Senior Manager/Associate Director Clinical Monitoring Strategy & Optimization
Oruka TherapeuticsAbout the role
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. 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: Sr. Manager/Associate Director, Clinical Monitoring Strategy and Optimization
Location: Remote OR Hybrid 3 days/week if located near office in either Waltham, MA or Menlo Park, CA will be required.
Role Overview:
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.
Key Responsibilities:
Clinical Monitoring Leadership
- 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.
Vendor and CRO Oversight
- 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.
Trial Execution and Compliance
- 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.
Operational Process Development
- 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.
Team Leadership and Mentorship
- 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.
Qualifications:
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 glo
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