Associate Director/Director, Pre-Clinical Program & Alliance Management

Role: Associate Director/Director of Pre-Clinical Program and Alliance Management, overseeing operational planning, integration, and delivery of pre-clinical assets from candidate selection to IND filing. Responsibilities include developing cross-functional program plans, managing timelines, budgets, and critical path activities, and ensuring alignment with regulatory requirements, specifically FDA IND data package submission. The role also involves managing external collaborations, CROs, and licensing partners, ensuring contractual obligations are met, and supporting milestones, payments, and governance structures. The candidate will serve as the operational hub for one or more assets, coordinating research, CMC, safety/toxicology, translational sciences, and regulatory teams. Requirements: Bachelor's in a relevant scientific discipline, with 7+ years biotech/pharma experience at Associate Director level (or 10+ at Director level), including at least 3 years supporting pre-clinical program management and IND activities. Proven track record of preparing and filing INDs, knowledge of FDA data requirements, and experience managing external alliances preferred. Skills include strong organizational, communication, stakeholder influence, and proficiency with Microsoft Office; a willingness to adopt emerging AI tools is a plus. HighValue: supporting early to IND-enabled pre-clinical programs, alliance management, cross-functional coordination, experience with biologics or small molecules, and FDA regulatory interaction. Work setup: onsite in Lexington, MA, five days a week.