INTRODUCTION:

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 www.xencor.com. We have an excellent opportunity for a Sr. Medical Director, Drug Safety & Pharmacovigilance, to join our team.
This position can be fully remote or based out of our San Diego office. This position requires travel to the San Diego office including up to quarterly visits.

SUMMARY:

Responsible for managing drug safety and PV related activities involving Xencor products.

EDUCATION/EXPERIENCE/SKILLS:

Position requires an Medical Doctor (MD) or an internationally recognized equivalent, and a minimum of 8 years’ experience in drug safety/pharmacovigilance or as a medical monitor and at least 6 years of clinical experience. Also requires at least 5 years managing medical case review and signal detection. Experience in oncology and/or autoimmune drug development is preferred.

• Performs signal detection activities to ensure signal identification and evaluation, including individual and aggregate data analyses, interpretation of safety signals and trends, and documentation and communication of safety assessments for all investigational products in compliance with global pharmacovigilance and regulatory requirements.
• Provides medical and strategic input for adverse event monitoring, coding, and signal detection to ensure that global PV regulatory requirements for case reporting and management are met.
• Performs medical review of individual case safety reports (ICSRs), including confirmation of triage and assessments, review of narratives, ensures accurate coding and composes Company Comments. Contributes to the creation of analysis of similar events
• Works collaboratively within the Drug Safety and Pharmacovigilance department, across departments, and with partner companies to achieve PV and company goals.
• Focuses on tactical execution while providing direction on process improvements and contributing to the strategic buildout of the department
• Participates in safety activities for Xencor investigational products, including development and implementation of relevant policies and procedures
• Collaborates with partners on safety monitoring and signal detection and risk management activities.
• When relevant, participates in establishing and maintaining Safety Data Exchange Agreements
• Collaborates, reviews and contributes to relevant sections of clinical and regulatory documents, including protocols, informed consent forms, study reports, integrated summaries of safety, expedited safety reports, DSURs, marketing applications and other regulatory submission documents on assigned projects
• Provides direction and monitors contracted vendors in the collection, coding, processing and reconciliation activities involving safety information in clinical trial settings and, when relevant, in the post marketing setting.
• Leads the development and finalization of periodic safety data reports to meet reporting obligations (e.g., DSURs/ IND Annual Reports and/or PADERs/ PSURs/PBRERs)
• Supports the development, review and maintenance of appropriate safety sections of key product documents including: IBs (including RSI determination), study protocols, ICFs, CSRs, CCDS.
• Constructs and summarizes scientific literature relevant to Drug Safety on assigned projects, which includes literature reviews for safety signals
• Participates in inspection readiness activities and preparation as needed
• Stays current with international pharmacovigilance requirements and guidelines (focus on FDA and EMA)
• Functions as a safety subject matter expert (SME) for cross-functional departments (e.g., Regulatory, Quality Assurance, Clinical) and vendors to ensure appropriate and timely handling of safety information/issues.
• Safety support provided with knowledge of new and updated regulations/ guidelines which impact Drug Safety & Pharmacovigilance.
• Participates as a SME during internal audits and assist the Drug Safety/PV team during Agency inspection activities, as required.
• 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
• Provides strategic leadership and direction to the pharmacovigilance team, ensuring the effective and compliant operation of safety systems.
• 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
• Collaborates with cross-functional teams and communicate safety findings and recommendations to senior management.
• Performs other duties as required.