Senior Manager, Clinical Supply Chain (Biologics)

Oruka Therapeutics•Waltham, MA

14h•Hybrid

About The Position

Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. As we build our core team, we're seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger. Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture. 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.

Requirements

Bachelor’s or Master’s in a scientific discipline with 6+ 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

Nice To Haves

Experience with clinical supply chain involving cold chain products is a plus
Exposure to support clinical supply activities involving vials or pre-filled syringes is a plus

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