Director, Clinical Regulatory (Remote Eligible)

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.

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

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.