Description

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.

In order to be considered qualified for this role, 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.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include 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, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.

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 Company's 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.

Salary Range (annually)

$134,400.00 - $219,200.00

Senior Manager Clinical Drug Supply & Logistics

Description

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