Senior Principal Scientist, Neuroscience, Clinical Biomarker, Late Phases, Translational Medicine

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 apply 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.
• Supports regulatory submissions and regulatory interactions as needed.

Qualifications & Experience

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