Associate Director, Safety Ops

Neurodegenerative diseases are one of the largest medical challenges of our time. 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.

We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.

Leads the execution and continuous improvement of global pharmacovigilance operations to ensure compliant, efficient, and high-quality safety data management across clinical and post-marketing programs. Drives cross-functional coordination and vendor oversight to support timely adverse event reporting, inspection readiness, and regulatory compliance. Contributes to the enhancement of pharmacovigilance processes and systems to support program advancement and global expansion.

Key Accountabilities / Core Job Responsibilities

• Oversee global pharmacovigilance operations for assigned clinical programs

• Ensure compliant safety case intake, processing, reporting, and reconciliation across all sources (including clinical studies and post-marketing sources)

• Oversee safety case management activities to ensure adherence to global regulatory requirements, company procedures, and reporting timelines

• Manage pharmacovigilance vendors and external partners, ensuring performance, compliance, and alignment with contractual and operational expectations

• Lead the development and oversight of safety data exchange agreements (SDEA) / PV Agreements (PVA) with license partners and/or other parties

• Drive continuous improvement of pharmacovigilance processes, systems, and workflows to enhance efficiency and quality

• Lead the planning and operational delivery of aggregate safety reports (e.g., DSUR, PBRER, PADER)

• Partner cross-functionally with Clinical, Regulatory, Safety Science, and other stakeholders to ensure effective adverse event handling and communication

• Monitor pharmacovigilance compliance metrics (KPIs/KQIs), identify trends, and implement corrective and preventive actions as needed

• Support regulatory inspections, audits, and inspection readiness activities, including documentation and response preparation

• Contribute to the development and maintenance of pharmacovigilance procedures and training to ensure organizational awareness and compliance

• Support safety-related inputs into clinical and regulatory documents (e.g., protocols, Safety Management Plans, MA submissions)

• Support the implementation of safety procedures related to the company international market expansion efforts

Qualifications / Skills

• Typically requires a Bachelor’s degree and 12+ years of relevant experience, or an equivalent combination of education and experience, with strong focus on pharmacovigilance safety operations in a global environment

• Demonstrated expertise in global pharmacovigilance regulations and guidelines (e.g., FDA, EMA, ICH)

• Experience managing vendors and external partners supporting pharmacovigilance activities

• Proven ability to independently lead complex, cross-functional initiatives and manage multiple priorities

• Experience supporting regulatory inspections and audits within a pharmacovigilance system

• Strong communication, organizational, and problem-solving skills with ability to operate effectively in a fast-paced, matrixed environment

• Experience in both pre-approval and post-marketing pharmacovigilance activities

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do 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.