This job provides senior clinical leadership for safety strategy and oversight across multiple development programs or a therapeutic area. Leads complex safety assessments, drives cross-functional safety decision-making, and contributes to portfolio-level benefit–risk evaluation. Key Accountabilities / Core Job Responsibilities: • Provides strategic safety leadership across multiple programs or therapeutic area. • Leads safety signal detection (including complex cases), evaluation, and risk assessment and management activities across development programs. • Owns and drives benefit–risk assessments for assigned products and informs program and portfolio decisions. • Oversees preparation and review of aggregate safety reports, regulatory safety submissions, and safety sections of regulatory filings. • Provides medical review and causality assessment of individual case safety reports • Provides senior medical safety leadership in safety governance forums, including Safety Review Committees and Data Monitoring Committees. • Partners with Clinical Development, Regulatory Affairs, and Biostatistics to shape safety monitoring strategies for clinical programs. • Leads development and implementation of risk management strategies, including 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 other safety scientists within the function. • Contributes to safety process improvements, standards, and best practices across the organization. • Participates in regulatory inspections and internal audits. Qualifications/Skills: • 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. Salary Range: $272,000.00 to $336,000.00 . Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. 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 This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.