Manager / Senior Manager, Clinical Data Management

Kezar Life Sciences is seeking a Manager, Clinical Data Management who will report to the Director Clinical Data Management. This position will oversee Data Management activities for Phase I-IV studies and ensure product and study level deliverables are completed on time, with high quality, and following corporate and regulatory requirements. This position will participate as an active multi-disciplinary team member to plan, lead, and execute the Data Management tasks required for Phase I-IV studies. Expert knowledge of FDA regulations and general industry standards is necessary to support departmental infrastructure development.

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:

• Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies; build effective relationships with CRO/vendor counterparts
• Review protocols for appropriate data capture, including electronic CRF design
• Lead database upgrades / migrations, including performing User Acceptance Testing
• Oversee / develop data management documents including but not limited to DMPs, CRFs, CRF Completion Guidelines, Edit Checks, UAT specifications, data flow, and integrity plans, and Data Review Plans
• Able to review and provide feedback to the multi-disciplinary team on other study documents, e.g., Protocol Deviation Management Plan, Statistical Analysis Plan, and vendor specifications
• Participate in regular team meetings and provide input when appropriate
• Understand critical tasks and milestones; ensure data management deliverables are met per study timelines
• Manage the clinical study budget, ensuring the project remains within scope through reviewing and approving invoices, identifying out-of-scope activities, and its appropriate handling
• Conduct CRO data management function inspections and audits
• Contribute to developing and implementing departmental policies, standards, and process improvement initiatives
• Provide input into the development of data management SOPs, Work Instructions, and process documents
• Support implementation of data standards
• Align with and support management and corporate objectives
• Communicate and message information to multiple levels of leadership appropriately and apply the appropriate level of detail to the audience to ensure efficient utilization of resources
• Assist in selecting vendors / CROs (e.g., reviewing RFPs, and attending site audits). Assist with training of new employees and / or contractors

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:

• Bachelor’s degree in a scientific or health care discipline; Master’s degree is a plus combined with 5+ years of experience in Data Management in the pharmaceutical / biotechnology industry. Candidates at the Sr. Manager level would be expected to have additional years of relevant experience. Equivalent experience in an FDA- regulated environment, including study lead experience will be considered
• Technologically savvy; quickly picks up on new information, standards, regulations, tools, methods, or software related to position and profession
• Possesses a comprehensive understanding of regulatory guidelines and industry standards (e.g., ICH / FDA guidance, CDISC Standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, EDC Development, UAT, etc.) and their application to Data Management practice
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors
• Possess solid computer system and technical skills with a strong ability to learn multiple computer applications
• Understands the scope and focus of Phase I-IV clinical studies and has a proven ability to perform most of the core Data Management tasks and interact with vendors
• Prior experience with different Data Management systems, technologies, Electronic Data Capture systems, and IRT- Medidata Rave, Medrio, Endpoint, Bracket- is desirable
• Ability to lead, train, and mentor team members at all levels
• Able to travel to off-site meetings or training seminars as needed and under current COVID-19 guidelines

Compensation and Benefits

The salary range for this position as Manager, at our South San Francisco, CA corporate office is $155,000 - $165,000. The salary range for this position at the Senior Manager level is $180,000-$190,000. 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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