Temp - Sr. Manager Clinical Drug Supply & Logistics

This role requires 4-days onsite in either Amronk NY or Basking Ridge NJ. Fully remote is not eligible.

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

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.

Does this sound like you Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits which often include (depending on location) health and wellness programs fitness centers 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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment unless the accommodation would impose undue hardship on the operation of the Companys business.

For roles in which the hired candidate will be working in the U.S. the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S Japan or Canada please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity right to work educational qualifications etc.