Trial Master File Specialist / Manager

As part of the Clinical Operations team, the TMF Specialist supports the development and implementation of procedures, processes, systems, and training to ensure TMF setup, maintenance, tracking, and archival over the study lifecycle in compliance with SOPs, ICH GCP, and regulatory requirements. The TMF Specialist is a cross-functional role that interacts with internal and external stakeholders (e.g., Study Execution Team and CROs). The expectation is that the TMF Specialist will be onsite at our South San Francisco, CA office at least three days per week.

Kezar is focused on small-molecule drug discovery and development to target immune-mediated diseases and cancer. Kezar's lead product candidate, zetomipzomib, is being evaluated in clinical trials for the treatment of lupus nephritis and autoimmune hepatitis. Kezar is also conducting an oncology clinical trial of KZR-261, the first candidate from its novel platform targeting the protein secretion pathway. This research platform has the potential to generate additional small molecule compounds with therapeutic potential in cancer and inflammation.

Key Responsibilities include:

• Support the development of key TMF processes including SOPs, templates, and tools, TMF process training, and best practices
• Assist cross-functional TMF content contributors in day-to-day activities, issue resolution, and TMF reviews
• Support quality oversight for Kezar and CRO TMFs and remediation activities
• Support the development and management of TMF status reports and compliance metrics
• Ensure consistency in TMF implementation and compliance with standards and processes
• Partner with the vendor(s), Systems Administrator, and QA for TMF periodic releases or enhancements and CRO/vendor TMF migrations
• Submit user access requests and participate in the periodic review of access
• Prepare meeting agendas and minutes
• Other duties as required
• Bachelor's degree in a scientific discipline combined with 5+ years of experience in the pharmaceutical, biotechnology, or CRO industry. Candidates at the manager level would be expected to have additional years of relevant experience
• Minimum of 3 years GCP document management experience
• Experience in TMF including electronic TMF systems, Veeva Vault eTMF experience preferred
• Demonstrated understanding of the TMF Reference Model
• Knowledge of ICH-GCP, FDA, and EU requirements as applicable to TMF and Good Documentation Practices
• Proficiency in MS Office suite
• Excellent written and verbal communication skills
• Detail-oriented

Not sure if you are qualified for this position? We know that skills and experience can show up in different ways and we welcome resumes from a broad range of applicants. You are encouraged to apply even if you do not meet each of the listed preferred qualifications.

Preferred Qualifications Include:

Compensation and Benefits

The salary range for this position as TMF Specialist at our South San Francisco, CA corporate office is $115,000 - $125,000. The salary range for candidates at the Manager level is $130,000 - $140,000. Factors such as academic credentials and relevant experience will influence the actual salary offered. In addition to a competitive market-based salary, Kezar Life Sciences offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package including 401K. Additional information about our total rewards program can be found here: Join Our Team - Kezar Life Sciences Inc.

About Kezar Life Sciences

We are developing first-in-class, small molecule therapies designed to inhibit multiple disease-driving cellular pathways by targeting key intracellular proteins. Since inception, our mission has been to deliver unique treatments that can better the lives of patients fighting difficult-to-treat chronic diseases. Our team is passionate about discovering promising targets that were previously unidentified or undruggable and have the potential to change the treatment paradigm for a range of conditions.

Here at Kezar, our employees are our greatest asset and are the drivers of the Company's success. Every day, our team of passionate professionals are converting scientific ideas to first-in-class assets that have the potential for significant clinical impact in the most difficult-to-treat diseases. Together, we are focused on the common mission of helping patients overcome their chronic conditions and live a better life.

We believe in fostering a culture of trust and respect for all team members at all levels. Our employees are encouraged to question, exchange views and discover new ways to address issues and solve problems. We welcome differences in ideas, styles and practices to accomplish our goals. Hard working, innovative and compassionate are qualities every Kezar employee should possess and we're always looking for equally dynamic and motivated individuals to join our team.

Information for Recruitment Agencies

Kezar Life Sciences does not accept from recruiters/agencies any unsolicited resumes, or any candidate information including blinded resumes and will not be responsible for any fees related to resumes or candidate information that is unsolicited. Please do not contact hiring managers or Kezar Life Sciences employees directly with any information related to a resume or a candidate. We handle all recruiting through our internal Human Resources team, and we will reach out to you directly should we wish to engage in a search. Your willingness to comply with this will significantly impact any decision we may make about doing business with you.

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