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.