Reports To: Associate Director, Quality Control
Position Type: Salaried, negotiable according to experience and fit; package includes company stock options, as well as tax advantaged employee benefit plans.
Tocagen is a clinical-stage, cancer-selective gene therapy company focused on developing first-in-class, broadly applicable product candidates designed to activate a patient’s immune system against their own cancer from within.
Every member of our team plays a significant role in our success. Tocagen hires individuals who share our passion for ending cancer mortality and have exceptional talent that will contribute to this goal.
The Clinical Supplies Manager (CSM) will support the Clinical Supplies team’s activities related to Clinical Trial Material (Phase 1-4); cooperate with internal and external customers and partners in compliance with multinational regulations as well as internal procedures and GxP requirements. Responsible for supporting and/or managing complex studies requiring Clinical Supplies project management, forecasting, IXRS, distribution, and supply logistics such as packaging/labeling and global distribution. This position will interface with Clinical, Project Management, Regulatory, QA, Diagnostics, Manufacturing and Quality Control teams. The CSM will manage vendors involved in the planning, distribution, storage and destruction of Clinical trial supplies for Clinical investigational sites as required.
Duties and Responsibilities Include But Are Not Limited To:
- Prepare Clinical Trials Materials (CTM) supply forecasts based on projected needs of clinical trial study protocols
- Coordinate supply of CTM, based on study and drug forecasts, with Clinical, Manufacturing and Medical project managers, as well as contract distribution partners
- Manage CTM, both internally and with distribution partners, including packaging, labeling, and global distribution of clinical supplies
- Work collaboratively with other departments for the creation and approval of product labeling. Manage labeling and packaging operations with vendors. May negotiate supply/technical agreements, and act as primary liaison between Tocagen personnel and contractor(s) on assigned projects
- Support the development, implementation, and maintenance of IXRS systems
- Process manual orders for CTM to be shipped by from contractors for all studies operating outside of IXRS automated supply systems
- Maintain clinical supplies inventory for assigned projects by interfacing with vendor to ensure that inventory systems are kept up-to-date and that final product reconciliation is accurate
- Develop Standard Operating Procedures (SOPs) related to inventory management, distribution, transportation, and disposition of returned/unused materials. Develop SOPs and tools to support outsourcing oversight
- Ensure that key supply project milestones are met while maintaining open communication on supply plan timelines with internal and external customers and partners
- Select and manage vendors for the supply of centralized services such as clinical trial supplies distribution, specialty labs, central medical test suppliers
- Oversee vendors from start-up to close-out, including budget negotiation process, and ensure study budgets are managed to plan and scope
- Coordinate the provision of clinical lab kits to sites and tracking of samples back to labs, delivery of clinical test results and sample storage/destruction as required by protocol
- Ensure consistency of processes and documentation across multiple studies
- Lead efforts in designing and implementing off-site inventory storage for disaster recovery
- Work with QA and Lab Administration to maintain on-site IMP storage equipment in validated state
- Track and manage temperature data associated with shipments of clinical drug supplies
- Ensure that all documentation of product and test article accountability is present in trial master file and submission-ready
- Coordinate and lead regular clinical supplies logistics meetings with cross-functional teams to ensure accurate, open, and timely communication on supply and logistics issues across all applicable functional areas
- Performs other clinical supplies, logistics as well as data base management duties as required for Clinical and CMC Departments.
- Performs other duties as required.
Desired Knowledge and Abilities:
- Well-organized and detail-oriented with strong technical skills, solid written and verbal communication skills, and proven ability to multitask
- Excellent leadership and interpersonal skills with an ability to effectively work within a multidisciplinary team and manage multiple vendors
- Self-starter who works with a sense of urgency and acts as a good team player working with other disciplines
- Adaptability, flexibility, independence and resourcefulness to roll-up-sleeves in order to thrive in small company environment
- Demonstrated ability to effectively negotiate contracts and financial terms
- Ability to appropriately manage and maintain blinded study information
- Proficiency in Microsoft Word, Excel, and Project
Education & Experience:
- Bachelor’s degree in a relevant field and at least 5 years Clinical Operations experience including experience with import, export and IATA regulations, as well as supply and cold chain management.
- Strong understanding of CFR and ICH guidelines, regulations and guidelines governing conduct of clinical studies.