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

Role Summary

Associate Director, Neuroscience, Clinical Biomarker, Late Phases, Translational Medicine. Leads late-stage biomarker/translational strategies in neuroscience, integrating laboratory science, clinical trial biomarker work, and translational development to maximize therapeutic potential.

Responsibilities

• Designs and implements program-specific late development biomarker/translational plans, 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

Qualifications

• Required: PhD or MD/PhD in neuroscience with 7+ years of translational medicine experience
• Required: 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; functional area expert with skills, theoretical knowledge and experience to apply scientific direction and approach to projects and problems
• Excellent communication and leadership abilities; experience interacting with CROs and TLs; ability to manage timelines and deliverables

Skills

• 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
• Proven scientific/leadership expertise (working in teams, mentoring people, managing projects)
• Accountable for timelines and deliverables; prioritizes risks and implements contingency plans
• Regularly communicates; prepares and delivers presentations within the department, governance, and senior leadership as requested
• Ability to prioritize and manage time efficiently; accurate and detailed record keeping; excellent organizational skills

Education

• PhD or MD/PhD in neuroscience with 7+ years of translational medicine experience
• 5+ years of late stage clinical biomarker experience in biotech/pharma