Sr. Manager, TMF Operations

Clinical Operations · San Diego, California
Department Clinical Operations
Employment Type Full Time
Minimum Experience Senior Manager/Supervisor

 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, TMF 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.

 

We currently have an excellent opportunity for a talented Sr. Manager, TMF Operations to join our team!  


Position Summary:

Responsible managing Trial Master File (TMF) operations to ensure processes and study TMFs remain inspection ready, in compliance with relevant regulations, ICH-GCP guidelines and Xencor SOPs.


Primary Responsibilities:

  • Ensures the TMFs are maintained and managed in accordance with relevant regulations, ICH-GCP guidelines and Xencor SOPs
  • Acts as the main point-of-contact at Xencor for TMF operations, liaises with internal personnel and external organizations (e.g., CROs) performing TMF activities
  • Provides technical oversight of the Veeva Vault Systems electronic Trial Master File (eTMF) as an eTMF Vault Owner
  • Participates, as needed, with Veeva eTMF system administration on system specification, configuration, migration, UAT, reports/metrics, implementation of system, and provides user support
  • Develops TMF related SOPs, plans, forms, etc., in compliance with applicable regulations
  • Serves as subject matter expert on TMF operations, documentation requirements, and Veeva eTMF
  • Ensures study TMF is maintained with an audit-ready strategy
  • Participates in audits and/or inspections
  • Ensures document quality and compliance through active engagement with clinical study teams, Xencor personnel, and study vendor teams
  • Identifies opportunities for continuous process improvement; recommend solutions, participate in implementation, as required
  • Develops training materials on TMF process, system use, and relevant SOPs
  • Provides training and mentoring, as needed, (e.g., CTAs, CRAs, external users, those new to the company, trial, or eTMF system)
  • Oversees QC and filing of study documents and eTMF metadata specifications
  • Uploads, reviews, and approves eTMF documents, as required
  • Oversees the development and finalization of trial specific TMF plans, and processes
  • Evaluates trial-specific requirements (e.g., required documents, blinding, etc) to ensure appropriate and timely set-up, ongoing maintenance, and archive of the eTMF
  • Oversees, ongoing TMF quality checks and processes (e.g., TMF reviews, metric reviews, etc.) to support inspection readiness; participates as needed
  • Ensures TMF deficiencies and discrepancies are addressed and resolved in a timely manner
  • Develops reports and other tools to support TMF management
  • Adheres to all department and company-wide policies regarding conduct, performance and procedures.
  • Provides oversight and direction to assigned direct and indirect reports, as applicable in accordance with the organization’s policies and procedures.  The responsibilities may include, but are not limited to recruiting, training, communicating job expectations, appraising and managing job performance, delivering feedback and coaching, and providing career development planning and opportunities
  • Performs other duties as required.


Education/Experience/Skills:


Position minimally requires High School/GED completion and a minimum of 8 years relevant experience in clinical trial research focused on clinical trial document collection and TMF management, and at least 5 years’ experience with eTMF system(s) and TMF operational management.  A Bachelor’s degree and a minimum of 4 years’ previously stated experience strongly preferred. Also requires at least 3 years in a supervisory role and prior experience in managing relations with internal, external clients or vendors.  Experience working within a small to midsize biotech or pharmaceutical company, TMF audits/inspections, SOP and process development and Veeva eTMF experience also required.


Position also requires:

  • Strong working knowledge of ICH-GCP practices, and regulatory guidance as it applies to trial documents and TMF.
  • Analytical thinker with excellent organization skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
  • Ability to work independently and collaboratively to arrive decisions and solutions
  • Experience with Drug Information Association (DIA) Trial Master File Reference model, and understanding of records management best practices
  • Thorough understanding of clinical trials, drug development, Phase I through Phase III
  • Computer skills including proficiency in use of Microsoft Outlook, Word, Excel, and PowerPoint (SmartSheet preferred)
  • Ability to establish and maintain effective working relationships with direct reports, coworkers, managers, and vendors
  • Ability to effectively manage others through coaching and supervision, in accordance with company policies and practices.  Ensures employee performance meets the organization’s expectations for conduct, productivity, quality, continuous improvement, and goal accomplishment.


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.

 

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.

 

Thank You

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  • Location
    San Diego, California
  • Department
    Clinical Operations
  • Employment Type
    Full Time
  • Minimum Experience
    Senior Manager/Supervisor