Senior Medical Director, Safety Strategy & Risk

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

Benefits offered by this job

401k

Healthcare

ESPP

Benefits

Job summary

Denali Therapeutics Inc in South San Francisco seeks a senior clinical safety leader to drive safety strategy across multiple programs. You will lead risk management, signal detection, and regulatory submissions while mentoring safety scientists.

The role requires MD/PhD with 10+ years in drug safety or clinical development, and the ability to influence cross-functional decisions in a fast-paced biotech setting. Competitive compensation accompanies a robust benefits package.

Qualifications

• MD or MD/PhD required.
• 10+ years of relevant experience in drug safety, pharmacovigilance, or clinical development with progression to program or multi-program safety leadership.
• Deep understanding of global pharmacovigilance regulations, signal detection methodologies, and safety risk management.
• Demonstrated ability to influence cross-functional decisions and lead complex safety discussions.
• Recognized clinical and scientific credibility.

Responsibilities

• Provides strategic safety leadership across multiple programs or therapeutic area.
• Leads safety signal detection, evaluation, and risk assessment across development programs.
• Owns benefit–risk assessments and informs program and portfolio decisions.
• Oversees preparation and review of aggregate safety reports and regulatory submissions.
• Provides medical review and causality assessment of individual case safety reports.
• Leads safety governance forums, including Safety Review Committees and Data Monitoring Committees.
• Partners with Clinical Development, Regulatory Affairs, and Biostatistics to shape safety monitoring strategies.
• Leads development and implementation of risk management plans (RMPs) and REMS where applicable.
• Represents Drug Safety in cross-functional program teams and governance discussions.
• Mentors and develops Medical Directors and safety scientists.
• Contributes to safety process improvements and best practices.
• Participates in regulatory inspections and internal audits.

Skills

MD/PhD

Drug safety

Cross-functional influence

Clinical development

Job description

Denali Therapeutics Inc in South San Francisco seeks a senior clinical safety leader to drive safety strategy across multiple programs. You will lead risk management, signal detection, and regulatory submissions while mentoring safety scientists.

The role requires MD/PhD with 10+ years in drug safety or clinical development, and the ability to influence cross-functional decisions in a fast-paced biotech setting. Competitive compensation accompanies a robust benefits package.