Senior Manager, Clinical Supply
Reporting Line: Vice President, Manufacturing and Supply Chain
Location: Victoria, BC or Home-based, West Coast preferred
Purpose of Position
The incumbent is responsible for managing Aurinia’s global clinical supply and distribution planning programs. To effectively manage the supply chain, the incumbent will be unblinded to all clinical studies.
Roles & Responsibilities:
- Manages supply planning and timelines to ensure alignment with study plans, timelines, and overall clinical development plan;
- Analyzes forecasted clinical drug requirements by product and converts forecasted requirements into a production/supply plan. Recommends lot sizes, safety stock levels and distribution lead times;
- Liaises with Contract Manufacturers and Material Suppliers regarding production scheduling and production issues and forwards forecasts, as per legal contract requirements;
- Coordinates material schedules (plans and manages efficient movement of clinical supplies);
- Proactively identifies and analyzes material supply challenges, constraints and identifies opportunities to lead projects and drive improvements;
- Establishes and maintains inventory management policies (IP expiration dating);
- Objectively analyzes and evaluates supply scenarios, options, and trade-offs. Develops strategic recommendations;
- Responsible for working within established procedures and timelines of investigational product manufacturing, labeling, Quality, release, distribution and returns/destruction;
- Oversees setup and management of IWRS systems, inventory tracking, patient assignment tracking, and bulk depot supply shipments;
- Extensive knowledge and experience with Interactive Response Technologies (IRT / IWRS); Works with cross-functional teams to develop specifications and user testing of IRT systems provided by 3rd party vendors. Leads effort for clinical supply management functionality; monitors and manages clinical supply activities through IRT from study start-up through study closure;
- Reviews drug return and destruction records; communicates with investigator sites, CROs and external vendors to resolve issues.
- Ensures appropriate documentation of IP supply activities is provided to clinical trial teams for the Trial Master File. Provides input to drug kit randomization specifications and reviews blinded master kit lists; reviews IWRS specifications and IWRS user manuals;
- Represents Clinical Logistics/Supply Management and coordinates with cross-functional stakeholders including Manufacturing, Quality, Regulatory, Clinical Operations, IWRS vendor, Finance and others to align on assumptions and plans that impact demand and supply;
- Leads management of IP service vendors (performance, quality, timelines, deliverables, costs); participates in preparation of RFP, assumptions and SOW for CROs and IP services vendors (labeling, packaging, distribution, IWRS);
- Reviews and approves/scrutinizes specified costs on vendor invoices against contracts.
- Bachelor's degree and at least 10 years of relevant experience in the biotechnology/pharmaceutical industry, with 3 years minimum in clinical supply management.
- Experience developing clinical trial drug supply plans and being unblinded representative for trials.
- Investigational Product forecasting skills and working knowledge of the clinical drug development process.
- Knowledge of GMP’s, ICH/GCP and regulatory guidelines/directives.
- Ability to effectively multi-task, prioritize and problem solve.
- Excellent interpersonal, written and verbal communication skills.
- Demonstrated Project management and organizational skills.
- Expertise in use of MS Excel, as well as proficiencies in ERP systems and other applications Study Tools including IWRS, CTMS.
- Some travel (20%) is required to develop and maintain good relationships with vendors.
Please fill out the form below to submit your application.