Director, Clinical Regulatory

Denali Therapeutics Inc.; South San Francisco (CA); On-site; USD 211,000 - 258,667; Full time

Benefits offered by this job

401k

Healthcare coverage

Employee Stock Purchase Plan

Diverse and inclusive environment

Job summary

A leading biotechnology company in South San Francisco seeks a Director of Clinical Regulatory to oversee multiple clinical drug candidates and drive development as a regulatory project lead. The role involves overseeing global Health Authority interactions, leading project teams, and developing regulatory strategies. An ideal candidate will have at least 10 years of experience in regulatory affairs, strong strategic skills, and the ability to mentor regulatory professionals. This position offers a competitive salary and comprehensive benefits package.

Qualifications

• 10+ years of relevant work experience including 8+ years in regulatory affairs.
• Thorough knowledge of drug development process and regulatory requirements.
• Experience supervising and managing regulatory professionals.

Responsibilities

• Develop and implement regulatory strategies for complex programs.
• Participate in cross-functional teams for regulatory support.
• Oversee global Health Authority interactions and regulatory submissions.

Skills

Regulatory strategy development

Team collaboration

Regulatory submissions

Coaching and mentoring

Strategic thinking

Excellent communication

Education

Bachelor’s degree

Advanced degree in life sciences

Job description

Director, Clinical Regulatory page is loaded## Director, Clinical Regulatorylocations: South San Franciscotime type: Full timeposted on: Posted 2 Days Agojob requisition id: R-1462Neurodegenerative 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.The Director, Clinical Regulatory is a highly motivated and creative individual with deep and broad regulatory experience and expertise. This individual will be responsible for oversight of multiple clinical drug candidates in development, as well as accountable for driving development as a regulatory project lead. The Director, Clinical Regulatory, is accountable for leading and overseeing global Health Authority interactions, project team support, regulatory intelligence activities, and proposing and implementing department initiatives in our drive to defeat neurodegeneration.**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 issuesSalary 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 https://www.denalitherapeutics.com/careersThis 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.