Senior Scientist, Safety Science

Denali Therapeutics•South San Francisco, CA

6d•$155,000 - $202,000

About The Position

Denali Therapeutics is a biotechnology company focused on developing breakthrough therapies for neurodegenerative diseases. This role provides scientific leadership and support for safety surveillance, signal management, and benefit-risk evaluation across clinical development programs. The position involves integrating complex safety information from various sources to inform development strategy, regulatory interactions, and key program decisions throughout the product lifecycle. The Senior Scientist will also provide safety science input to cross-functional teams on patient safety and risk management, and support the implementation of pharmacovigilance processes and continuous improvement initiatives.

Requirements

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.

Nice To Haves

Experience in neurodegenerative diseases, rare diseases, and/or first-in-human clinical development preferred.

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.