Associate Manager, Clinical Drug Supply & Logistics

The Associate Manager, Clinical Drug Supply & Logistics provides support for and may be responsible for forecasting Investigational Product (IP) supply requirements for multiple clinical trials and for supporting and/or handling 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).

A typical day might include the following:

• Serves as lead drug supply manager of multiple small and/or less sophisticated clinical studies for the functional area in supply planning, including demand forecasting according to IOPS requirements and handle supply planning and timelines to ensure alignment with study plans and timelines and overall clinical development plan.

• Leads and is responsible for (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 and works with Clinical Logistics Associate to complete this activity and/or manages any/all aspects of the process.

• Provides input into budgets, SoWs, contracts, and timelines for IP-related services and crafts 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.

• Participates in preparation of RFP, assumptions, and SOW for CROs and IP services vendors (labeling, packaging, distribution; IVRS/IWRS) and provides input, reviews, and approves vendor study specifications for IP-related activities.

This role might be for you if:

• You have a confirmed understanding and experience with Interactive Response Technologies (IRT) such as IVRS and IWRS.

• You can supervise and handle clinical supply activities through IRT from study start-up through study closure.

• You can develop strategy be responsible for drug return and destruction activities.

To be considered for this opportunity you must have at minimum a Bachelor's Degree and at least 3 years of proven experience in the biotechnology/pharmaceutical industry, with 2 years minimum in clinical supply management.

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)

$92,500.00 - $150,900.00