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About the Role

Denali Therapeutics is a biotechnology company focused on developing breakthrough therapies for neurodegenerative diseases. This role provides scientific leadership for safety surveillance, signal management, and benefit-risk evaluation, integrating complex safety information to inform development strategy and regulatory interactions throughout the product lifecycle.

Responsibilities

• Conduct safety surveillance, signal detection, signal evaluation, and benefit-risk assessment activities for assigned development programs.
• Integrate data from clinical studies, post-marketing experience, scientific literature, and other relevant sources to support product safety profile characterization.
• Contribute to product safety strategy in collaboration with cross-functional stakeholders.
• Support safety contributions to regulatory submissions and health authority interactions.
• 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 various teams, providing safety assessments and recommendations.
• Present safety findings and recommendations to committees and stakeholders.
• Provide safety science input on clinical development documents to support patient safety oversight.
• Contribute to the development and improvement of pharmacovigilance processes, standards, methodologies, and tools.
• Share safety science knowledge and provide guidance on signal evaluation methodologies and regulatory expectations.
• Represent Drug Safety in interactions with external partners, investigators, contract research organizations, and regulatory agencies.

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

Skills

• Safety surveillance
• Signal management
• Benefit-risk evaluation
• Pharmacovigilance
• Regulatory submissions
• Risk management

Location

• Remote

Work Type

• Full-time

Experience Level

• 10+ years of related experience with a Bachelor's degree
• 8+ years with a Master's degree
• 3+ years with a PhD

Education Level

• BSN
• MSN
• RN
• NP
• PA
• PharmD
• MD
• Equivalent clinical or scientific degree

Salary/Compensations

• $155,000.00 to $202,000.00

Benefits

• 401k
• Healthcare coverage
• ESPP

About the Company

• 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.
• Life at Denali is a living reflection of our values: trust, unity, grit and growth.
• Our culture thrives on shared purpose and relentless pursuit.

Equal Opportunity

• Denali is proud to be an equal opportunity employer and does 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.