Director, Clinical Regulatory (Remote Eligible)

Denali Therapeutics; 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 (ESPP)

Job summary

Denali Therapeutics, located in South San Francisco, is looking for an experienced professional to develop regulatory strategies for complex programs.

The role requires 10+ years of experience in regulatory affairs, leadership in cross-functional teams, and expertise in drug development processes. Benefits include a competitive salary range of $211,000 to $258,667, healthcare coverage, and a 401k plan.

Qualifications

• Bachelor’s degree required; advanced degree in life sciences strongly preferred.
• 10+ years of relevant work experience required, including 8+ years in regulatory affairs.
• Thorough working knowledge of drug development process and regulatory requirements.

Responsibilities

• Develop regulatory strategy for complex development programs.
• Participate in cross-functional teams for regulatory feedback.
• Oversee global Health Authority interactions and submissions.
• Lead and manage regulatory teams, ensuring compliance.

Skills

Regulatory strategy development

Team leadership

Drug development knowledge

Strategic thinking

Collaboration skills

Communication skills

Education

Bachelor’s degree

Advanced degree in life sciences

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 https://www.denalitherapeutics.com/careers

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.