Clinical Dev - Director, Clinical Science
Responsible for successful and timely initiation and completion of the Company’s clinical development programs by executing and monitoring medical aspects of selected clinical oncology trials.
- 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 and pharmacovigilance
- Provides clinical 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 KOL’s
- 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.
Position requires a BS degree in life sciences; PhD, BSN, PharmD or MS preferred and a minimum of 8 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 also required. Also requires 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. 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:
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.
Expected Base Salary Range: $196,000.00 - $226,000.00
The actual salary will be based on the selected candidate’s qualifications, including skills, competencies, education and experience. Xencor offers a competitive total rewards package including 401k match, healthcare coverage, ESPP and a broad range of other benefits. In addition, this position will be eligible for an annual bonus and equity grant. For more information, please see https://xencor.com/careers/.
Xencor requires all employees to be fully vaccinated against COVID-19 as a condition of employment. Being fully vaccinated means that at least two weeks have passed since an individual’s final dose of an authorized COVID-19 vaccine regimen. New employees will be required to provide proof of their COVID-19 vaccination status as of their start date unless an exemption or accommodation is approved.
- Job Family Director Jobs
- Pay Type Salary
- Travel Required Yes
- Travel % 10
- Required Education Bachelor’s Degree
- Xencor San Diego Office, 12770 El Camino Real, San Diego, California, United States of America