Associate Director, Clinical Regulatory

Denali Therapeutics•South San Francisco, CA

15d•$215,544 - $260,822

About The Position

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. The Associate Director, Clinical Regulatory is a highly motivated and creative individual with deep and broad regulatory experience and expertise. This individual is a Global Regulatory Leader accountable for the strategic and technical regulatory leadership of one or more development programs in neurodegenerative diseases. This leader 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.

Requirements

Bachelor’s degree required. Advanced degree in life sciences strongly preferred.
7+ years of relevant work experience required, including 6+ years in regulatory affairs
Thorough understanding of drug development process and the pharmaceutical industry and healthcare environment including regulatory requirements and policy trends
Strong experience with INDs/CTAs, NDAs/BLAs/MAAs, lifecycle management, interactions with Health Authorities, developing and implementing regulatory strategies with a proven track record of significant regulatory accomplishments.
Broad strategic skill set, including creativity and effectiveness in identifying and addressing major strategic challenges (e.g., competitive landscape, challenging therapeutic areas).
Skilled in influencing, partnership, and collaboration, 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 appropriately
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

Nice To Haves

Advanced degree in life sciences strongly preferred.

Responsibilities

Accountable for developing regulatory strategy for complex development programs; leads project teams in implementing and delivering the regulatory strategy across multiple programs/indications and/or programs of increasing complexity
Responsible for identifying regulatory risk and mitigation in support of development plans
Accountable for overseeing and directly leading global Health Authority interactions
Independently executes preparation, submission, and maintenance of regulatory applications, including initial applications, routine amendments, annual reports, IND safety reports, and correspondence with global Health Authorities
Participates in cross-functional teams, providing regulatory feedback and support
Partners with external vendors in support of regulatory document preparation and submission
Maintains up-to-date knowledge of the regulatory landscape, regulations, and guidelines
Identifies and maintains leadership/ownership of non-project activities
Complies with relevant governing laws, regulations, guidelines, and Denali SOPs
Develops, manages, and mentors junior regulatory professionals and contributes to creating a culture regulatory innovation and excellence; leads direct report(s), if applicable, through annual goal setting, growth planning, adherence to company policies, maintains training compliance and provides ongoing feedback on growth, development and areas of improvement.