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Director, Translational Medicine, Neurology

Bristol-Myers Squibb

Princeton NJFull TimeStaffH-1B sponsor company
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Location
Princeton NJ
Employment
Full Time
Work model
On-Site
Level
Staff
H-1B history
57 approvals (FY2023)
Posted

About this role

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Position

Summary The Director of Translational Medicine (TM) will be a translational team lead for neurological and neuropsychiatric indications and be responsible for setting strategy for translational activities including clinical biomarker activities to support drug development programs. This individual will assume translational lead responsibilities for assets such as serving as a TM representative on global program teams, biomarker representative on study teams, setting up biomarker plans for individual trials and ensuring appropriate collection and timely analysis and reporting of final biomarker data. The individual will also be responsible for answering key TM questions related to the assigned assets and diseases via collaboration with TM laboratory team and/or academic thought leaders. The successful candidate will have prior therapeutic area and late development clinical experience in biotech/pharma organizations interacting with project teams, clinical research physicians, statisticians, computational biologists, contract research organizations and translational scientists to deliver science that supports the development of medicines to patients in need.

Key Responsibilities

Designs and implements program-specific late development biomarker/translational plans, responsible for aiding in creation of clinical protocols, SAPs, SOWs, lab manual, and interfacing with CRO for execution of services, in conjunction with Biospecimen Operations and Procurement. 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 Participates in post-hoc biomarker analysis and publication efforts Supports regulatory submissions and regulatory interactions as needed   Qualifications & Experience:   PhD or MD/PhD in neuroscience with 10+ years of translational medicine experience 7+ years of late stage clinical biomarker experience in biotech/pharma Recognized expertise in translational biomarkers in neurology space Experience in late-stage drug development and activities required for and related to clinical trial initiation, maintenance and completion Strong verbal and written communication skills Experience in interacting with CROs and TLs to manage projects and timelines Proven scientific/leadership expertise (working in teams, mentoring people, managing projects) Accountable for timelines and deliverables Prioritizes risks and implements contingency plans Communicates regularly; prepares and delivers presentations within the department, to governance and senior leadership bodies, and externally as requested