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About the Role

The Senior Manager, Clinical Drug Supply & Logistics is responsible for overseeing clinical programs, forecasting Investigational Product (IP) supply requirements, and managing the IP distribution process for clinical trials. This role ensures activities are performed on time, within budget, and with good quality, in compliance with regulations and company SOPs. It also contributes to process improvement initiatives and applies to both internally sourced and CRO/Partnered studies.

Responsibilities

Serves as lead drug supply manager for a program and/or individual studies, including demand forecasting.
Manages supply planning and timelines to ensure alignment with study plans 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 and study/pharmacy manuals.
Responsible for working within established timelines of investigational product manufacturing, labeling, release, distribution, and return/destruction, or helping to establish these timelines.
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.
Oversees IP shipment orders according to supply plans or as requested by Clinical Trial Management team.
Works with Clinical Logistics Associate to complete shipment activities or manages all aspects of the process.
Works with cross-functional teams to develop specifications and support user testing of IRT systems.
Leads effort for clinical supply management functionality.
Monitors and manages clinical supply activities through IRT from study start-up through study closure.
Develops strategy and oversees drug return and destruction activities.
Develops resupply strategies based on stability and shelf-life of clinical supplies.
Monitors IP expiry data and informs Clinical Supply and Clinical Trial teams of pending IP expiry.
Coordinates with other functional areas to define ancillary and/or comparator supply strategy.
Develops plans for supplying clinical study sites with ancillary and/or comparator supplies.
Provides input to drug kit randomization specifications and reviews and approves master kit lists.
Designs, reviews, and approves IP-related study tools.
Supports inspection team in preparation for and during regulatory agency inspection.
May represent Clinical Drug Supply & Logistics during regulatory agency inspections.
Represents Clinical Drug Supply & Logistics on cross-functional study team(s).
Prepares or provides input into IP-related content for training materials and coordinates training on study procedures.
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.
Acts as point of escalation for IP-related issues.
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.
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.
Provides input, reviews, and approves vendor study specifications for IP-related activities.
Serves as point of escalation for vendor-related IP issues.
May require 25% travel.
May supervise staff.
May mentor or coach junior Clinical Drug Supply & Logistics staff.
Develops and implements process initiatives in accordance with business needs.
Tracks metrics related to drug supply processes and staff.
Provides assistance in training and development as needed.
Compiles and reports supply status to study teams and senior management.
Applies knowledge of company policies and standard practices to resolve problems.

Requirements

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

Skills

Clinical Drug Supply Management
Demand Forecasting
Inventory Management
Shipment Coordination
Interactive Response Technologies (IRT)
Budget Management
Vendor Management
Process Improvement
Regulatory Compliance
Cross-functional Collaboration
Problem Solving
Communication

Location

Armonk, NY
Warren, NJ
Cambridge, MA

Work Type

in office 3-4 days per week
On-site

Experience Level

Senior Manager
8 years of relevant experience
5 years minimum in clinical supply management
5+ years of relevant industry experience (for Masters/MBA/PharmD)

Education Level

Bachelors' degree
Masters/MBA/PharmD

Salary/Compensations

$134,400.00 - $219,200.00

Benefits

annual bonuses or other incentive plans
equity awards
pension or retirement benefits
401(k) company match
health and wellness programs
fitness centers
insurance benefits (e.g. medical, dental, vision, life and disability)
paid time off
family support benefits

About the Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases.
Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development.
Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases.
Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

Equal Opportunity

We are committed to building a workplace with an inclusive culture.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.
Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based.
The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.