Associate Director Clinical Supply Operations jobs in United States
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Regeneron · 2 days ago

Associate Director Clinical Supply Operations

Regeneron is a leading company in the Pharmaceutical/Biotech industry, seeking an Associate Director of Clinical Supply Operations. This role is responsible for driving the strategy and execution of business processes within the Clinical Supply Operations department, ensuring operational excellence and providing analytical insights to support team goals.

BiopharmaBiotechnologyPharmaceutical
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

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

Qualification

Clinical Supply OperationsData AnalyticsVendor ManagementBudget ManagementClinical Trial MethodologyGCPICH GuidelinesStakeholder ManagementInfluenceProcess ImprovementCommunication SkillsNegotiation

Required

BS/BA degree
At least 10+ years of relevant experience in the biotechnology/pharmaceutical industry
5 years line management experience
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

Benefits

Health and wellness programs (including medical, dental, vision, life, and disability insurance)
Fitness centers
401(k) company match
Family support benefits
Equity awards
Annual bonuses
Paid time off
Paid leaves (e.g., military and parental leave)

Company

Regeneron

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Regeneron Pharmaceuticals specializes in the discovery, development, and commercialization of innovative medicines.

H1B Sponsorship

Regeneron has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (157)
2024 (128)
2023 (128)
2022 (137)
2021 (104)
2020 (122)

Funding

Current Stage
Public Company
Total Funding
$15.93M
Key Investors
U.S. Department of Health & Human Services
2024-07-11Post Ipo Equity· $2.03M
2023-10-18Post Ipo Equity· $5M
2016-08-22Post Ipo Equity· $8.9M

Leadership Team

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Aris Baras
Senior Vice President, Regeneron Pharmaceuticals, General Manager, Regeneron Genetics Center
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Bari Kowal
Senior Vice President, Head Development Operations & Portfolio Management
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Company data provided by crunchbase