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.

Provides scientific leadership and support for safety surveillance, signal management, and benefit-risk evaluation across clinical development programs. Integrates complex safety information from clinical studies, post-marketing experience, scientific literature, and external sources to inform development strategy, regulatory interactions, and key program decisions throughout the product lifecycle. Provides safety science input to cross-functional teams on patient safety and risk management topics. Supports the implementation of pharmacovigilance processes and contributes to continuous improvement initiatives.

Key Accountabilities/Core Job Responsibilities:

• Conduct safety surveillance, signal detection, signal evaluation, and benefit-risk assessment activities for assigned development programs, integrating data from clinical studies, post-marketing experience, scientific literature, and other relevant sources to support characterization of product safety profiles.
• Contribute to product safety strategy in collaboration with Clinical Development, Regulatory Affairs, Biometrics, Clinical Operations, and other cross-functional stakeholders throughout the product lifecycle.
• Support safety contributions to regulatory submissions and health authority interactions, including NDA/BLA filings, responses to regulatory inquiries, and lifecycle management activities.
• Author and review safety deliverables, including signal assessment reports, aggregate safety reports, Risk Management Plans, Reference Safety Information, Company Core Data Sheets, Investigator's Brochures, informed consent documents, and product labeling.
• Serve as the Drug Safety representative on Study Management Teams, Study Execution Teams, and other cross-functional teams, providing safety assessments and recommendations to support program decisions.
• Present safety findings and recommendations to Safety Committees, Data Monitoring Committees, and cross-functional stakeholders to support risk-management and development decisions.
• Provide safety science input on protocol design, safety monitoring plans, case report forms, trial master file documents, and other clinical development documents to support appropriate patient safety oversight.
• Contribute to the development and improvement of pharmacovigilance processes, standards, methodologies, and tools that support safety surveillance and risk management activities.
• Share safety science knowledge and provide guidance on signal evaluation methodologies and regulatory expectations within Drug Safety and cross-functional teams.
• Represent Drug Safety in interactions with external partners, investigators, contract research organizations, and regulatory agencies on safety-related matters, as appropriate.

Qualifications/Skills:

• Healthcare professional degree required; typically BSN, MSN, RN, NP, PA, PharmD, MD, or equivalent clinical or scientific degree.
• Typically requires a minimum of 10+ years of related experience with a Bachelor's degree; or 8+ years with a Master's degree; or a PhD with 3+ years of experience; or equivalent experience.
• Demonstrated experience leading safety strategy, signal detection and evaluation, and benefit-risk assessments across multiple development programs and stages of the product lifecycle.
• Extensive experience authoring and leading safety deliverables, including signal assessment reports, DSURs, PBRERs, PSURs, Risk Management Plans, Investigator's Brochures, Reference Safety Information, and major regulatory submissions.
• Advanced knowledge of global pharmacovigilance regulations, safety surveillance methodologies, risk management principles, and safety governance processes.
• Proven ability to influence cross-functional teams and senior stakeholders through scientific expertise, sound clinical judgment, and effective communication.
• Experience in neurodegenerative diseases, rare diseases, and/or first-in-human clinical development preferred.

Salary Range: $155,000.00 to $202,000.00 . 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.

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.