Sr. 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
• 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 phase 1 study management experience; candidates with experience managing all aspects of a fully outsourced phase 1 renal impairment study will be considered uniquely qualified for this role
• Experience 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

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 phase 1 study management experience; candidates with experience managing all aspects of a fully outsourced phase 1 renal impairment study will be considered uniquely qualified for this role
• Experience 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 $155,000 - $165,000. 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.