Xencor Inc. is an innovative biotechnology company located in the Los Angeles area (near Pasadena) and in San Diego. We recently completed a successful IPO and have an excellent opportunity for a Clinical Trial Manager/Sr CTM to join our team. We use our pioneering XmAb® technology to develop better biotherapeutics – antibodies that target new biological mechanisms and are more potent, safer and longer lasting – to improve patient outcomes and quality of life. In addition to generating a pipeline of novel drug candidates, with eight in clinical testing by Xencor or our partners, our XmAb® technology has been validated through our collaborative agreements with leading biopharmaceutical companies including Amgen, Novo Nordisk, Morphosys, Merck, CSL, Janssen(J&J), Alexion and Boehringer Ingelheim.
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 successful candidate, to be based in the San Diego office will be an experienced, self-motivated CTM/Sr CTM to lead the day-to-day Clinical Operations functional activities associated with the execution of ongoing clinical trials outsourced to third party Vendors and CROs.
Job Duties include:
Manages and leads the day-to-day clinical trial activities related to the development and execution of cross-functional and third-party vendor activities and deliverables, including but not limited to, development and/or review of clinical data management conduct (e.g. eCRFs, CRF guidelines, edit check specifications, database build, query resolution and database cleaning), relevant study plans (e.g. monitoring, study operations, quality, communications, etc.), protocol review for operational feasibility and consistency, tracking site selection and activation and patient recruitment and tracking to project timelines
Clinical operations leader and main point of contact with counterpart at outside vendor, CRO and/or trial sites; daily review and identification of potential issues or problems and communicates/escalates to CTL/Project Team
Develops, maintains and promotes, effective and collaborative working relationships with and among internal team members and external vendors and 3rd party personnel to develop team esprit de corps
Participates in Clinical Operations initiatives and programs as assigned, including identifying areas of best practice and recommends process improvements, development of SOPs and department level training and cross project initiatives
Prepare and maintain Trial Master Files (TMF) for multiple studies, ensuring tracking of ICH-GCP and/or FDA CRF21 essential study documents. Inform the CTL/Project Team on any outstanding document/s
Develops knowledge of sample collection and analysis process at the study level and may perform reconciliation and/or tracking of sample manifests
Lead reviews of key data to identify trends, discrepancies, errors etc. to ensure ongoing quality of conduct in accordance with the protocol and vendor contracts, including on-going review of emerging data for tables, listings and figures
Performs in-house review of site monitoring reports and tracking to ensure appropriate monitoring of trial conduct and satisfactory resolution of outstanding issues
Develop and maintain tracking spreadsheets with study level information to enable accurate and efficient supply of clinical drug product (IMP) and clinical supplies to Sites, Vendors and CROs
Support financial oversight of clinical studies through invoice tracking and reconciliation for potential change orders
Tracking of patient and recruitment status using applicable spreadsheets and web portal tools
Assist in the critical development and review of key study documents (eg, Protocol, ICF, study plans, eCRF etc.)
Bachelor’s or graduate degree in a field of science or nursing, preferably biology, chemistry, or pharmacy.
For CTM, at least 5 years clinical operations experience as a clinical research associate. For Sr. CTM, at least 8 years clinical operations experience, with at least 5 years as a clinical research associate
Expert knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials
Expert time management and organizational skills
Excellent attention to detail and accuracy in work, with a strong work ethic, willing to put in the time and effort to complete critical tasks on time with quality
Ability to establish and maintain effective working relationships with coworkers, managers and clients
Computer skills including proficiency in use of Microsoft Outlook, Word, PowerPoint and Microsoft Project
Must think critically and creatively and be able to work independently to determine appropriate actions to resolve complex problems
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.
For further information about Xencor, please visit our website at www.xencor.com EOE