Clinical Trial Manager

Clinical Trial Manager

Kezar is a clinical-stage biotechnology company developing breakthrough treatments for immune-mediated and oncologic disorders. Kezar's lead product candidate, zetomipzomib, is being evaluated in clinical trials for the treatment of lupus nephritis (LN) and autoimmune hepatitis (AIH). Kezar is also conducting an oncology clinical trial of KZR-261, the first candidate from its novel platform targeting the protein secretion pathway.

We are seeking an experienced Clinical Trial Manager to support its investigational drug programs. The CTM will support the planning, executing, driving, and reporting for assigned study(ies). Remote candidates will be considered; however, the preference is for local candidates who can be onsite at our South San Francisco, CA office at least three days per week.

Key Responsibilities include:

• This position may supervise one junior staff member.

• Works with Sr. Clinical Trial Manager and/or Associate Director to manage the entire process of a clinical trial, with the ability to identify issues and adapt to changes.

• Interacts with cross-functional teams internally and externally to ensure trial progress.

• Will incorporate study logistics and planning to accomplish study objectives.

• Will serve as the primary point of contact for CROs, addressing questions and applying knowledge to resolve problems.

• Demonstrates desire and ability to manage CTAs and CRAs. Demonstrates an ability to interact with contacts cross-functionally at senior levels within the Company.

• Demonstrates an ability to manage studies or programs of higher complexity from both a process and strategic perspective.

• Coordinates and manages all aspects of a clinical study. May monitor clinical trial sites.

• Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures, and clinical study reports.

• Maintains study timelines.

• Contributes to development and maintenance of study budget.

• Contributes to development of RFPs and participates in selection of CROs/vendors.

• Manage CROs/vendors.

• Coordinates review of data listings and preparation of interim/final clinical study reports.

• Ensures effectiveness of site budget/contract process.

• May be asked to train CROs, vendors, investigators, and study coordinators on study requirements.

• Assists in determining the activities to support a project's priorities within functional area.

• Excellent teamwork, communication, decision-making and organizational skills are required.

• Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.

• Must be able to generally understand, interpret, and explain protocol requirements to others.

• Must be able to prioritize multiple tasks.

• May serve as a resource for others within the company for clinical trials management expertise.

• Under general supervision, is able to examine functional issues from an organizational perspective.

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 relevant scientific field or related discipline

• 6+ years of Clinical Research experience in the pharmaceutical and/or biotechnology industry (including 3+ years direct experience managing clinical studies)

• Sound computer skills: proficient in the use of Excel, Word, and PowerPoint; experienced with EDC and IRT systems

• Ability to work with a high degree of initiative and independence while exercising appropriate judgement when direction is required

• Strong multi-tasking skills and ability to balance multiple deadlines and competing priorities

• Strong organizational, communication (oral and written) and interpersonal skills

• Experience monitoring clinical trials, a plus

• Thorough knowledge of ICH/GCP guidelines and FDA requirements for INDs and NDAs

• Must be flexible and able to prioritize, meet deadlines in a fast-paced environment, and be adaptable to setbacks. Exceptional problem-solving skills

• Team oriented. Able to work collaboratively with internal colleagues & external vendors.

• Ability to travel up to 20% domestic and/or international

Compensation and Benefits

The salary range for this position at our South San Francisco, CA corporate office is $138,000 - $146,000. Additional 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 novel treatments that can better the lives of patients fighting difficult-to-treat chronic diseases.

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.