Sr. Director, Clinical Science (Autoimmune)

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. Director, Clinical Science (Autoimmune), to join our team.

This is a hybrid or remote position. Hybrid would be based out of our San Diego or Pasadena, CA locations.

Summary:

Responsible for facilitating 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 will support the design, execution, monitoring, and interpretation of randomized, placebo-controlled clinical trials in IBD as well as studies in healthy volunteers.

Primary Responsibilities:

• Creates required clinical trial documents including clinical protocols, investigator brochures, DSURs and clinical modules of the IND (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/or by 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 (e.g., tables, listings and 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 multidiscipline Project Teams
• 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 required.

Education/Experience/Skills:

Position requires a BS degree in life sciences; PhD, RN, PharmD or MS preferred and a minimum of 15 years of directly relevant pharmaceutical industry experience in clinical development and a minimum of 4 years’ experience of focus in assigned therapeutic area. Experience as a clinical scientist responsible for data review, safety monitoring, protocol development, supporting data analyses, interpretation and publications also required, as well as 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, from study concept to database lock and CSR is preferred.

Position also requires:

• 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, GraphPad 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/contents to suit the audience/purpose
• Self-starter, highly motived, highly organized and hands on with outstanding attention-to-detail
• Ability to demonstrate competencies applicable for job based on Xencor’s Leadership Competency Model
• Ability to lead cross-functional teams

Occasional travel may be required, including travel between Xencor’s Pasadena and San Diego offices. Work for this position is generally performed at Xencor’s worksite and requires full-time commitment.