Xencor
Associate Director, TMF Operations
Xencor, San Diego, California, United States, 92189
Xencor is a public, clinical-stage biopharmaceutical company located in the Los Angeles area (Pasadena) and in San Diego. Our focus is developing high-potential XmAb bispecific T-cell engagers and additional engineered drug candidates that leverage our differentiated technology platforms, and we are advancing our pipeline toward clinical proof-of-concept decisions. Our goal is to create high-impact therapeutics for patients with cancer and other serious diseases. More than 20 XmAb drug candidates engineered with our technology are in clinical development, and three XmAb medicines have been marketed by partners. For more information, please visit
www.xencor.com . We have an excellent opportunity for an Associate Director, TMF Operations to join our team.
This position preferably will be hybrid 2 days a week on-site in our San Diego, CA location. Remote possible.
Summary:
Responsible for leading Trial Master File (TMF) operations and personnel to ensure Xencor processes and study TMFs remain inspection ready, in compliance with relevant regulations, ICH-GCP guidelines and SOPs.
Job Duties:
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 cross-functional 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; recommends solutions, participates 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 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 requires Bachelor’s degree and a minimum of 10 years relevant experience in clinical trial research focused on clinical trial document collection and TMF management, and at least 8 years’ experience with eTMF system(s) and TMF operational management. At least 2 years of prior people management experience and managing relations with internal, external clients or vendors required. Experience working within a small to midsize biotech or pharmaceutical company, Drug Information Association (DIA) Trial Master File Reference model, TMF audits/inspections, SOP and process development and Veeva eTMF experience also required.
The company reserves the right to consider internal experience in lieu of the education or experience requirements listed above.
Position also requires:
Strong working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.Excellent time management and organizational skills.Excellent attention to detail and accuracy in work.Ability to complete critical tasks on time with quality.Ability to establish and maintain effective working relationships with coworkers, managers and vendors.Computer skills including proficiency in use of Microsoft Outlook, Word, PowerPoint and Microsoft Project.Ability to think critically and creatively and be able to work independently to determine appropriate actions to resolve complex problems.Ability to demonstrate competencies applicable for job based on Xencor’s Leadership Competency Model.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.Occasional travel may be required, including travel between Xencor’s Pasadena and San Diego offices. Work for this position is generally performed at Xencor’s worksite and requires full-time commitment.
Expected Base Salary Range:
$155,000 to $180,000. The actual salary will be based on the selected candidate’s qualifications, including skills, competencies, education and experience. Xencor offers a competitive total rewards package including 401k match, healthcare coverage, ESPP and a broad range of other benefits. In addition, this position will be eligible for an annual bonus and equity grant. For more information, please see
https://xencor.com/careers/ .
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. New employees will be required to provide proof of their COVID-19 vaccination 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 .
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.
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www.xencor.com . We have an excellent opportunity for an Associate Director, TMF Operations to join our team.
This position preferably will be hybrid 2 days a week on-site in our San Diego, CA location. Remote possible.
Summary:
Responsible for leading Trial Master File (TMF) operations and personnel to ensure Xencor processes and study TMFs remain inspection ready, in compliance with relevant regulations, ICH-GCP guidelines and SOPs.
Job Duties:
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 cross-functional 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; recommends solutions, participates 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 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 requires Bachelor’s degree and a minimum of 10 years relevant experience in clinical trial research focused on clinical trial document collection and TMF management, and at least 8 years’ experience with eTMF system(s) and TMF operational management. At least 2 years of prior people management experience and managing relations with internal, external clients or vendors required. Experience working within a small to midsize biotech or pharmaceutical company, Drug Information Association (DIA) Trial Master File Reference model, TMF audits/inspections, SOP and process development and Veeva eTMF experience also required.
The company reserves the right to consider internal experience in lieu of the education or experience requirements listed above.
Position also requires:
Strong working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.Excellent time management and organizational skills.Excellent attention to detail and accuracy in work.Ability to complete critical tasks on time with quality.Ability to establish and maintain effective working relationships with coworkers, managers and vendors.Computer skills including proficiency in use of Microsoft Outlook, Word, PowerPoint and Microsoft Project.Ability to think critically and creatively and be able to work independently to determine appropriate actions to resolve complex problems.Ability to demonstrate competencies applicable for job based on Xencor’s Leadership Competency Model.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.Occasional travel may be required, including travel between Xencor’s Pasadena and San Diego offices. Work for this position is generally performed at Xencor’s worksite and requires full-time commitment.
Expected Base Salary Range:
$155,000 to $180,000. The actual salary will be based on the selected candidate’s qualifications, including skills, competencies, education and experience. Xencor offers a competitive total rewards package including 401k match, healthcare coverage, ESPP and a broad range of other benefits. In addition, this position will be eligible for an annual bonus and equity grant. For more information, please see
https://xencor.com/careers/ .
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. New employees will be required to provide proof of their COVID-19 vaccination 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 .
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.
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