Director, Clinical Science (Clinical Scientist)
Xencor is an innovative, clinical-stage biotechnology company located in the Los Angeles area (near Pasadena) and in San Diego. We use our pioneering XmAb® technology to discover and develop better biotherapeutics – antibodies and other proteins with improved function – with the goal of improving patient outcomes and quality of life, and we have an excellent opportunity for an experienced Director of Clinical Science.
Our protein engineering capabilities and the modular nature of our technology allow us to quickly identify and create new platforms and drug candidates for potential development. We are developing a broad portfolio enabled by the rapid expansion of our bispecific technologies, and nine XmAb bispecific antibodies and cytokines are in clinical testing. We also leverage our many XmAb technologies by engaging in multiple collaborations with leading global biopharmaceutical companies, including Novartis, Amgen and Genentech, among others. Including our partners, over a dozen XmAb drug candidates are advancing through clinical development, and the first antibody that incorporates an XmAb technology has been approved for commercial marketing worldwide.
Our employees are the most important factor in our success, and we have assembled a highly talented group from diverse backgrounds and disciplines to execute our business plan and shape our future. Xencor employees’ value new ideas and flexibility and demand from each other scientific rigor, a passion for innovation, and a willingness to take risks.
We currently have an excellent opportunity for a talented Director, Clinical Science to join our team!
Successful candidate will play an integral role in facilitating successful and timely initiation and completion of the Company’s clinical development programs, by collaborating with other internal and external stakeholders to plan, execute and monitor medical aspects of selected clinical oncology trials
Job Duties Include:
- 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 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
- Performs other duties as required.
- BS degree in life sciences; PhD, RN, PharmD or MS preferred
- Minimum of 12 years of directly relevant pharmaceutical industry experience in clinical development with previous experience as a clinical scientist responsible for data review, safety monitoring, protocol development, supporting data analyses, interpretation and publications, experience working on cross functional clinical trial teams and liaising with study investigators.
- Minimum 4 years’ experience with an oncology focus.
- Oncology clinical research experience and strong, hands-on working knowledge of drug development
- Experience required 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.
- 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 a plus.
Physical, Mental and Environment Demands:
The physical, mental and working environment demands described are representative of those that must be met by an employee to successfully perform the primary functions of this position.
The physical demands of the office are normally associated with extended amounts of time sitting and using office equipment, including a computer, keyboard and mouse, which can cause muscle strain. While performing the duties of this job, the employee is frequently required to stand, walk and sit. Periodic light lifting of supplies and materials may apply.
Specific mental demands for the position are listed above under requirements. In addition, mental demands for this position include:
- Ability to multitask without loss of efficiency or accuracy, including the ability to perform multiple duties from multiple sources.
- Ability to work and sustain attention with distractions and/or interruptions.
- Ability to interact appropriately with a variety of individuals including vendors, customers and clients.
- Ability to maintain regular attendance and be punctual.
- Ability to understand, remember and follow verbal and written instructions.
Occasional travel may be required, including travel between Xencor’s Monrovia and San Diego offices. Work for this position is generally performed at Xencor’s worksite and requires full-time commitment.
Americans with Disabilities Act (ADA) Statement
The Company will provide reasonable accommodations (such as a qualified sign language interpreter or other personal assistance) with the application process upon your request as required to comply with applicable laws. If you have a disability and require assistance in this application process, please contact HR@xencor.com.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.
Equal Employment Opportunity (EEO) Statement
The Company is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender or gender identity, national origin, disability status, protected veteran status or any other characteristic protected by state or federal law.
Xencor does not accept profiles or resumes from recruiting vendors without a binding written agreement. Any unsolicited submission of services and or resumes in no way creates an obligation or duty by Xencor, implied or otherwise.