Associate Director, Clinical Regulatory

About the role

Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through a deep commitment to degeneration biology and principles of translational medicine. As the Associate Director, Clinical Regulatory, you will serve as a Global Regulatory Leader, providing strategic and technical regulatory leadership for one or more development programs in neurodegenerative diseases.

Responsibilities

• Develop regulatory strategy for complex development programs; lead project teams in implementing and delivering the regulatory strategy across multiple programs/indications.
• Identify regulatory risk and mitigation in support of development plans.
• Oversee and directly lead global Health Authority interactions.
• Independently execute preparation, submission, and maintenance of regulatory applications, including initial applications, routine amendments, annual reports, IND safety reports, and correspondence with global Health Authorities.
• Participate in cross-functional teams, providing regulatory feedback and support.
• Partner with external vendors in support of regulatory document preparation and submission.
• Maintain up-to-date knowledge of the regulatory landscape, regulations, and guidelines.
• Identify and maintain leadership/ownership of non-project activities.
• Comply with relevant governing laws, regulations, guidelines, and Denali SOPs.
• Develop, manage, and mentor junior regulatory professionals; lead direct report(s) through annual goal setting, growth planning, and ongoing feedback.

Qualifications

• Bachelor’s degree required; advanced degree in life sciences strongly preferred.
• 7+ years of relevant work experience, including 6+ years in regulatory affairs.
• Thorough understanding of the drug development process and the pharmaceutical industry, including regulatory requirements and policy trends.
• Strong experience with INDs/CTAs, NDAs/BLAs/MAAs, lifecycle management, interactions with Health Authorities, and developing regulatory strategies with a proven track record of significant regulatory accomplishments.

Skills

• Broad strategic skill set, including creativity and effectiveness in addressing major strategic challenges (e.g., competitive landscape, challenging therapeutic areas).
• Skilled in influencing, partnership, and collaboration; demonstrated ability to deliver on goals within cross-functional teams.
• Excellent written and verbal communication and collaboration skills.
• Strong ability to prioritize workload and delegate appropriately.
• Well-prepared, competent, and confident when interacting with senior management, health authorities, and internal/external partners.
• Able to prospectively identify potential problems and partner effectively to solve issues.

Pay

Salary range: $171,000.00 to $223,000.00. Compensation depends on qualifications, skills, competencies, and experience.

Benefits

Denali offers a competitive total rewards package, including a 401k, healthcare coverage, an Employee Stock Purchase Plan (ESPP), and a broad range of other benefits. Learn more at Denali Therapeutics Careers.