assays in the field of Oncology.
- Ability to effectively cooperate and partner with others within BMS and external providers.
- Experience in leading strong technical team of scientists.
Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.
Associated topics: design, engineering, manufacture, product, product manager, production, program manager, quality