Location: Waltham, United States

Employer: Oruka Therapeutics

Role Overview: We are seeking an experienced and motivated candidate to execute clinical supply chain activities in support of early-to-late-stage clinical trials. In this role, you will be responsible for overseeing labeling, packaging, distribution, inventory management, forecasting, IRT initiation, maintenance and expiry of clinical supplies. You are an ideal candidate for this role if you enjoy working in a fast-paced, high-touch environment establishing strong relationships across CMC, Clinical, Program Management, Regulatory and Quality. You will be reporting to and working alongside the head of Clinical Supply Chain to help establish Clinical Supplies processes and best practices, while supporting multiple clinical trials across US, Canada and EU. You are highly communicative and motivated to produce results effectively, efficiently and early to support global clinical supply chain activities in support of vials and pre-filled syringes.

Key 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

How to Apply: