Clinical Science Director
5 days ago
Xencor is a leading biopharmaceutical company dedicated to developing innovative treatments for patients with cancer and other serious diseases. We are seeking a highly skilled Clinical Science Director to join our team in San Diego, CA.
Job Summary:The Clinical Science Director will be responsible for facilitating the successful initiation and completion of our clinical development programs. This includes executing and monitoring medical aspects of selected clinical oncology trials, creating clinical trial documents, and working closely with Clinical Operations to execute trials with high quality and according to timelines.
Key Responsibilities:- Creates 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 clinical trials 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 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 KOLs.
- Leads review of study 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.
- BS degree in life sciences; PhD, RN, PharmD, or MS preferred.
- Minimum of 12 years of directly relevant pharmaceutical industry experience in clinical development and a minimum of 4 years with an oncology focus.
- Experience as a clinical scientist responsible for data review, safety monitoring, protocol development, supporting data analyses, interpretation, and publications.
- Oncology clinical research experience, strong hands-on working knowledge of drug development, and experience working on cross-functional clinical trial teams and liaising with study investigators.
Xencor offers a competitive total rewards package, including 401k match, healthcare coverage, ESPP, and a broad range of other benefits. This position will be eligible for an annual bonus and equity grant.
Xencor is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive work environment that values diversity, equity, and inclusion.
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