Associate Director, Clinical Science (Autoimmune)

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
• 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
• Performs other duties as required

Education/Experience/Skills

• BS degree in life sciences; PhD, RN, PharmD or MS preferred and a minimum of 10 years of directly relevant pharmaceutical industry experience in clinical development and a minimum of 2 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
• 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
• To demonstrate competencies applicable for job based on Xencor’s Leadership Competency Model