Manager, Clinical Drug Supply & Logistics

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary:
The Clinical Drug Supply & Logistics Manager (CLM) role is a key leadership role within Global Clinical Operations. The role holder will manage the supply chain for a portfolio of global clinical studies across all phases within a drug development program. He / she will lead cross-functional Drug Resource Utilization Group (DRUG) and represent this and other teams on the Clinical Study Team. The CLM works in collaboration with customer functions to influence and manage demand for individual studies, and is responsible for their supply chain deliverables through leadership of the DRUG.

Responsibilities:
In general, the Clinical Logistics Manager will:

• Understand and translate clinical study protocol requirements into demand for drug product within a clinical study including requirements for placebo, comparators and rescue / challenge medication.

• Use simulation tools and supply chain expertise to design optimised, lean supply chains for individual studies, defining allocation of contingency stock, IRT parameters and requirements of drug product. Where possible seek innovative flexible supply chain solutions capable of supporting multiple studies.

• Author the drug supply section of Clinical Study Protocol.

• Assist in development of master label text.

• Develop options for how the supply requirements of individual/groups of clinical studies can be delivered and propose to the IOPS Supply Chain Team. This will include sourcing and alignment of sourcing activities with customers, detailed plans including timing of investments/cost expenditure (e.g. purchase of comparator product, phased spend at CMOs), identification and management of risks.

• Establish the cost strategies and cost plan for the individual study. Ensure optimal spend forecast for comparators and distribution cost.

• Collaborate with Clinical & IOPS in development of pack design.

• Ensure input into the design of the random scheme, incl. pack lists and timely provision of these to CMO and IRT vendor.

• Define IRT user requirements, set up IRT tool and ensure timely go-live for individual studies.

• Establish and lead risk management of individual studies during the planning phase, with proactive mitigation of risks threatening quality or delivery of supplies. Escalate significant issues to SCT as appropriate.

• Is the primary contact for Study Management with Global Clinical Operations.

• Provides active management of the clinical supply to a number of studies, is skilled in providing routine and independent problem solving, and fast and effective solutions for day to day maintenance of studies. Ensures team delivers clinical supplies effectively and consistently, balancing cost and risk to supply.

• Leads and provides direction to Drug Resource Utilization Group (DRUG) comprising members of IOPS SC, Global Clinical Operations and Project Management.

• Ensures effective communication within CLO and with customers and CLO partners.

• Lead risk management of individual studies during execution, with proactive mitigation of risks threatening quality or delivery of supplies. Escalate significant issues to SCT as appropriate.

• Use IRT to track recruitment and adjust IRT parameters to accommodate any changes in study scope and design.

• Degree in supply chain related or drug development discipline or equivalent qualification or experience.

• Significant experience managing and influencing customer demands.

• Working knowledge of the Clinical Trial Directive and global regulatory environment impacting the provision of investigational products. In depth knowledge of R&D supply chain and drug development process.

• In depth knowledge of Clinical Development processes relevant to the supply of clinical materials.

• Experience of project management.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
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