Associate Director, Global Clinical Supply Chain jobs in United States
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Incyte · 2 weeks ago

Associate Director, Global Clinical Supply Chain

Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines. The Associate Clinical Supply Director manages the clinical supply chain of compounds in development and drives process change within Investigational Material Supply Chain in collaboration with various internal and external stakeholders.

BiotechnologyHealth CareMedicalMedical DevicePharmaceutical
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

As a key interface and SME for IMSC Operations, drive process change and improvement initiatives with contracted CMOs, Technical Operations, Medical Affairs, Quality and Clinical Operations, etc., as needed, to ensure effectiveness and efficiency
Support training, development and mentoring indirect reports, as needed
Develop strong internal collaboration with stakeholders, such as Clinical Operations, Project Management, Regulatory, Medical Affairs, Quality and Technical Operation functions to ensure successful delivery of clinical supply
Act as a key interface between the Contract Manufacturing Organization (CMO) and clinical teams, serving as a point of escalation, for clinical supply issues, ensuring clear communication and collaboration across diverse teams
Manage all aspects of clinical study requirements and Clinical Packaging activities
In collaboration with Clinical / Technical Operations and Project management, establish and meet timelines for clinical supplies available for clinical trials, managing inventory of clinical supplies before and during clinical studies
Identify external packaging sites, monitors external clinical packaging, and reviews master batch records
Coordinate GMP auditing activities at CMOs
Provide management with accurate time frames for resolution of delays in obtaining supplies for clinical projects
Recommend insight and recommendations into procedural improvements, as needed, and assist in the implementation of the improvements
Develop and manage strategic alliances with contract partners for procurement, packaging, transportation, brokerage, storage and distribution

Qualification

Clinical supply chain managementCGMPsDrug development processUSGlobal clinical labelingAnalytical problem-solvingPlanningOrganizationTeam collaboration

Required

Degree (such as Bachelor's or Master's) in a relevant field with significant experience in managing clinical packaging, clinical inventory and distribution, or equivalent experience
Knowledge of US and Global clinical labeling, Ex-US depot and Qualified Person requirements for clinical supplies required
Ability to work both independently and collaboratively in a fast-paced, matrixed, team environment consisting of internal and external team members
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
Working knowledge of drug development process (Phase I-IV)
Working knowledge of cGMPs and familiarity with US and EU regulations
Strong analytical and problem-solving skills
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects

Company

Incyte is a drug discovery and development company which hopes to build a proprietary product pipeline of novel small molecule drugs.

H1B Sponsorship

Incyte 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 (37)
2024 (34)
2023 (32)
2022 (39)
2021 (36)
2020 (24)

Funding

Current Stage
Public Company
Total Funding
unknown
1996-01-16IPO

Leadership Team

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Bill Meury
President & CEO
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Jim Lee
Group Vice President, Head Inflammation and AutoImmunity Group
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Company data provided by crunchbase