Senior Manager, Clinical Drug Supply and Logistics

Location
Tarrytown, New York, United States of America
Posted
May 22, 2021
Ref
24843BR
Required Education
Bachelors Degree
Position Type
Full time
The Senior Manager, Clinical Drug Supply & Logistics 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
• Crafting a strategy for comparator supply (forecasting, sourcing, procurement, packaging, and distribution)
• Leading 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)
• Handling 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 advising 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 if:
You have demonstrated experience in Clinical Logistics / Supply Management working with cross-functional study teams on budgets, SoWs, contracts and timelines for IP
You can provide input into IP-related content for training materials and study specific working practices, coordinated training on study procedures
You are experienced in developing trial drug supply plans and have established study team contacts, roles, responsibilities, and objectives for IP-related services
You are adept at developing and maintaining relationships with external partners and acted as point of escalation for IP-related issues.
You have working knowledge of the clinical drug development process and clinical trial methodology and knowledge of ICH/GCP and regulatory guidelines/directives.
You are comfortable working in a matrixed environment
You have cross-functional and cross-cultural awareness
You have confirmed experience developing trial drug supply plan

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

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.