Sr. Director, Clinical Supply Operations

Kezar Life Sciences is seeking a Sr. Director, Clinical Supply Operations responsible for developing and implementing clinical supply chain strategies, procedures, and infrastructure to support all activities related to managing supply of Investigational Product (IP). This includes packaging, labeling, and distribution through all stages of clinical development and coordinating with internal and external stakeholders to ensure timely and uninterrupted supply of IP, comparators, and background medications for Kezar clinical development studies. This position is not available for a remote hire as the expectation is to be onsite at our South San Francisco, 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, 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 now being studied in a Phase 1 clinical trial in several oncology indications.

• Lead the development of optimized distribution strategies for current and upcoming clinical trials
• Support Clinical Operations in contract negotiation, development, and ongoing maintenance of interactive response technology (IRT) and other systems used for the management of IP in clinical studies
• Work cross-functionally with Clinical Operations, CMC, Quality Assurance, and Regulatory Affairs to plan and ensure uninterrupted and compliant supply of Investigational Product (IP) for assigned clinical studies and Investigator Initiated Trials
• Work with Clinical Operations and CMC to define supply strategies for clinical study IP and other collaborative studies in line with study protocols
• Draft and actively manage supply forecasts based on documented Clinical Development requests.
• Develop, with CMC and Clin Ops clinical supplies projections based on patient enrollment and drug product inventory plans
• Provide guidance for development of clinical supply packaging and label design to accord with protocols, regulatory requirements, blinding/randomization concerns, and ease of handling by the sites/patients
• Ensure accurate demand signals and inventory levels are incorporated into overall supply plan for manufacture of API and IP
• Source and recommend and ultimately manage CMOs for the support of Clinical Supply manufacture (packaging, labeling and distribution (including but not limited to): Draft Request for Proposal (RFP)
• Negotiate and finalize contracts and budgets associated with the clinical supplies function.
• Develop and manage the planning, scheduling, and coordination of packaging and labeling projects to ensure the availability and timely delivery of clinical supplies
• Develop and manage reconciliation process for each study Review invoices for approval
• Identify and manage vendors for provision and distribution of comparator and background medications
• Serve as a person in plant during the manufacturing, packaging and labeling of clinical.
• supplies
• Serve as an IP subject matter expert in selected investigators meeting during the initiation of clinical development programs
• Support Quality Assurance in management of drug substance, drug product, and IP stability programs and retest/expiry date assignments and extensions
• Serve as an internal source of information in all related to Clinical Supplies function and provide regular updates to stakeholders and the Executive Management

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:

• BS or MS in Pharmacy, Chemistry, or related discipline combined with at least 10 years of experience in Clinical Supply Chain
• Thorough understanding of regulatory requirements for clinical supply distribution in US, EU, APAC, and LATAM including testing and labeling
• Thorough understanding of cGMP, GCP, and national/international transportation requirements for pharmaceutical materials
• Proven ability to build or optimize standard processes supporting supply chain strategies
• Extensive knowledge and understanding of bio/pharmaceutical clinical Phase 1-3 supply chain principles
• Demonstrated leadership and interpersonal skills that have enabled you to successfully hire, develop, and retain employees. This includes aligni