About the job
About Us:
Oruka Therapeutics (Nasdaq: ORKA) is pioneering innovative biologics aimed at redefining the treatment landscape for chronic skin conditions. Our mission is to empower individuals battling chronic skin diseases, such as plaque psoriasis, by providing them with unprecedented freedom from their ailments through infrequent dosing, potentially as little as once or twice a year. With a robust pipeline of cutting-edge antibodies developed by Paragon Therapeutics, we target fundamental mechanisms associated with plaque psoriasis and various dermatologic and inflammatory disorders. For further insights, visit www.orukatx.com.
As we expand our core team, we are in pursuit of exceptional talent across diverse functional areas. We seek individuals who are not only interested in a job but are excited about being part of a transformative journey. If you are passionate about making a significant impact and are eager to foster a collaborative, inclusive, and positive workplace culture, we invite you to join us.
Job Title: Associate Director / Director of Device Development (Prefilled Syringes & Auto-Injectors)
Location: Hybrid – Waltham, MA. Candidates will be required to be in-office 3 days/week. Remote may be considered.
Position Summary
We are looking for a seasoned and motivated Associate Director or Director of Device Development to spearhead the comprehensive development of drug delivery systems, particularly focusing on prefilled syringes and auto-injectors for advanced-stage programs and commercialization.
This pivotal role includes the integration of medical device engineering, human-centered design, and human factors engineering into the development of combination products, ensuring the creation of safe, effective, and user-friendly delivery systems. The ideal candidate will possess extensive expertise in biomedical engineering, device development, and the regulatory landscape surrounding combination products, coupled with a proven track record of guiding projects from clinical phases to commercial success.
Key Responsibilities
Device & Combination Product Development
- Lead the development of prefilled syringes, auto-injectors, and associated delivery systems from late-stage clinical development through to commercialization.
- Define and implement device development strategies encompassing design, verification, validation, and lifecycle management.
- Oversee combination product development initiatives, ensuring alignment with product goals and regulatory standards.
