Associate Director, Clinical Science; Autoimmune

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. We are advancing our pipeline toward clinical proof‑of‑concept decisions to create high‑impact therapeutics for patients with cancer and other serious diseases. More than 20 XmAb drug candidates are in clinical development, and three have been marketed by partners.

Xencor offers an excellent opportunity for an Associate Director, Clinical Science (Autoimmune) to join our team. This is a hybrid or remote position based out of San Diego or Pasadena, CA.

Responsible for facilitating the successful and timely initiation and completion of the Company’s clinical development programs in Inflammatory Bowel Disease (IBD) and other autoimmune programs by executing and monitoring medical aspects of selected global clinical trials. This role supports the design, execution, monitoring, and interpretation of randomized, placebo‑controlled clinical trials in IBD and studies in healthy volunteers.

• Creates required clinical trial documents including protocols, investigator brochures, DSURs, and IND modules (in concert with Study Medical Directors)
• Works closely with Clinical Operations to execute the clinical trial with high quality and according to timelines
• Performs ongoing review of clinical data, query generation/resolution, and data analysis, including review of draft listings to support data cleaning and interpretation
• Provides scientific expertise to Clinical Operations by responding to questions and clarifying issues arising during study conduct
• Provides internal safety monitoring for clinical trials in collaboration with the Study Medical Director
• Provides medical input for the clinical database build, CRFs, monitoring plan, data management plan, safety monitoring plan, and statistical analysis plan
• Develops and maintains relationships with clinical trial investigators and therapeutic area key opinion leaders
• Leads review of study data (tables, listings, figures, and emerging bioanalytical data) and develops CSRs, clinical presentations, and publications
• Supports other members of Clinical Development and Regulatory Affairs departments as required
• Participates as a standing member of multidisciplinary Project Teams
• Adheres to all department and company-wide policies regarding conduct, performance, and procedures
• Performs other duties as required

Position requires a BS degree in life sciences;
PhD, RN, PharmD, or MS preferred. Minimum 10 years of directly relevant pharmaceutical industry experience in clinical development and minimum 2 years of focused experience in the assigned therapeutic area. Must be a clinical scientist responsible for data review, safety monitoring, protocol development, supporting data analyses, interpretation, and publications, with clinical research experience in IBD on randomized, placebo‑controlled trials. Prior experience with translational medicine/early phase clinical trials, monoclonal antibody biologics/immunotherapy, and relevant tasks throughout the entire study life cycle is preferred.

• Strong initiative, motivation, organization, and hands‑on approach with outstanding attention to detail
• Expertise in analysis and interpretation of emerging clinical data, including use of software packages to analyze data (e.g., pivot tables) and EDC: MS Office Suite, Visio, Graph Pad Prism, Spotfire, Medidata RAVE, Inform, etc.
• Ability to work independently and prioritize multiple tasks and goals to ensure timely, on‑target and within‑budget accomplishments
• Excellent written and oral communication skills and interpersonal skills
• Ability to adjust style and content to suit the audience and purpose
• Self‑starter, highly motivated, and highly organized with outstanding attention to detail
• Ability to demonstrate competencies applicable for the job based on Xencor’s Leadership Competency Model

Occasional travel may be required, including…