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 Manager/Sr Manager Clinical Contracts and Outsourcing to join our Clinical Development 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 Novartis, Amgen, 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 will be an experienced, self-motivated Manager/Sr Manager Clinical Contracts and Outsourcing to support the day-to-day activities of the Clinical Department.
Job Duties include:
• Responsible for ensuring quality oversight of suppliers; maximize the value obtained from partnerships with external providers at study, program or supplier level
• Responsible for the coordination and management of clinical outsourcing needs in support of current and planned clinical trials, including vendor identification and selection, Request for Proposal (RFP) and negotiating contracts, managing outsourcing budgets, vendor performance metrics, and vendor oversight/governance.
• Generates Requests for Information (RFI) and Requests for Proposals and applies standard budget grids to evaluate Vendor data
• Coordinates bid defenses and proposal review meetings and provides analysis to project teams and Sr. Director Clinical Operations
• Contract lifecycle management: manages clinical contracts and change orders, including active negotiation of scope of work, payment terms and budgets
• Develops tracking tools to collect and analyze projects/contracts plan vs actual performance against contract milestones
• Prepared monthly management reports on financial performance to explain/communicate key variance drivers and insights
• Provided key financial support and analysis on ad-hoc basis to help drive and improve business performance as needed
• Assists clinical teams and finance with month-end and budget/forecasting needs, such as accruals, project budgets and change orders
• Partners with suppliers and internal stakeholders to identify, manage, escalate and resolve issues related to supplier performance
• Measures supplier performance utilizing Scorecard/Metric activities; and communicating feedback to the supplier, encourage adaptation on best practices across supplier types and development of continuous process improvements/ maintenance
• This role must be able to interact on a day-to-day basis with the clinical teams, corporate finance and project management to provide effective oversight of clinical budgets
• Demonstrates a basic understanding of the regulatory implications of contracts as related to Clinical Research and Finance
• Identify current trends in outsourcing practices in the industry
• Identifies, develops and implements outsourcing processes and procedures
• Leads and contributes to complex functional or company initiatives and special projects as identified by clinical management or business need
• May directly supervise staff as they are hired into the organization
• Excellent organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
• Works on unique issues where analysis of situations or data requires an evaluation of intangibles
• Ensures budgets and schedules meet department and corporate requirements
• Understanding of clinical trials, drug development, Phase I through Phase III
• Finance, contracts negotiations, budget negotiations, vendor management
• Computer skills including proficiency in use of Microsoft Outlook, Word, Excel and PowerPoint
• Experience with SmartSheet, Grants Manager, PICAS and/or other industry cost and planning tools (strongly preferred)
• BS/BA degree in Life Science, Finance, Business Strategy related discipline and six years of related experience; or, MS/MA degree in Life Science, Finance, Business Strategy related discipline and five years of related experience; or, equivalent combination of education and experience.
• Typically requires a minimum of 5-8 years of Life Science, Finance, Business Strategy related experience and/or combination of experience and education/training
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.