Senior Medical Director, Safety Strategy & Risk

Denali Therapeutics; South San Francisco (CA); On-site; USD 272,000 - 336,000; Full time

Benefits offered by this job

401k

Healthcare coverage

ESPP

Job summary

Denali Therapeutics is seeking a senior safety leader to guide medical safety strategy across multiple development programs. You will drive signal detection, risk assessment, and cross-functional decision-making to optimize benefit–risk profiles.

With 10+ years in pharmacovigilance or clinical development, you will oversee regulatory safety submissions, mentor safety staff, and shape global safety monitoring strategies, contributing to audits and inspections.

Qualifications

• MD or MD/PhD with senior safety leadership experience.
• 10+ years in drug safety/pharmacovigilance or clinical development.
• Deep knowledge of global pharmacovigilance regulations and risk management.

Responsibilities

• Provide strategic safety leadership across multiple programs or therapeutic areas.
• Lead safety signal detection, evaluation and risk assessment across development programs.
• Own benefit–risk assessments and inform portfolio decisions.
• Oversee aggregate safety reports, regulatory safety submissions, and safety sections of filings.
• Provide medical review and causality assessment of individual case safety reports.
• Lead safety governance forums including Safety Review Committees and DMCs.
• Partner with Clinical Development, Regulatory Affairs and Biostatistics to shape safety monitoring strategies.
• Develop and implement risk management plans (RMPs) and REMS where applicable.
• Represent Drug Safety in cross-functional program teams and governance discussions.
• Mentor and develop Medical Directors and safety scientists.
• Contribute to safety process improvements and best practices.
• Participate in regulatory inspections and internal audits.

Skills

Drug safety leadership

Pharmacovigilance

Global regulatory knowledge

Cross-functional influence

Clinical credibility

Education

MD or MD/PhD

Job description

Denali Therapeutics is seeking a senior safety leader to guide medical safety strategy across multiple development programs. You will drive signal detection, risk assessment, and cross-functional decision-making to optimize benefit–risk profiles.

With 10+ years in pharmacovigilance or clinical development, you will oversee regulatory safety submissions, mentor safety staff, and shape global safety monitoring strategies, contributing to audits and inspections.