Director, Safety Science

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.

We are seeking a highly skilled Director of Safety Science to lead clinical and post-marketing safety surveillance, ensuring patient safety and regulatory compliance. This role directs safety signal and risk management activities, oversees adverse event reporting, and provides safety input for clinical and regulatory documents. Responsibilities include preparing global risk management plans, safety regulatory submissions (e.g., DSURs, PADERs), and supporting regulatory interactions, audits, and inspections. The position represents Drug Safety in internal and external meetings, tracks safety-related decisions, and maintains standard operating procedures (SOPs) to uphold best practices in pharmacovigilance.

Key Accountabilities/Core Job Responsibilities:

• Responsible for the strategy and implementation of the program-specific clinical and post-marketing safety surveillance to ensure patient safety and regulatory compliance.
• Leads Safety Management Team(s) and directs all safety signal and risk management activities for assigned products.
• Contributes to review of adverse event reports to ensure the accuracy, integrity and completeness of information.
• Provide safety input to protocols, statistical analysis plans, clinical study reports, investigator's brochure, reference safety information, informed consent documents, and other clinical regulatory documents; prepare/review safety sections of new drug applications and other regulatory filings.
• Ensures local and global risk management plan preparation and execution throughout a product's lifecycle.
• Responsible for the completion of safety regulatory submissions such as development safety update report (DSUR) and other aggregate safety reports for regulatory agencies worldwide.
• Tracks implementation of SMT and DSC decisions.
• Support responses to questions from regulatory authorities, regulatory agency audits and inspections, corrective action plans, and PV vendor oversight in collaboration with Safety Operations.
• Represents Drug Safety at internal (e.g. governance and leadership teams) and external meetings (e.g. regulatory authority), attending cross-functional or project-specific team meetings to provide safety expertise, as needed.
• Drafts and maintains standard work practice documents including standard operating procedures (SOPs), work instructions, forms and templates.
• Performs other tasks and assignments as needed.

Qualifications/Skills:

• Advanced degree in health and related fields required.
• At or near 10 years of relevant work experience to include 7+ years in drug safety and pharmacovigilance and a track record of successful deliveries of core safety/PV activities in cross-functional safety teams.
• Strong working knowledge of global PV requirements (e.g., US Code of Federal (CFR) regulations; European Union (EU); Guideline on Good Pharmacovigilance Practices (GVP) and ICH Guidelines.
• Strong interpersonal skills that facilitate collaboration across functions to reach consensus on safety topics.
• Willingness to teach and to learn.

Salary Range: $213,000.00 to $265,000.00 . 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

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.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.