Associate Director, Clinical Regulatory

Job Detail

Job ID 524331

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.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.Key Accountabilities/Core Job 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 complexityResponsible for identifying regulatory risk and mitigation in support of development plansAccountable for overseeing and directly leading global Health Authority interactionsIndependently executes preparation, submission, and maintenance of regulatory applications, including initial applications, routine amendments, annual reports, IND safety reports, and correspondence with global Health AuthoritiesParticipates in cross-functional teams, providing regulatory feedback and supportPartners with external vendors in support of regulatory document preparation and submissionMaintains up-to-date knowledge of the regulatory landscape, regulations, and guidelinesIdentifies and maintains leadership/ownership of non-project activitiesComplies with relevant governing laws, regulations, guidelines, and Denali SOPsDevelops, 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.Qualifications/Skills:Bachelor’s degree required. Advanced degree in life sciences strongly preferred.7+ years of relevant work experience required, including 6+ years in regulatory affairsThorough understanding of drug development process and the pharmaceutical industry and healthcare environment including regulatory requirements and policy trendsStrong 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 professionalismExcellent written and verbal communication and collaboration skillsStrong ability to prioritize workload and delegate appropriatelyWell-prepared, competent, and confident when interacting with senior management,health authorities, and internal and external partnersAble to prospectively identify potential problems and to partner effectively and positively to solve issuesCompensation 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 pension, medical stipend, equity and a broad range of other benefits.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.