The Manager, Clinical Drug Supply & Logistics is responsible for forecasting Investigational Product (IP) supply requirements for multiple clinical trials and for managing the IP distribution process to one or more clinical trials. Activities are performed on time, within budget and with good quality, in compliance with Regulatory Authorities’ regulations / guidelines and Regeneron SOPs / WPDs.Contributes to ongoing process improvement initiatives. This role applies to internally sourced studies and/or CRO/Partnered studies. Collaborates and interacts with clinical trial managers, development program managers, medical monitors, as well as staff from quality, clinical compliance, regulatory, formulations, and IOPS (CMC, external manufacturing, stability).
Supply Planning
1. Serves as lead drug supply manager for the functional area in supply planning, including demand forecasting according to IOPS requirements.
2. Manages supply planning and timelines to ensure alignment with study plans and timelines and overall clinical development plan.
3. Works with clinical drug supply management to determine resourcing needs.
4. Provides input to the development of IP-related study documents including protocols, study and pharmacy manuals.
5. Responsible for working within established timelines of investigational product manufacturing, labeling, release, distribution and return/destruction, and/or helping to establish these timelines.
Inventory tracking
6. Manages and oversees investigational product (IP) inventory strategy; advises supply management team of potential shortages and defines resupply activities based on usage trends and projections.
Shipments
7. Oversees IP shipment orders according to supply plans or as requested by Clinical Trial Management team, to ensure timely and compliant shipment and delivery to investigator sites. Works with Clinical Logistics Associate to complete this activity and/or manages any/all aspects of the process.
IVRS
8. Working knowledge and experience with Interactive Response Technologies (IRT) such as IVRS and IWRS.
9. Works with cross-functional teams to develop specifications and support user testing of IRT systems provided by 3rd party vendors.
10. Leads effort for clinical supply management functionality.
11. Monitors and manages clinical supply activities through IRT from study start-up through study closure.
Returns & Destruction
12. Develops strategy and oversees drug return and destruction activities.
Expiry Management
13. Develops resupply strategies based on stability and shelf-life of clinical supplies.
14. Monitors IP expiry data and informs Clinical Supply team and Clinical Trial teams of pending IP expiry.
Ancillary & Comparator Supplies
15. Coordinates with other functional areas, including Regulatory, Medical Director, Forecasting & Planning, and IOPS to define ancillary and/or comparator supply strategy.
16. Develops plans for supplying clinical study sites with ancillary and/or comparator supplies, either through in-house initiated supply or working with supply vendors.
Documentation
17. Provides input to drug kit randomization specifications and reviews and approves master kit lists
18. Designs, reviews and approves IP-related study tools (for clinical study teams and investigative site use), as needed.
19. Supports inspection team in preparation for and during regulatory agency inspection.
Study Team Interaction
20. Represents Clinical Drug Supply & Logistics on cross-functional study team (s) and/or sub-team(s).
21. Prepares or provides input into IP-related content for training materials and coordinates training on study procedures; In collaboration with the CTM for study, provides input into IP-related study specific working practices; Establishes study team contacts, roles, responsibilities, and objectives for IP-related services; Develops, manages, and maintains relationships with external partners; Effectively communicates with CROs, shipping and IVRS vendors, study sites and study team members to ensure ongoing successful execution; Acts as point of escalation for IP-related issues.
Budget Management
22. Provides input into budgets, SoWs, contracts and timelines for IP-related services.
23. Creates RFPs, reviews quotes, and awards third-party vendors for distribution services.
24. Responsible for distribution vendor budget management (invoice review/approval, change orders, reconciliation); reviews and approves/scrutinizes specified costs on vendor invoices against contract, as delegated.
Vendor Management
25. Leads management of IP service vendors (performance, quality, timelines, deliverables, costs)
26. Participates in preparation of RFP, assumptions and SOW for CROs and IP services vendors (labeling, packaging, distribution; IVRS/IWRS)
27. Provides input, reviews, and approves vendor study specifications for IP-related activities.
28. Serves as point of escalation for vendor-related IP issues as they arise.
29. May require 25% travel
Staff Management
30. Does not supervise staff.
31. May mentor or coach junior Clinical Drug Supply& Logistics staff.
Process Initiatives
32. Develops and implements process initiatives in accordance with business needs.
Metrics
33. Tracks metrics related to drug supply processes and staff.
Training
34. Provides assistance in training and development as needed.
Reporting
35. Compiles and reports supply status to study teams and senior management
Problem solving
36. Applies knowledge of company policies and standard practices to resolve problems.
In order to be considered for this role, a minimum of bachelor's degree and at least 6 years of relevant experience in the biotechnology/pharmaceutical industry, with 3 years minimum in clinical supply management. A Masters/MBA/PharmD with 3+ years of relevant industry experience is preferred