Senior Clinical Trial Manager

Kezar Life Sciences is seeking a Senior Clinical Trial Manager. This position will independently lead the planning, execution, and reporting of Phase 1b and/or Phase 2 trials for our lead compound, KZR-616 (a selective inhibitor of the immunoproteasome). This is an exciting opportunity to play a strategic role in the research and development of novel therapies for serious diseases. Due to the high growth of Kezar and the close working relationships you will need to build, the expectation is to be onsite at our South San Franciso, 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:

• Lead cross-functional teams through activities dedicated to study design and clinical trial execution
• Contribute to clinical study documentation including clinical protocols, investigator brochures, informed consents, case report forms, various study plans, and clinical study reports
• Ensure data quality by performing listing reviews per established plans/processes
• Participate in the selection and oversight of vendors and Investigators
• Manage study timelines and budget; proactively participate in budget setting, forecasting, and other aspects of financial management of the trial (vendor accruals and site payments)
• Proactively identify project risks and manage issues through resolution
• Cultivate and maintain effective relationships with CRO, other clinical vendors, and clinical site personnel
• Analyze information, and utilize prior clinical experience and problem-solving skills to ensure the best possible outcome for the clinical research program
• Support SOP and process development and improvement

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:

• Bachelor’s Degree in a relevant scientific field or related discipline combined with 8+ years of Clinical Operations experience in the biopharmaceutical industry. Preference is for candidates with clinical study management experience; candidates with experience managing all aspects of a fully outsourced phase 2 renal impairment study will be considered uniquely qualified for this role
• Experience in successfully managing vendors independently and the proven ability to lead and guide the work of others in a matrix environment
• Experience developing study execution strategies, risk mitigation, and successful site/country selection
• Demonstrated proficiency in the implementation, monitoring and management of clinical trials and broad cross-functional knowledge and understanding of clinical trial methodology
• Ability to work with a high degree of initiative and independence while exercising appropriate judgment when required
• Strong multi-tasking skills and ability to balance multiple deadlines and competing priorities
• Strong organizational, communication, and interpersonal skills to ensure that clinical study plans are transparent, and risks, issues, and results are clear to all stakeholders
• Experience monitoring clinical trials
• Thorough knowledge of ICH/GCP guidelines and FDA requirements for INDs and NDAs
• Able to work collaboratively across cultures and geographies
• Proficiency in MS Office Suite and experienced with EDC and IRT systems
• Willing to embrace change and work in a changing environment
• Ability to travel up to 20% domestic and/or international

Compensation and Benefits

The salary range for this position as Senior Clinical Trial Manager at our South San Francisco, CA corporate office is $170,000 - $180,000. 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: