Manager, Clinical Operations
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 an Manager, Clinical Operations to join our team.
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.
Guides and assists the clinical operating activities for the Clinical Operations team, providing leadership and management of operational and administrative activities.
Job Duties Include:
- Communicates clinical study status to study teams
- Implements and maintains study status tracking tools and reports to communicate project status updates
- Supports the clinical study teams in project planning, including timelines, and resource management
- Supports the clinical study teams, facilitates sub-team meetings, and organizes ad hoc working groups as needed to move clinical activities forward
- Provides support to team members to objectively assess and resolve project issues by identifying root causes as opportunities to improve project effectiveness
- Supports and proactively works with the clinical study teams to ensure effective project plans are in place in accordance with applicable company standard operational procedures (SOPs), ICH/GCP guidelines, and regulatory requirements
- Ensures potential operations risks/issues are escalated to the attention of the VP of Clinical Operations, when appropriate
- Coaches team members to be proactive in resolving issues
- Identify areas of best practice and recommending process improvements, development of SOPs, Wls, department level training and clinical study metrics
- Adheres to all department and company-wide policies regarding conduct, performance and procedures
- Performs other duties as required.
Position requires a BA/BS in scientific discipline with a minimum of 6 years of clinical trials research experience and/or clinical project management in a pharmaceutical/biotechnology company or CRO. Requires experience providing oversight of clinical research vendors (CROs, central imaging vendors, IXRS).
Experience in Oncology and/or Autoimmune therapeutic areas is preferred. Experience working in a small company in the biotech or pharmaceutical industry, prior people management experience and working with SmartSheet also preferred.
The company reserves the right to consider internal experience in lieu of the education or experience requirements listed above.
Position also requires:
- Technical expertise in and understanding of cross-function clinical trials processes from study start-up through study closure (e.g., data management, safety, biostatistics, medical writing)
- Understanding of clinical development cost drivers
- Working knowledge of ICH GCP as relates to clinical trial management
- Basic understanding of financial planning and managing clinical program budgets
- Strong working knowledge of project management principles
- Excellent attention to detail and accuracy in work with proven ability to work independently with a high level of integrity
- Strong sense of urgency to deliver/surpass study conduct targets
- Ability to support multiple project teams simultaneously
- Ability to accommodate shifting priorities, demands and timelines
- Ability to determine personal work plan, schedule tasks and activities accordingly
- Ability to elicit cooperation from a wide variety of sources and to be persuasive, encouraging and motivating
- Ability to establish and maintain effective working relationships with coworkers, assigned staff, and senior management
- Basic knowledge and skill with Microsoft Word, Microsoft Excel and other and tracking tools.
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.
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 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.