Associate Director Clinical Supply Operations

Overview

The Associate Director of Clinical Supply Operations is responsible for driving the strategy, optimization and execution of business processes within the Clinical Supply Operations (CSO) department. This position plays a key role in translating planning excellence into operational outcomes, while leveraging data driven insights, and driving a culture of continual improvement and responsiveness. The incumbent will be responsible for ensuring strategic alignment of operational activity in the organization while providing value-added analytical insights to support the goals of the CSO team.

NOTE: This role requires 4-days onsite and is NOT eligible remote.

• Manage and oversee Clinical Logistics Vendors in the strategic and operational execution of Clinical Supply Distribution. Includes monitoring performance, driving improvements, issue resolution, and escalation management.
• Manage and oversee strategic and operational Clinical Supply Operations activities, driving standardization, analytics, and continuous improvement.
• Lead a team providing support for Global Clinical Logistics planning & execution, ensuring compliant and timely shipment and delivery between depots and investigator sites, working with our Logistics Providers.
• Ensure seamless logistical execution through global Inventory visibility including management of material movements, expiry, returns, reconciliation & destruction processes, leveraging IRT and related systems and processes.
• Ensure appropriate visibility to priorities for optimization of QP release, Regulatory Release processes and support for Logistics Vendor and Industrial Operations activities (e.g. packaging campaign documentation), including co-ordination of expedited shipments.
• Define needs for data analytics capabilities to enable data driven insights on the worldwide clinical supply chain, collaborating with partner Clinical Drug Supply & Logistics Teams and the wider Regeneron Supply Organization (e.g. Industrial Operations).
• Develop reporting that drives continuous improvement against key performance measures both internally and with our logistics vendors. This will be accomplished by analyzing operational data to inform performance improvement opportunities with an emphasis on understanding key operational performance indicators and the impact they have on supply delivery.
• Create and manage reporting metrics and determine how best to provide visibility to operations performance via report creation, insights and analyzing system dashboards.
• Ensure team is in continual state of inspection readiness with robust documentation workflow and archival of documentation of IP supply activities provided to clinical trial teams for the Trial Master File.
• Lead process improvement opportunities that enable more agile operations, enhanced strategic insights, and analytical capabilities.

• This role may be for you if you have:
• Must be able to effectively communicate to all levels of the organization, including senior management.
• Experience working with and/or managing external vendors.
• Must be able to develop and present varied and unique ideas.
• Effective stakeholder management, influence and negotiation skills.
• Proven Functional and Line Management skills.
• Financial acumen in creating and managing budgets.
• Must have broad knowledge and cross-functional understanding of clinical trial methodology.
• Working knowledge of GCP and ICH Guidelines.

To be considered for this opportunity, you should have a BS/BA and at least 10+ years of relevant experience in the biotechnology/pharmaceutical industry, with 5 years line management experience.

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.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability…