Denali Therapeutics brings the power of biotherapeutics to the whole body, including the brain. We discover, develop and deliver medicines for people living with serious diseases. Backed by GV.
About the role
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.
What they're looking for
- 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
- This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future
More about this role
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...
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