Director, Clinical Science

Kezar Life Sciences (NASDAQ: KZR), a clinical-stage biotechnology sciences company located in South San Francisco, is seeking a Director, Clinical Scientist.

Kezar is focused on small molecule drug discovery and development to target immune-mediated diseases and cancer. Kezar's lead product candidate, KZR-616, a selective inhibitor of the immunoproteasome, is being evaluated in Phase 2 clinical trials for the treatment of severe autoimmune diseases. KZR-261, Kezar's first oncology candidate targeting the protein secretion pathway via the Sec61 translocon, is in Phase 1 clinical trials in several oncology indications.

Responsibilities:

This position will report to the VP of Clinical Development and will provide leadership, strategic planning, execution, and operational oversight of clinical development programs for the company's studies. The Director will identify and implement best practices in trial management and execution.

• Develop synopsis and protocols for clinical studies
• Prepare clinical development plans
• Draft and review clinical scientific documents such as IND, IND amendments, Investigator Brochures, Development Safety Update Report, other FDA submissions, Informed Consent Form, monitoring plan and other key study documents
• Monitor, review and summarize safety and efficacy data in ongoing studies
• Represent Clinical Science in collaborative program level, including cross-functional activities
• Develop and maintain relationships with appropriate consultants
• Write abstracts and present data at scientific meetings, both internal and external
• Serve as liaison to project teams, CRO's and others

• Train and support study staff and CRAs/CRO on study protocol and related questions and may serve as a point of contact or backup for managing/answering questions relating to clinical aspects and subjects' eligibility
• Performs clinical sciences-related contributions to development of Case Report Forms (CRFs), CRF completion guidelines, data review reports, and trial statistical analysis

Qualifications:

• Degree in scientific/life-sciences field. MD, Pharm.D. or Ph.D. preferred
• Minimum of 4 - 6 years of experience in research with at least 3 or more years of drug development experience is required
• Prior immunology/autoimmune drug development experience a plus
• Ability to multi-task and work in a fast-paced environment
• Fluency in English and excellent written and oral communication skills
• Strong analytical ability
• Knowledge of Good Clinical Practice; comprehensive knowledge of clinical trial design; understanding of the overall global drug development process

Kezar Life Sciences is an equal opportunity employer.