Director, Clinical Supply Chain (Biologics)Remote
About Us: 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. We have raised nearly $500M since inception in February 2024 from top-tier investors and our first program is expected to be in the clinic in the first quarter of 2025. For more information, visit www.orukatx.com 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.
Job Title: Director, Clinical Supply Chain (Biologics)
Location: Remote
Role Overview: We are seeking an experienced and motivated candidate to lead 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 establishing sound clinical supply chain strategies for a rapidly growing start-up and enjoy working in a fast-paced environment. This role is not only highly visible but a pivotal addition to our growing organization where you will play an integral role in supporting multiple clinical trials across US, Canada and EU. You will have the opportunity to lead and support global clinical supply chain activities in support of pre-filled syringes and auto-injectors.
Lead clinical supply chain activities including but not limited to labeling, packaging, distribution, inventory management, forecasting, IRT initiation, maintenance and expiry of clinical suppliesManage the diligence process to select clinical and commercial clinical supply chain vendorsPartner with operations, legal, and finance groups to finalize confidentiality, service and contractual agreementsAuthor, review and/or approve clinical labels, packaging batch records, shipping documents, stability, clinical study, and pharmacy protocolsServe as subject matter expert to generate label texts, distribution lanes, randomization codes, packaging specifications, and designs in compliance with regulations and GMPsSupport site initiation visits (SIV), trials and OLEs by providing timely delivery of supplies, CoAs, stability, expiration, handling and destruction informationPlan and adapt to changes against clinical demands, trial and protocol changes, expiration, and inventory managementLead clinical supply and logistics planning in support of global regulatory filingsLiaise with stakeholders to support timely approval and execution of SOPs, batch records, lot release, campaign reports, in-process sampling plans, retains, change controls, deviations, OOS/OOT investigations, and CAPAsBuild strong relationships and partners with other leaders across CMC, quality, clinical operations, regulatory, and external CDMO/CPOsConduct gap analysis, provide solutions, and ensure consistent improvements across relevant supply chain activities/deliverablesServe as person-in-plant (PIP) during label and packaging campaigns20-25% travel in support of diligence and campaign execution at the CPOsQualifications: Bachelor's or Master's in a scientific discipline with 10+ years of relevant experience in clinical supply chain and logisticsMust 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 suppliesExperience with clinical supply chain involving cold chain products is a mustExposure to supporting clinical supply activities in support of pre-filled syringes and auto-injectors is a plusSignificant experience developing and executing clinical supply strategies towards early to late-stage assetsDemonstrated experience managing import/export for clinical studies in US, Canada and EUStrong clinical supply skills with operational experience in tracking multiple activities, deliverables, timelines, contracts and budgetsIn-depth knowledge of quality and regulatory aspects of clinical supply chain in support of simple to complicated multi country clinical studiesDemonstrated track record of successful tech transfers to commercial CPOs with an eye towards late stage and commercial launchExcellent writing, organization, communication and people management skills with the ability to work effectively with a diverse group of internal and external stakeholdersMust have a creative and strategic attitude with the ability to work in a fast-paced environmentCompensation: An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.The anticipated salary range for candidates is $200,000-225,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.Job Location: Remote OR position may be hybrid, based in Waltham, MA or Menlo Park, CA. Candidates will be required to be in-office in Waltham or Menlo Park 3 days/week.
We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.
What We Offer: A chance to be part of a vibrant small-company culture where your work can directly impact bringing new medicines to patients.Competitive salary and benefits package.Opportunities for professional growth and development.Apply for this jobPlease submit your application through our website.
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