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Oruka Therapeutics · 5 months ago

Associate Director, Clinical Supply Chain (Biologics)

Waltham, MA

Full-time

Hybrid

Lead/Staff, Director/Executive

$175K/yr - $200K/yr

8+ years exp

Oruka Therapeutics is developing novel biologics aimed at treating chronic skin diseases. The Associate Director of Clinical Supply Chain will oversee clinical supply chain activities for clinical trials, ensuring compliance and efficiency while collaborating with various stakeholders.

BiotechnologyHealth CareMedical

Responsibilities

Execute clinical supply chain activities including but not limited to labeling, packaging, distribution, inventory management, forecasting, IRT initiation, maintenance and expiry of clinical supplies

Author, review and/or approve clinical labels, packaging batch records, shipping documents, stability, clinical study, and pharmacy protocols

Serve as subject matter expert to generate label texts, distribution lanes, randomization codes, packaging specifications, and designs in compliance with regulations and GMPs

Support site initiation visits (SIV), trials and OLEs by providing timely delivery of supplies, CoAs, stability, expiration, handling and destruction information

Plan and adapt to changes against clinical demands, trial and protocol changes, expiration, and inventory management

Support clinical supply and logistics planning in support of global regulatory filings

Liaise with stakeholders to support timely approval and execution of SOPs, batch records, lot releases, change controls, deviations, and CAPAs

Support clinical distribution across US, Canada and EU through both IRT and manual driven site shipments and depot transfers

Verify with Quality the accuracy within blinded studies' drug release, shipments & IRT setup

Identify and execute process improvements through report development and SOPs

Build strong relationships and partners with other leaders across CMC, quality, clinical operations, regulatory, and external CDMO/CPOs

Serve as person-in-plant (PIP) during label and packaging campaigns

20-25% travel in support of diligence and campaign execution at the CPOs

Qualification

Clinical supply chain managementLabelingPackagingInventory managementCold chain productsImport/export managementRegulatory compliancePeople managementCommunication skillsOrganizational skillsCreative problem-solving

Required

Bachelor's or Master's in a scientific discipline with 8+ years of relevant experience in clinical supply chain and logistics

Must have hands-on experience managing supply chain activities including but not limited to labeling, packaging, distribution, inventory management, forecasting, IRT initiation, maintenance and expiry of clinical supplies

Demonstrated experience managing import/export for clinical studies in US, Canada and EU

Strong clinical supply skills with operational experience in tracking multiple activities, deliverables, timelines, contracts and budgets

In-depth knowledge of quality and regulatory aspects of clinical supply chain in support of simple to complicated multi country clinical studies

Demonstrated track record of successful tech transfers to commercial CPOs with an eye towards late stage and commercial launch

Excellent writing, organization, communication and people management skills with the ability to work effectively with a diverse group of internal and external stakeholders

Must have a creative, organized and strategic attitude with the ability to work in a fast-paced environment