Xencor Inc. is an innovative biotechnology company located in the Los Angeles area (near Pasadena) and in San Diego. We use our pioneering XmAb® technology to develop better biotherapeutics/antibodies that target new biological mechanisms and have the potential to be more potent, safer and longer lasting with the goal of improving patient outcomes and quality of life. Currently, we have five programs in clinical development (four in oncology) and plan to start clinical development of two more oncology programs within the next year. In addition to generating an internal pipeline of novel drug candidates, our XmAb® technology has enabled multiple collaborations with leading biopharmaceutical companies including Novartis, Amgen, MorphoSys, Merck, CSL, Janssen(J&J), Alexion and Boehringer Ingelheim.
We have an exciting opportunity for a Director/Senior Director Clinical Development (Oncology) to join our team. 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.
The Director/Senior Director Clinical Development (Oncology) will play an integral role in facilitating successful and timely initiation and completion of the Company’s clinical development programs and serve as Medical Director for selected company oncology clinical studies. The Director/Senior Director Clinical Development (Oncology) will work directly with members of Xencor Clinical Operations, Clinical Project Managers, Data Management and Biostatistics, Clinical Research Organizations (CROs) and Clinical Investigators to plan, execute and monitor medical aspects of selected clinical oncology trials. The successful candidate will operate in a highly detailed and organized fashion with the goal of efficiently driving each program through the clinical development process. The Director/Senior Director Clinical Development (Oncology) will have a strong familiarity with good clinical practices, be a highly motivated, hands on, detail-oriented individual with the ability to formulate, develop and execute clinical trials and be able to operate in a highly dynamic environment.
The Director/Senior Director Clinical Development (Oncology) job duties may include:
• Create required clinical trial documents including clinical protocols, investigator brochures, DSURs and clinical modules of the IND
• Work closely with Clinical Operations to execute the clinical trial with high quality and according to timelines
• Perform ongoing review of clinical data, query generation/resolution and data analysis, including review of draft listings to support data cleaning and interpretation
• Provide medical expertise to Clinical Operations by responding to questions or clarifying issues arising during study conduct
• Provide internal safety monitoring for clinical trials
• Provide medical input for the clinical database build, CRFs, monitoring plan, data management plan, safety monitoring plan and statistical analysis plan
• Develop and maintain relationships with clinical trial investigators and therapeutic area key opinion leaders as needed
• Lead review of study data (e.g. Tables, Listings and Figures and emerging bioanalytical data) and development of CSRs, clinical presentations and publications
• Support other members of Clinical Development and Regulatory Affairs departments as may be required
• Participate as a standing member of multidiscipline Project Teams
• Interact with external investigators and collaborators
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
• MD required with oncology clinical research experience and strong hands-on working knowledge of drug development. Board certified/eligible in Hematology/Oncology a strong plus
• 5+ years’ (3+ years in oncology) directly relevant pharmaceutical industry experience in clinical development with previous experience including: 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
• Prior experience with relevant tasks throughout the entire study life cycle, from study concept to database lock and CSR, is a plus.
• Prior experience with monoclonal antibody biologics/immunotherapy clinical development is a plus
• Experience in translational medicine/early phase clinical trials is a plus
• Self-starter, highly motived, highly organized and hands on with outstanding attention-to-detail
• Able to work independently and prioritize multiple tasks and goals to ensure the timely, on-target and within-budget accomplishment
• Excellent written and oral communication skills and interpersonal skills
• Experience 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.
The physical 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 association 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. Work is performed in an office environment.
We strive to create an environment that will challenge, motivate, and reward our employees for meeting the changing demands of creating breakthrough therapeutics. Xencor has a highly collaborative structure that integrates co-workers with different skill sets into teams for product and technology development. With an emphasis on attaining the best and most highly qualified candidates in their respective fields, we offer a competitive salary & benefits package.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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