Associate Director, Neuroimmunolgy Clinical Biomarker Late Stage Translational Development

Role Summary

Associate Director, Neuroimmunology Clinical Biomarker Late Stage Translational Development. Focuses on designing and executing late-stage biomarker/translational plans in neuroimmunology within Translational Development at BMS.

Responsibilities

• Designs and implements program-specific late development biomarker/translational plans, aiding in creation of clinical protocols, SAPs, SOWs, lab manuals, 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 teams as needed.
• Keeps up-to-date on relevant scientific/technical literature to apply external knowledge to internal research programs and acts as a subject-matter expert within the team to critically evaluate 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

• PhD or MD/PhD in neuroimmunology with 7+ years of translational medicine experience.
• 5+ 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; capable to apply scientific direction to projects and problems.

Skills

• Recognized expertise in translational biomarkers in neuroimmunology 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 (team collaboration, mentoring, project management).
• Accountable for timelines and deliverables; prioritizes risks and implements contingency plans.
• Effective communicator; delivers presentations within the department, governance, senior leadership, and externally as requested.
• Recognizes cross-functional issues and provides expert guidance to multi-disciplinary teams and senior management; builds cross-functional networks.
• Ability to prioritize and manage time efficiently; accurate and detailed record keeping; excellent organizational skills.

Education

• PhD or MD/PhD in neuroimmunology (as listed in Basic Qualifications).

Additional Requirements

• On-site or field requirements as per role designation; travel expectations as needed to collaborate with internal and external partners.