Senior Manager, Clinical Drug Supply Forecasting and Planning

The Senior Manager, Clinical Drug Supply Forecasting and Planning is responsible for forecasting Investigational Product (IP) supply requirements and for handling the IP distribution process for multiple clinical trials. We are looking for a strong collaborator to interact with clinical trial managers, therapeutic area project managers, medical monitors, and staff from quality, clinical compliance, regulatory, formulations, and IOPS (CMC, external manufacturing, stability). We need an individual to drive ongoing process improvement initiatives for internally sourced studies and/or CRO/Partnered studies.

In this role a typical day might include:

• Serving as lead logistics manager for the functional area in supply planning, including demand forecasting according to IOPS requirements
• Managing supply planning to ensure alignment with study plans and timelines and overall clinical development plan.
• Providing input to the development of IP-related study documents including protocols, study and pharmacy manuals
• Responsibility for working within established timelines and helping to establish those timelines
• Being responsible for setup and management of IVRS (IWRS)
• Managing IP inventory, advising team of potential shortages and making recommendations for resupply activities based on usage trends
• Being responsible for IP shipment orders according to supply plans or as requested by Clinical Trial Management team, to ensure timely shipment and delivery to investigator sites
• Working extensively with Interactive Response Technologies (IRT) such as IVRS and IWRS and supervising and managing clinical supply activities through IRT from study start-up through study closure
• Reviewing and evaluating temperature excursion data and providing assessments to supply management team regarding excursion trends in each study.
• Monitoring IP expiry data and informing Clinical Supply team and trial teams of pending IP expiry.
• Developing plans for supplying clinical study sites with ancillary supplies, either through in-house initiated supply or working with supply vendors.
• Ensuring appropriate documentation of IP supply activities is provided to clinical trial teams for the Trial Master File.
• Leading management of IP service vendors (performance, quality, timelines, results, costs)

This role might be for you have:

• Demonstrated experience in Clinical Logistics / Supply Management working with cross-functional study teams on budgets, SoWs, contracts and timelines for IP
• Provided input into IP-related content for training materials and study specific working practices, coordinated training on study procedures
• Established study team contacts, roles, responsibilities, and objectives for IP-related services
• Developed, managed and maintained relationships with external partners and acted as point of escalation for IP-related issues.

To be considered for this opportunity you must have a degree in supply chain, drug development or related field, or equivalent qualification or experience. Six years of proven experience in the biotechnology/pharmaceutical industry, with three years minimum in clinical supply management. Some line management experience preferable. 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. Computer skills, with competency in MS Word, Excel. Study Tools including electronic system skills IVRS/IWRS, CTMS, EDC. 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 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 maternity 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.

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