Associate Director, Regulatory Project Manager

Denali Therapeutics Inc; South San Francisco (CA); On-site; USD 171,000 - 223,000; Full time

Benefits offered by this job

401k

Healthcare coverage

ESPP

Other benefits

Job summary

Denali Therapeutics Inc is seeking an experienced Regulatory Project Manager to drive the regulatory strategy and timelines across a portfolio of neurodegenerative disease programs. You will partner with Regulatory Affairs, Medical Writing, Operations, and development SMEs to ensure submissions stay on track and aligned with program goals.

The role emphasizes proactive risk identification, cross-functional collaboration, and timely vendor coordination, with mentorship of junior staff and support

Qualifications

• Requires a strong background in regulatory project management across INDs/CTAs and marketing applications.
• Experience leading cross-functional teams and influencing senior stakeholders.
• Proven ability to identify risk proactively and drive resolution in complex programs.
• Proficiency with project management tools and documentation standards.

Responsibilities

• Lead development and management of regulatory activity timelines across the portfolio.
• Partner with program managers to align regulatory timelines with corporate goals.
• Manage external partnerships with vendors.
• Unblock complex issues and ensure timely regulatory submissions.
• Support health authority interactions and filing team needs, including risk assessment.
• Own regulatory timeline templates and resourcing models; contribute to budget forecasting.
• Drive regulatory initiatives and participate in cross-functional programs.
• Mentor junior regulatory project management staff.

Skills

Regulatory project management

Cross-functional leadership

Risk identification

Timeline management

Vendor management

Regulatory submissions

INDs/CTAs filings

Smartsheet

Education

Bachelor's degree

Master's degree

PhD

Tools

Smartsheet

Job description

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.

Qualifications/Skills:

• 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.

Salary Range: $171,000.00 to $223,000.00 .

Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience.

Denali offers a competitive total rewards package, which includes:

• 401k
• healthcare coverage
• ESPP
• broad range of other benefits

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.

Denali is committed to its core company value of unity by creating a diverse and inclusive environment.

We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

"Life at Denali" is a living reflection of our values: trust, unity, grit and growth. These are not just words we share—they shape how we show up, collaborate and push boundaries together. From the lab to the community, across functions and milestones, our culture thrives on shared purpose and relentless pursuit.