Onsite 4 times per week out of Pasadena OR San Diego, CA
The Position
This role is responsible for the planning and management of investigational medicinal product (IMP) and ancillary supplies needed to ensure uninterrupted patient dosing for assigned clinical studies. This role will create and maintain study forecast and supply plans, develop clinical labels, execute packaging and labeling activities, manage distribution, inventory, and returns & reconciliation of clinical studies.
Responsibilities
- Collaborate cross-functionally with Clinical Operations, Manufacturing, Regulatory Affairs, and Quality Assurance to forecast, plan, and execute IMP supply plans including IMP utilization, labeling and packaging, inventory control, and depot management for assigned clinical studies
- Develop, update, and adapt clinical supplies distribution plans based on program and study timelines, trial design, clinical program changes, recruitment, geography, and manufacturing schedules
- Develop plans for ancillary supply sourcing and liaise with CMC team to ensure ancillary compatibility with IMP
- Develop and manage SOPs, work instructions, processes, systems, and forms governing clinical supplies management in alignment with industry standards and regulatory requirements
- Work with cross functional team including Clinical Operations and Quality Assurance to manage IMP shelf-life extensions, temperature deviation management, product complaints, and associated investigations
- Identify potential supply chain vendors and review proposals contributing to the selection process
- Oversee aspects of Arrowhead's global network of clinical CMOs supporting clinical drug supply. Scope of work includes management of drug from the release of Drug Product (DP) at the filling site through release of Final Packaged Goods (FG) at the label/pack site (or depot in some cases); scheduling and oversight of label/pack execution activities at the label/pack site; and ensuring the necessary materials and components are available for execution
- Collaborate with internal cross-functional teams to determine manufacturing requirements. Drive contract manufacturer capability and capacity to enable on- time and predictable delivery of packaged clinical product
- Manage the operational pack activities (schedule, timelines, etc.) of the CMO ensuring program cost, quality, metrics, delivery, and technology objectives are met as well as manage the partner performance to achieve them. Proactively intercede if goals and timelines are jeopardized, communicating to appropriate stakeholders as needed
- Partner with key stakeholders in the preparation for Requests for Quotes (RFQs), Statements of Work (SOW) and negotiate supply agreements for clinical programs
- Serve as the manufacturing outsourcing team leader on cross-functional teams as requested in support of clinical finished good packaging
- Support QA in establishing QA agreements with all CMO's and assuring that Product Specific Requirements (PSR's) are established before projects are initiated
- Apply advanced theory, technical principles, expert judgment, and cross-functional expertise to independently address a broad range of complex problems
- Identify and champion process improvement solutions to complex issues with inter- organizational impact
Requirements:
- 4-year college degree (relevant discipline preferred)
- Minimum of 3-4 for Manager and 6 years for Sr. Manager in a clinical supply chain management function
- Thorough understanding of GMP, GCP, and ICH standards governing IMP labeling, packaging, and global distribution
- Experience with electronic interactive response technologies for inventory management
- Strong vendor management skills
- Ability to proactively perform and complete duties with minimal supervision in an accurate and timely manner
- Proficient in MS Office (Word, Excel, and PowerPoint)
- Ability to work in a team or independently
- Effective interpersonal, written, and verbal communication skills
- Able to critically evaluate and prioritize job tasks and the impact on overall study execution
- Strong problem-solving capabilities
- Effectively collaborates with cross-functional team members
- Exceptional organizational skills with the ability to multi-task and prioritize
- Attention to detail
