Associate Director, Regulatory Project Manager

Denali Therapeutics · United States

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. This role drives the operational backbone of Denali's regulatory strategy, ensuring that every drug candidate's path from IND/CTA through BLA/NDA/MAA stays on track, on time, and aligned across functions. Acting as a trusted cross-functional partner to Regulatory Program Managers, Medical Writing, Regulatory Operations, and development SMEs, this individual anticipates risk before it becomes delay and translates complex, shifting priorities into clear, actionable plans. The role shapes how Regulatory Affairs plans and resources its work, contributing directly to Denali's ability to bring novel therapies for neurodegenerative disease to patients faster. Key Accountabilities / Core Job Responsibilities:

• Leads development and management of regulatory activity timelines across the portfolio, spanning regulatory documents, health authority interactions, and submissions, anticipating downstream risk and adjusting strategy as program priorities shift.
• Partners with Regulatory Program Managers and Program Directors to align regulatory timelines with corporate and program-level goals, resolving competing priorities across programs.
• Manages external partnerships with vendors
• Drives timely delivery from cross-functional SMEs, applying judgment to unblock complex, ambiguous issues that don't have a standard playbook.
• Supports cross-functional health authority interaction and filing team project needs, owning risk identification, mitigation planning, and timeline impact assessment in partnership with Filing Team/Health Authority Interaction Leads.
• Owns regulatory timeline templates and resourcing models, shaping Regulatory Affairs' long-range and annual budget forecasting.
• Drives regulatory initiatives and/or represents Regulatory Affairs on strategic cross-functional initiatives
• Mentors and provides technical direction to junior regulatory project management staff on complex filings, without formal supervisory responsibility.

• Typically requires a minimum of 12 years of related experience with a Bachelor’s degree; or 10 years and a Master’s degree; or a PhD with 7 years experience; or equivalent experience - and 5+ years of project/program management experience
• Typically requires demonstrated experience leading regulatory project management across INDs/CTAs and marketing applications; rare disease and/or complex filing experience preferred.
• Proficiency in Smartsheet or comparable project/resource management software.
• Demonstrated ability to lead cross-functional teams and influence senior stakeholders without direct authority.
• Strong track record identifying risk proactively and driving resolution across ambiguous, multi-stakeholder problems.