Director, Clinical Regulatory (Remote Eligible)

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.

Key Accountabilities/Core Job Responsibilities

Developing and implementing regulatory strategy for complex development programs, leading project teams in implementing and delivering the regulatory strategy across multiple programs/indications and/or programs of increasing complexity

Participating in cross-functional teams to provide regulatory feedback and support, proactively assessing and communicating potential risks and mitigation opportunities

Overseeing and directly leading global Health Authority interactions, independently executing preparation, submission, and maintenance of regulatory applications, including initial applications, routine amendments, annual reports, IND safety reports, and correspondence with global Health Authorities

Partnering with external vendors in support of regulatory document preparation and submission

Leading and executing non-project regulatory activities

Maintaining up-to-date knowledge of the regulatory landscape, regulations, and guidelines and for developing thoughtful, data-driven strategies for influencing the regulatory landscape

Complying with relevant governing laws, regulations, guidelines, and Denali SOPs

Recruiting, developing, managing, and mentoring regulatory professionals; contributing to creating a culture of regulatory innovation and excellence; leading direct report(s), if applicable, through annual goal setting, growth planning, adherence to company policies, training compliance and for providing ongoing feedback on growth, development and areas of improvement.

Qualifications/Skills

Bachelor’s degree required; advanced degree in life sciences strongly preferred

10+ years of relevant work experience required, including 8+ years in regulatory affairs

Experience supervising, managing and coaching others strongly preferred

Thorough working knowledge of drug development process and the pharmaceutical industry and healthcare environment including regulatory requirements and policy trends

Extensive regulatory experience with INDs/CTAs, NDAs/BLAs/MAAs, lifecycle management, interactions with Health Authorities, leading and managing regulatory teams, developing and implementing regulatory strategies with a proven track record of significant regulatory accomplishments.

Strong strategic skill set, including creativity and effectiveness in identifying and addressing major strategic challenges (e.g., competitive landscape, challenging therapeutic areas) and the ability to balance short‑term needs with long‑term vision.

Exceptional influencing, partnership, and collaboration skills, including demonstrated ability to deliver on goals within a cross‑functional team/partnership environment with a high level of professionalism

Excellent written and verbal communication and collaboration skills

Strong ability to prioritize workload and delegate to reports

Well‑prepared, competent, and confident when interacting with senior management, health authorities, and internal and external partners

Able to prospectively identify potential problems and to partner effectively and positively to solve issues.

Salary Range: $211,000.00 to $258,667.00. 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 a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at

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.

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Worksite address

south san francisco, CA, 94083, US

Who can apply

Review the original listing for work authorization, qualifications and employer requirements.