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Translational Medicine Lead

2 months ago


Summit, New Jersey, United States Bristol-Myers Squibb Full time
About the Role

We are seeking a highly skilled Senior Principal Scientist to join our Translational Medicine team at Bristol-Myers Squibb. As a key member of our late-stage team, you will be responsible for leading clinical biomarker activities to support drug development programs in multiple diseases in neurology and neuropsychiatry.

Key Responsibilities
  • Design and implement program-specific biomarker/translational plans
  • Responsible for aiding in creation of clinical protocols, SAPs, SOWs, lab manual, and interfacing with CRO for execution of services
  • Determine appropriate assays and vendors for clinical biomarkers, and manage outsourcing of biomarker assay development and validation
  • Manage clinical biomarker data delivery and analysis and associated timelines
  • Prepare and deliver internal and external translational/biomarker presentations
  • Maintain timelines for biomarker data related publication
  • Keep up-to-date on relevant scientific/technical literature and apply external knowledge to internal research programs
  • Work with TM laboratory scientists and academic TLs to address nonclinical translational questions
  • Participate in post-hoc biomarker analysis and publication efforts
  • Support regulatory submissions and regulatory interactions as needed
Requirements
  • Understanding of late-stage drug development
  • Experience in activities required for and related to clinical trial initiation, maintenance, and completion
  • Experience in interacting with CROs and TLs to manage projects and timelines
  • Proven scientific/leadership expertise, including working in teams, mentoring people, managing projects
  • Accountable for timelines and deliverables
  • Prioritizes risks and implements contingency plans
  • Communicates regularly and prepares and delivers presentations within the department, to governance and senior leadership bodies, and externally as requested
  • Recognizes cross-functional issues and communicates within the larger organization
  • Provides expert guidance to multi-disciplinary teams and senior management
  • Has a track record of delivering results, driving continuous improvements, and building effective cross-functional networks
  • Ability to prioritize and manage time efficiently
  • Strong verbal and written communication skills
  • Accurate and detailed record keeping
  • Excellent organizational skills
Education and Experience
  • Bachelor's Degree, 10+ years of academic and/or industry experience
  • Master's Degree, 8+ years of academic and/or industry experience
  • Ph.D. or equivalent advanced degree in the Life Sciences, 6+ years of academic and/or industry experience
  • 2+ years of leadership experience
Preferred Qualifications
  • Ph.D. in neuroscience or related field, 8+ years of academic/biotech experience
  • Minimum 3 years of clinical biomarker experience