Clinical Supplies Manager – Tocagen Inc. – San Diego, CA, USA
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, QA, Manufacturing, Quality Control and Regulatory teams. The CSM will manage all vendors involved in the planning, distribution, storage and destruction of Clinical trial supplies to Clinical investigational sites. In addition to study drug and ancillary supplies, this position also encompasses interactions with specialty labs for the distribution of lab kits and receipt/storage of specimens, and other vendors that may be contracted for specialized central study services.
Duties and Responsibilities Include But Are Not Limited To:
• Coordinate the planning, creation and maintenance of Investigational Medicinal Product (IMP) based on study and drug forecasts with Clinical, Manufacturing and Medical project managers
• Accountable for the scheduling and timely delivery of packaged IMP including randomization, packaging, labeling, and global distribution of clinical supplies
• Work collaboratively with other departments for the creation and approval of product labeling. Manage/execute labeling and packaging operations with vendors. May negotiate supply/technical agreements, and act as primary liaison between clinical personnel and contractor(s) on assigned projects
• Support the development and implementation of IXRS supply and drug return strategy with contractors and sites
• Process manual orders for IMP and supplies 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 accurately completed
• Assist with developing Standard Operating Procedures (SOPs) and guidelines related to inventory management, distribution, transportation, and disposition of returned/unused materials. Development of SOPs and evaluation of tools to support outsourcing oversight and study processes
• Ensure that key supply project milestones are met while maintaining open communication on supply plan timelines with internal and external customers and partners
• Proactively drive cross-functional activities working with internal and external line functions
• Selection and management of vendors for the supply of centralized services such as clinical trial supply companies, specialty labs, central medical test suppliers
• Oversee vendors from start-up to close-out including budget negotiation process and finalization, and ensure study budgets are managed to plan and scope
• Coordinate the provision of lab kits to sites and tracking of samples back to labs, delivery of test results and sample storage/destruction as required by protocol
• Work closely with Clinical Project Managers to ensure timely and adequate supply to all clinical trial sites
• 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
• Participate in design and implementation of interactive response systems
• Track and manage temperature data associated with shipments of clinical drug supplies
• Develop SOPs and guidelines to deal with temperature and other shipping excursions.
• Ensure that all documentation of product and test article accountability is present in trial master file and submission ready
• Coordinate regular clinical supply meetings with cross functional teams.
• Performs other duties as required.
Reports To: Vice President, Clinical Operations
Position Type: Salaried, negotiable according to experience and fit; package includes company stock options, as well as tax advantaged employee benefit plans.
Requirements Desired Knowledge and Abilities:
• Well organized with strong technical skills, solid written and verbal communication skills, computer skills, and proven ability to multitask
• Excellent leadership and interpersonal skills with an ability to effectively work within a multidisciplinary team and to effectively 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 and multi-task in order to thrive in small company environment
• Demonstrated ability to effectively negotiate contracts and financial terms
Education and 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.