Xencor is an innovative, clinical-stage biopharmaceutical 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 cytokines with improved function, with the goal of improving patient outcomes and quality of life. We have an excellent opportunity for a
Sr. Manager, Supply Chain (Drug Sourcing for Clinical Trials) to join our team.
In this role you will be working remotely with the occasional in office meeting - 1 day/week. We would prefer candidates who are with in a commutable distance to San Diego
Our protein engineering capabilities and the modular nature of our XmAb technology allow us to quickly identify and create new platforms and drug candidates for potential development. We are advancing a deep clinical pipeline of novel drug candidates, including eight bispecific antibodies and two engineered cytokines, and more programs are expected to start clinical testing in 2022. We also leverage our many XmAb technologies by collaborating with leading global biopharmaceutical companies, including Genentech and Janssen Biotech, among others, and including our partnerships, 20 XmAb drug candidates are advancing through clinical development. Three XmAb medicines, to treat patients with a range of serious illnesses, such as aggressive lymphoma, rare blood disorders and COVID-19, are now marketed worldwide by partners.
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.
Responsible for managing procurement and distribution activities in support of Xencor clinical trials.
- Manages sourcing, procurement, and distribution of biopharmaceutical clinical supply, comparators, and combination drugs as required
- Ensures all clinical trials receive timely and adequate supply for patients in support of the company's clinical studies
- Manages distribution activities in support of clinical trials.
- Oversees all logistics issues related to shipments to individual sites and to regional Depots as required
- Manages QP Release function, supporting QA in scheduling and documentation required
- Oversees Depots, providing input as to locations, operations, and logistics in support of clinical trials
- Resolves shipping excursions on a timely basis in collaboration with QA
- Ensures IP is cleared for import/export as required with Regulatory team
- Manages sourcing strategy and tactical activities for comparator and combination drugs in support of Clinical studies
- Partners with CMC, QA, RA, and clinical operations to ensure proper labeling strategy for comparator and combination drugs and provide input and/or samples as needed
- Collaborates with CMC Drug Product and Supply Chain team regarding required CMC budgeting, timelines and/or similar matters to ensure a seamless flow of information and planning for the clinical study to the CMC program level
- Develops effective supply strategies maximizing available inventory by location and shelf life while minimizing waste and potential obsolescence
- Leads risk mitigation through detailed insight of comparator and combination drug supply and demand issues for programs of strategic importance, cost, and/or constrained supply
- Assists in development of clinical supply budgets and revisions as required
- Adheres to all department and company-wide policies regarding conduct, performance, and procedures
- Perform other duties as required
Position requires a Bachelor's degree, preferably in Life Sciences, Business (Economics, Operations Management, Clinical Supply Chain Management, Clinical Trials Coordination) or Engineering; Advanced degree and APICS CPIM, CSCP certifications preferred. Also requires at least 8 years of directly relevant work experience in clinical supply chain management forecasting and planning for clinical studies within Clinical Supply Chain, Clinical Operations, Planning, Manufacturing, Quality, or other Supply Chain disciplines, preferably in the Biotechnology/Pharmaceutical industry. Also requires prior people and project management experience for bulk drug products, IMP, comparators, and/or finished goods.
The company reserves the right to consider internal experience in lieu of the education or experience requirements listed above.
Position also requires:
- Strong knowledge of supply chain processes including internal and external alignment (sourcing, manufacturing, quality, analytics, regulatory, finance, clinical operations)
- Working knowledge of cGMP's as related to large molecule biopharmaceutical activities, familiar with US, EU, and global regulations applicable to investigational drugs and GCP regulations applicable to investigational product and supply
- Flexibility and willingness to adapt to changing business environment influences by developing and adopting new strategies and tactics. Ability to think strategically and translate into actionable plans.
- Strong ability to collaborate and build strategic and tactical relationships with internal (clinical operations, quality, regulatory, etc.) as well as external (CDMO, CPO, storage sites, etc.) stakeholders
- Strong budget management and financial analysis skills
- Ability to lead process improvement activities, delivering business processes and/or technical solutions satisfying multiple sets of stakeholders
- Strong planning, organization, and time-management skills to juggle needs of multiple teams and projects simultaneously
- Ability to demonstrate good judgment in determining objectives and approaches to assignments
- Excellent verbal/written communication and presentation skills, including ability to simplify what is complex and focus audience on key messages
- Strong computer (Excel, Word, PowerPoint, Visio) skills. Experience with Clinical Demand Planning and Inventory management systems.
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 when working in the office environment 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. Additional travel (domestic and/or international) for scientific conferences and/or other meetings with collaborators is possible. Otherwise, work for this position is generally performed at Xencor's worksite and requires full-time commitment.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, including any boosters recommended by the CDC. New employees will be required to provide proof of their fully COVID-19 vaccinated status as of their start date unless an exemption or accommodation is approved.
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 .
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.