Senior Manager Clinical Drug Supply & Logistics

Regeneron Pharmaceuticals

1d

About The Position

The Senior Manager, Clinical Drug Supply & Logistics is responsible for providing oversight of individual or multiple clinical programs, 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 Serves as lead drug supply manager of a program and/or individual studies for the functional area in supply planning, including demand forecasting according to IOPS requirements. Manages supply planning and timelines to ensure alignment with study plans and timelines and overall clinical development plan. Works with clinical drug supply management to determine resourcing needs. Provides input to the development of IP-related study documents including protocols, study and pharmacy manuals. 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 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 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 Working knowledge and experience with Interactive Response Technologies (IRT) such as IVRS and IWRS. Works with cross-functional teams to develop specifications and support 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. Returns & Destruction Develops strategy and oversees drug return and destruction activities. Expiry Management Develops resupply strategies based on stability and shelf-life of clinical supplies. Monitors IP expiry data and informs Clinical Supply team and Clinical Trial teams of pending IP expiry. Ancillary & Comparator Supplies Coordinates with other functional areas, including Regulatory, Medical Director, Forecasting & Planning, and IOPS to define ancillary and/or comparator supply strategy. 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 Provides input to drug kit randomization specifications and reviews and approves master kit lists. Designs, reviews, and approves IP-related study tools (for clinical study teams and investigative site use), as needed. Supports inspection team in preparation for and during regulatory agency inspection. May represent Clinical Drug Supply & Logistics during regulatory agency inspections. Study Team Interaction Represents Clinical Drug Supply & Logistics on cross-functional study team (s) and/or sub-team(s). 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 Provides input into budgets, SoWs, contracts and timelines for IP-related services. Creates RFPs, reviews quotes, and awards third-party vendors for distribution services. 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 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; IVRS/IWRS) Provides input, reviews, and approves vendor study specifications for IP-related activities. Serves as point of escalation for vendor-related IP issues as they arise. May require 25% travel Staff Management May supervise staff. May mentor or coach junior Clinical Drug Supply & Logistics staff. Process Initiatives Develops and implements process initiatives in accordance with business needs. Metrics Tracks metrics related to drug supply processes and staff. Training Provides assistance in training and development as needed. Reporting Compiles and reports supply status to study teams and senior management Problem solving Applies knowledge of company policies and standard practices to resolve problems.

Requirements

• A minimum of a Bachelor's degree and 8 years of relevant experience in the biotechnology/pharmaceutical industry, with 5 years minimum in clinical supply management.
• A Masters/MBA/PharmD with 5+ years of relevant industry experience is accepted.
• Working knowledge and experience with Interactive Response Technologies (IRT) such as IVRS and IWRS.

Responsibilities

• Oversight of individual or multiple clinical programs
• Forecasting Investigational Product (IP) supply requirements for multiple clinical trials
• Managing the IP distribution process to one or more clinical trials
• Serve as lead drug supply manager of a program and/or individual studies for the functional area in supply planning, including demand forecasting according to IOPS requirements
• Manage supply planning and timelines to ensure alignment with study plans and timelines and overall clinical development plan
• Manage and oversee investigational product (IP) inventory strategy
• Oversee 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
• Work with cross-functional teams to develop specifications and support user testing of IRT systems provided by 3rd party vendors
• Monitor and manage clinical supply activities through IRT from study start-up through study closure
• Develop strategy and oversee drug return and destruction activities
• Develop resupply strategies based on stability and shelf-life of clinical supplies
• Coordinate with other functional areas, including Regulatory, Medical Director, Forecasting & Planning, and IOPS to define ancillary and/or comparator supply strategy
• Provide input to drug kit randomization specifications and reviews and approves master kit lists
• Design, review, and approve IP-related study tools (for clinical study teams and investigative site use), as needed
• Represent Clinical Drug Supply & Logistics on cross-functional study team (s) and/or sub-team(s)
• Prepare or provide input into IP-related content for training materials and coordinates training on study procedures
• Provide input into budgets, SoWs, contracts and timelines for IP-related services
• Create RFPs, reviews quotes, and awards third-party vendors for distribution services
• Lead management of IP service vendors (performance, quality, timelines, deliverables, costs)
• Participate in preparation of RFP, assumptions and SOW for CROs and IP services vendors (labeling, packaging, distribution; IVRS/IWRS)
• Provide input, reviews, and approves vendor study specifications for IP-related activities
• May supervise staff
• Develop and implement process initiatives in accordance with business needs
• Track metrics related to drug supply processes and staff
• Provide assistance in training and development as needed
• Compile and report supply status to study teams and senior management
• Apply knowledge of company policies and standard practices to resolve problems

Benefits

• health and wellness programs (including medical, dental, vision, life, and disability insurance)
• fitness centers
• 401(k) company match
• family support benefits
• equity awards
• annual bonuses
• paid time off
• paid leaves (e.g., military and parental leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees