Director, Drug Safety & Pharmacovigilance

Director, Drug Safety & Pharmacovigilance

Xencor, Inc., 12770 El Camino Real, San Diego, California, United States of America

Posted Saturday, June 27, 2026 at 4:00 AM

Xencor is a public, clinical‑stage biopharmaceutical company located in the Los Angeles area (Pasadena) and in San Diego. Our focus is developing high‑potential XmAb® bispecific T‑cell engagers and additional engineered drug candidates that leverage our differentiated technology platforms, and we are advancing our pipeline toward clinical proof‑of‑concept decisions. Our goal is to create high‑impact therapeutics for patients with cancer and other serious diseases.

More than 20 XmAb drug candidates engineered with our technology are in clinical development, and three XmAb medicines have been marketed by partners. For more information, please visit  We have an excellent opportunity for a Director, Drug Safety & Pharmacovigilance, to join our team.

This position will be based in San Diego, CA. and have 2 days a week hybrid on‑site. Potentially for fully remote if not local to San Diego.

Responsible for all aspects of safety related to Drug Safety & Pharmacovigilance (PV) processes and the analytical assessment of safety data for assigned product(s).

• Provides day‑to‑day oversight of safety monitoring activities and processes for assigned product(s)
• Works collaboratively with the Medical Monitor/Clinical Scientist on ICARS, aggregate data review/signaling, and core risk language for assigned product(s)
• Provides clinical review of vendor’s narratives for quality and completeness and ensures timely submission of expedited reports. Contributes to the creation of analysis of similar events
• Facilitates and leads cross‑functional safety data review and signaling meetings; includes setting agenda, coordinating materials, data presentation, and documentation
• Reviews and provides safety functional input for development of protocols, IBs, ICFs, CSRs and other relevant study documents
• Acts as lead author for aggregate safety reports (e.g., DSURs)
• Leads efforts related to ad hoc and routine signal evaluation
• Provides Drug Safety/PV subject matter expertise on cross‑functional platforms and teams throughout the company
• Provides end to end Drug Safety/PV support for assigned products including study start up activities, vendor plans, signal detection plans, SAE review, aggregate data review, signaling, aggregate authoring including DSURs, annual core product document updates (IB, ICF), and CSR authoring as well as informed consent forms, integrated summaries of safety, marketing applications and other regulatory submission documents on assigned products
• Collaborates with partners on safety monitoring, signal detection and risk management activities
• Participates in establishing and maintaining Safety Data Exchange Agreements/Pharmacovigilance Agreements
• Ensures adherence to GCP/ICH and SOP standards
• Participates in inspection readiness activities and preparation
• Ensures that the above tasks are performed in the most efficient manner possible, commensurate with quality, accuracy, and timeliness and in accordance with current global regulatory requirements
• Ensures that all activities/reviews are compliant with the latest safety standards and regulations
• Adheres to all department and company‑wide policies regarding conduct, performance and procedures
• Provides oversight and direction to direct and indirect reports, as applicable, in accordance with the organization’s policies and procedures. The responsibilities may include, but are not limited to recruiting, training, communicating job expectations, appraising and managing job performance, delivering feedback and coaching, and providing career development planning and opportunities
• Performs other duties as assigned

Required

• Advanced nursing degree or PharmD
• At least 8 years drug safety experience
• At least 5 years managing medical case review and signal detection
• At least 4 years of clinical experience

Preferred

• MD
• Experience in a critical care setting
• Experience in oncology and/or autoimmune drug development

• Solid…