layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

LAYIQ - Senior Manager, Clinical Supply Chain – Biologics at Oruka Therapeutics

Develop and execute clinical supply strategies for multiple early- and late-stage clinical programs, including Phase 1, Phase 2, and global Phase 3 studies.
Lead clinical supply chain activities, including demand forecasting, labeling, packaging, distribution, inventory management, IRT implementation and maintenance, expiry management, returns, reconciliation, and destruction.
Develop and maintain comprehensive supply plans aligned with clinical enrollment projections, dosing requirements, protocol assumptions, regulatory timelines, and study milestones.
Author, review, and/or approve clinical label text, packaging specifications, packaging batch records, distribution documentation, pharmacy manuals, and clinical supply sections of study-related documents.
Provide clinical supply subject-matter expertise for label development, packaging design, distribution strategies, depot networks, kit configurations, and randomization and packaging requirements in accordance with applicable regulations and Good Manufacturing Practices.
Lead the selection, onboarding, and operational oversight of contract packaging organizations, clinical depots, couriers, IRT vendors, and other external supply partners.
Support site initiation visits, ongoing clinical trial activities, and open-label extension studies by ensuring the timely availability of clinical supplies, Certificates of Analysis, stability and expiry information, handling instructions, and return or destruction guidance.
Proactively identify and manage risks related to enrollment changes, protocol amendments, study timelines, supply availability, expiry, inventory levels, and distribution requirements.
Support clinical supply and logistics planning for global regulatory submissions, health authority responses, and inspection-readiness activities.
Partner with Quality and other stakeholders to facilitate the timely review, approval, and execution of standard operating procedures, batch records, lot-release documentation, change controls, deviations, investigations, and corrective and preventive actions.
Collaborate with Quality, Clinical Operations, IRT vendors, and other appropriate functions to confirm product-release status, shipment authorization, IRT configuration, and maintenance of study-blind integrity.
Identify and implement process improvements through the development of procedures, reports, templates, metrics, and scalable clinical supply practices.
Manage clinical supply budgets, contracts, purchase orders, timelines, and vendor deliverables in partnership with Finance, Procurement, and Legal, as applicable.
Serve as the person-in-plant during clinical labeling and packaging campaigns, as needed.
Travel approximately 20–25% to support vendor due diligence, business reviews, packaging campaigns, and other clinical supply activities.

Senior Manager, Clinical Supply Chain – Biologics

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