The Senior Manager, Clinical 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 and drives ongoing process improvement initiatives.
This role applies to internally sourced studies and/or CRO/Partnered studies. Collaborates and interacts with clinical trial managers, therapeutic area project managers, medical monitors, as well as staff from quality, clinical compliance, regulatory, formulations, and IOPS (CMC, external manufacturing, stability).
- Serves as lead logistics manager 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 logistics 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; Oversees setup and management of IVRS (IWRS)
- Manages and tracks investigational product (IP) inventory; advises supply management team of potential shortages and makes recommendations for resupply activities based on usage trends.
- 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.
- Extensive knowledge and experience with Interactive Response Technologies (IRT) such as IVRS and IWRS; Work with cross-functional teams to develop specifications and user testing of IRT systems provided by 3rdparty vendors. Lead effort for clinical supply management functionality; Monitor and manage clinical supply activities through IRT from study start-up through study closure; Ensure appropriate system documentation is transferred to Regeneron for TMF and inspection readiness.
- Reviews and evaluates temperature excursion data and communicates stability information to clinical trial managers, CROs, and investigator sites; provides assessments to supply management team regarding excursion trends in each study.
- Reviews drug return and destruction records; communicates with investigator sites, CROs and external vendors to resolve issues.
- Authorizes final destruction of drug returns to 3rdparty vendor.
- Monitors IP expiry data and informs Clinical Supply team and Clinical Trial teams of pending IP expiry.
- Develop plans for supplying clinical study sites with ancillary supplies, either through in-house initiated supply or working with supply vendors.
- Ensures appropriate documentation of IP supply activities is provided to clinical trial teams for the Trial Master File. Provides input to drug kit randomization specifications and reviews and master kit lists; Reviews IVRS specs and reviews IVRS user manuals; Designs, reviews and approves IP-related study tools (for clinical study teams and investigative site use), as needed. Supports inspection team in preparation forand during regulatory agency inspection.
- Represents Clinical Logistics/Supply Management on cross-functional study team (s) and/or sub-team(s); Provides input into budgets, SoWs, contracts and timelines for IP-related services; 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.
- 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; Serves as point of escalation for vendor-related IP issues as they arise; Reviews and approves/scrutinizes specified costs on vendor invoices against contract, as delegated; Recommends vendors to IOPS and Clinical Study Teams.
- Bachelors Degree
- 6 years of relevant experience in the biotechnology/pharmaceutical industry, with 3 years minimum in clinical supply management
- Some line management experience, if applicable
- Experience developing trial drug supply plans
- Investigational Product forecasting skills
- Working knowledge of the clinical drug development process and clinical trial methodology
- Knowledge of ICH/GCP and regulatory guidelines/directives
- Study Tools including electronic system skills IVRS/IWRS, CTMS, EDC
- Disease/therapeutic area knowledge (a plus)
- Understands current and future business trends and information
- Leadership and negotiation skills
- Mentoring/coaching skills
- Ability to effectively multi-task and prioritize
- Effective problem solving skills
- Written and verbal communication and presentation skills in small and large group settings
- Project management and organizational skills
- Computer skills, with competency in MS Word, Excel
- Interpersonal skills; Cross functional and cross-cultural awareness
- Ability to work in a matrix environment
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 amazing benefits including health and wellness programs, fitness centers and stock 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.