Sr Principal Scientist , Cardiovascular, Translational Dev - MA

Position Summary

Translational Development is part of the Global Research organization in BMS and leads late-stage clinical, pharmacological and translational research and development activities for the pipeline and supports late-stage portfolio for regulatory, translational development and life cycle management. Translational Development drives strategy across core therapeutic areas at BMS including hematology, oncology, immunology, cardiovascular and neuroscience. This group integrates laboratory science, clinical trial/biomarkers and asset development as well as disease research to maximize the potential of BMS current and future therapeutics.

Key Responsibilities

• Designs and implements program-specific development biomarker/translational plans
• Aids in creation of clinical protocols, SAPs, SOWs, lab manual, and interfacing with CRO for execution of services
• Determines appropriate assays and vendors for clinical biomarkers, and manages outsourcing of biomarker assay development and validation partnering with Translational Sciences colleagues when applicable
• Manages clinical biomarker data delivery and analysis and associated timelines by working with relevant internal functions and CROs
• Prepares and delivers internal and external translational/biomarker presentations
• Maintains timelines for biomarker data related publication through interaction with Medical Communications and Publication team as needed
• Keeps up-to-date on relevant scientific/technical literature in order to applying external knowledge to internal research programs as appropriate and acts as a subject-matter expert within the team to critically evaluate the literature regarding the asset and disease biology
• Works with TM laboratory scientists and academic TLs to address nonclinical translational questions as needed
• Participates/leads post-hoc biomarker analysis and publication efforts
• Supports regulatory submissions and regulatory interactions as needed
• Supports Diagnosis (PDx) biomarker assay development through collaboration with precision medicine group

Qualifications & Experience

• PhD with 5–8+ years of translational medicine and clinical biomarker experience, including 5+ years supporting early- and/or late-stage clinical programs in biotech or pharma
• Recognized expertise in translational biomarkers in cardiovascular or related disease areas, with experience in drug development and clinical trial initiation, conduct, and completion
• Experience interacting with CROs and thought leaders to manage projects, timelines, and deliverables
• Demonstrated scientific and project leadership experience, including working in cross-functional teams, mentoring, and managing projects, with the ability to identify risks and implement contingency plans
• Experience mining and interpreting datasets in collaboration with bioinformaticians to understand mechanism of action, disease pathophysiology, or patient segmentation hypotheses
• Strong communication skills, including preparing and delivering presentations within the department, to governance and senior leadership, and externally as needed; recognizes and communicates cross-functional issues across the organization
• Ability to support multiple projects in a fast-paced, collaborative environment, with strong organizational skills, attention to detail, and accurate record keeping