Lead and oversee clinical monitoring activities for Phase 1–3 clinical trials conducted globally and/or domestically.
Serve as the internal expert for monitoring strategy, site management, and risk-based monitoring approaches.
Provide oversight and management of CROs, CRAs, and other external vendors to ensure quality, timelines, and budget adherence.
Review monitoring plans, trip reports, metrics, and monitoring deliverables for quality and compliance.
Partner cross-functionally with Clinical Development, Clinical Science, Data Management, Biostatistics, Medical Writing, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.
Ensure studies are conducted in compliance with ICH-GCP, SOPs, protocol requirements, and applicable regulations.
Develop and refine SOPs, work instructions, templates, and monitoring processes.
Support inspection readiness activities and regulatory inspections.
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About Oruka Therapeutics
Oruka Therapeutics is pioneering innovative biologics to redefine patient care standards in chronic skin diseases. We are advancing two proprietary antibody candidates, ORKA-001 and ORKA-002. These biologics aim to provide complete disease clearance for conditions like plaque psoriasis, with dosing as infrequently as once or twice per year. Our recent upsized public offering of $700 million fuels our mission to bring these life-changing treatments to patients.
How We Work
We foster a vibrant startup culture, building our core team with individuals passionate about making a difference. Our environment is supportive and inclusive, encouraging everyone to bring their authentic selves to work. We embrace remote work flexibility; while some roles are fully remote, others offer a hybrid model requiring three days a week in our Waltham, MA or Menlo Park, CA offices if you're within commutable distance. You will contribute to establishing an engaged and positive company culture, directly impacting patient care.
Engineering at Oruka Therapeutics
Our scientific approach centers on developing novel biologics, specifically monoclonal antibodies engineered for extended circulation. This allows for significantly reduced dosing frequency for patients with chronic skin diseases. You will work with technologies like Phoenix WinNonlin/NLME, R, and NONMEM to analyze complex PK/PD data. Your efforts will drive pharmacokinetic modeling, supporting rapid development and best-in-class treatments.
Why Join Us
Directly impact patients by bringing new medicines for chronic skin diseases to market.
Join a vibrant startup with a mission to redefine patient care standards.
Work in a supportive, inclusive team environment that values your authentic self.
Gain opportunities for professional growth and continuous development.
Contribute to a company with significant funding and a strong pipeline of innovative biologics.
Benefits & Perks
Competitive salary and equity opportunities.
Performance-related bonus potential.
Comprehensive health benefits (medical, dental, vision).
Wellness and retirement benefits.
Flexible time off policy.
Holiday policy including one-week company-wide shutdowns each year.