Associate Director of Translational Medicine

at  BristolMyers Squibb

WORKING WITH US

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SUMMARY/SCOPE

Reporting to Senior Scientific Director Translational Medicine (TM), the TM Associate Director will be part of the late stage TM group. The individual will be responsible for TM and clinical biomarker activities to support drug development programs in neurodegeneration and neuropsychiatric indications. This individual will assume biomarker lead responsibilities such as serving as 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.

Responsibilities will include, but are not limited to, the following:

• 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

Skills/Knowledge Required

• 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
• 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
• Accurate and detailed record keeping
• Excellent organizational skills

Basic Qualifications:

• Bachelor’s Degree
• 12+ years of academic and / or industry experience

Or

• Master’s Degree
• 10+ years of academic and / or industry experience

Or

• Ph.D. or equivalent advanced degree in the Life Sciences
• 8+ years of academic and / or industry experience
• 4+ years of leadership experience

Preferred Qualifications:

• PhD or MD/PhD in neurology related field with 10+ years of translational experience
• 7+ years of late stage clinical biomarker experience in biotech/pharma

FUNCTIONAL/SCIENTIFIC/TECHNICAL SKILLS:

• Contributing to research program and business.
• Subject matter leader.
• Broad knowledge of multiple functional technologies.
• In-depth understanding of function as it relates to project.
• Functional area expert with skills, theoretical knowledge and experience to apply scientific direction and approach to projects and problems.

TASKS AND RESPONSIBILITIES:

• Completes technical assignments by designing, executing and interpreting complex experiments.
• Recommends department level strategic decisions.
• May lead scientifically on cross functional assignments.
• Manages and/or coordinates workflow on projects.
• Apply diverse scientific knowledge to assignments.
• Development of research tools.
• Interpret results.

Responsibilities will include, but are not limited to, the following:

• 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 neede