Oruka Therapeutics · 1 month ago
Senior Manager/Associate Director Clinical Monitoring Strategy & Optimization
United States
Full-time
Remote
Lead/Staff
$161K/yr - $187K/yr
6+ years expOruka Therapeutics is developing novel biologics aimed at treating chronic skin diseases. They are seeking a Senior Manager/Associate Director of Clinical Monitoring Strategy and Optimization to provide leadership for clinical monitoring activities across development programs, ensuring high-quality execution of clinical trials and oversight of CRO performance.
BiotechnologyHealthcareHealth CareMedical
Responsibilities
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
Establish effective CRO oversight and governance processes
Monitor CRO performance through KPIs, metrics, and regular operational reviews
Escalate and resolve study conduct issues proactively
Participate in vendor selection, qualification, and contract review activities
Ensure studies are conducted in compliance with ICH-GCP, SOPs, protocol requirements, and applicable regulations
Support development and review of key study documents including Monitoring Plans, Risk Management Plans, Study Oversight Plans, Clinical Trial Management Plans, and Site Management Plans
Contribute to inspection readiness activities and support regulatory inspections and audits
Help build scalable clinical monitoring infrastructure appropriate for a growing biotech company
Develop and refine SOPs, work instructions, templates, and monitoring processes
Drive continuous improvement initiatives focused on quality, efficiency, and operational excellence
Implement and optimize risk-based monitoring methodologies and centralized monitoring approaches where appropriate
May directly manage CRAs and/or Clinical Trial Managers as the organization grows
Mentor junior clinical operations staff and contribute to team development
Foster a collaborative, accountable, and quality-focused culture
Qualification
Required
Bachelor's degree in life sciences, nursing, or related discipline
6-8+ years of clinical operations experience within biotech, pharmaceutical, or CRO environments
Significant experience overseeing clinical monitoring activities in interventional clinical trials
Strong knowledge of ICH-GCP, FDA, EMA, and global regulatory requirements
Experience managing CROs and external vendors
Demonstrated ability to work effectively in a small, fast-moving biotech environment
Excellent communication, organizational, and problem-solving skills
Extensive domestic and international travel as needed (approximately 60-80%)
Preferred
Bachelor's degree or equivalent required
Advanced degree (MS, MPH, PharmD, PhD, or RN) preferred
Experience in rare disease, immunology, oncology, or other relevant therapeutic areas
Experience supporting NDA/BLA-enabling studies and regulatory inspections
Experience implementing risk-based monitoring strategies and oversight models
Prior people management experience
Benefits
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.
Competitive salary and benefits package.
A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.
Opportunities for professional growth and development.
Company
Oruka Therapeutics
Oruka Therapeutics is advancing innovative biologics to redefine patient care standards in chronic skin diseases.
11-50 employees
Funding
Current Stage
Public CompanyTotal Funding
$1.16BKey Investors
Viking Global Investors
2026-04-28Post Ipo Equity· $700.35M
2025-09-17Post Ipo Equity· $180M
2024-09-03Post Ipo Equity· $275M
Recent News
2026-05-11
Pharmaceutical Technology
2026-05-08
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