Senior Manager/Associate Director Clinical Monitoring Strategy & Optimization
About The Position
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. 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. We are seeking an experienced and highly motivated Sr. Manager/Associate Director of Clinical Monitoring Strategy and Optimization to provide strategic and operational leadership for clinical monitoring activities across our development programs. This individual will play a critical role in building and scaling clinical operations infrastructure within a fast-paced emerging biotech environment. The successful candidate will oversee CRO monitoring performance, ensure high-quality execution of clinical trials, and contribute to the development of monitoring processes, vendor oversight strategies, and inspection readiness activities. This role requires a hands-on leader who is comfortable operating both strategically and tactically in a lean organization.
Requirements
- 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%).
Nice To Haves
- 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.
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.
Benefits
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
