What are the responsibilities and job description for the Director, Clinical Supply Chain (Biologics) position at Tbwa Chiat/Day Inc?
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 supplies
- Manage the diligence process to select clinical and commercial clinical supply chain vendors
- Partner with operations, legal, and finance groups to finalize confidentiality, service and contractual agreements
- 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
- Lead 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 release, campaign reports, in-process sampling plans, retains, change controls, deviations, OOS / OOT investigations, and CAPAs
- Build strong relationships and partners with other leaders across CMC, quality, clinical operations, regulatory, and external CDMO / CPOs
- Conduct gap analysis, provide solutions, and ensure consistent improvements across relevant supply chain activities / deliverables
- Serve as person-in-plant (PIP) during label and packaging campaigns
- 20-25% travel in support of diligence and campaign execution at the CPOs
Qualifications :
Compensation :
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 :
Apply for this job
Please submit your application through our website.
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Salary : $200,000 - $225,000
