Director, Clinical Regulatory

Denali Therapeutics•South San Francisco, CA

17d

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 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.

Requirements

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

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.