Senior Scientist, Safety Science

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.

Supports the implementation of pharmacovigilance processes and contributes to continuous improvement initiatives.

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.

Pay

$155,000.00 to $202,000.00

Benefits

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.