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Manager Clinical Drug Supply & Logistics

Regeneron Pharmaceuticals, Inc.
Basking Ridge, New Jersey
Start date
Jan 6, 2023

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Job Details

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).

In this role, a typical day might include:

  • Serves as lead drug supply manager for the functional area in supply planning, including demand forecasting according to IOPS requirements.
  • Leads supply planning and timelines to ensure alignment with study plans and timelines and overall clinical development plan.

  • Identifies 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.  

This role might be for you if you have experience with:

Inventory tracking, Shipments, IVRS, Returns & Destruction, Expire Management, Ancillary & Comparator Supplies, Documentation, Study Team Interaction, Budget Management, Vendor & Staff Management, Process Initiatives, Metrics, Training and Reporting including:

  • Is responsible for 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, to ensure timely and compliant shipment and delivery to investigator sites.
  • Solid understanding 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 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 team and Clinical Trial teams of pending IP expiry.
  • 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.
  • Provides feedback 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.
  • 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; 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.
  • 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, results, 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.
  • Supervises 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

To Be considered for this opportunity, you must have the following:

  • Bachelor's Degree with at least 5 years of relevant experience in the biotechnology/pharmaceutical industry, with 3 years minimum in clinical supply management OR a Masters/MBA/PharmD with 3+ years of relevant industry experience.
  • May require 25% travel



Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!

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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)

$108,200.00 - $176,600.00


Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Regeneron Pharmaceuticals, Inc.
Corporate Headquarters
777 Old Saw Mill River Road
New York

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