Associate Director, Neuroscience, Clinical Biomarker, Late Phases, Translational Medicine

Role Summary

Associate Director, Neuroscience, Clinical Biomarker, Late Phases, Translational Medicine lead design and execution of program-specific late development biomarker and translational plans in neuroscience. Responsible for clinical protocol support, assay selection, vendor management, data delivery and analysis, and regulatory interactions in collaboration with translational science teams and CROs.

Responsibilities

• Designs and implements program-specific late development biomarker/translational plans, aiding in the creation of clinical protocols, SAPs, SOWs, lab manuals, and interfacing with CROs 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 publications 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 to critically evaluate literature regarding assets 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 neuroscience with 7+ years of translational medicine experience.
• 5+ years of late-stage clinical biomarker experience in biotech/pharma.
• Recognized expertise in translational biomarkers in the neuroscience space.
• Deep training and education in Neuroscience required.
• Experience in late-stage drug development and activities 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, 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; demonstrates a track record of delivering results and building cross-functional networks.
• Ability to prioritize and manage time efficiently; accurate and detailed record keeping; excellent organizational skills.