Director – Clinical Monitoring Strategy

Oruka Therapeutics

Director of Clinical Monitoring Strategy and Optimization leading clinical monitoring activities at Oruka Therapeutics. Overseeing CRO performance and ensuring high-quality execution of clinical trials.

Posted 5/29/2026full-timeMenlo Park • California, Massachusetts • 🇺🇸 United StatesLead💰 $213,000 - $240,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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 all vendors involved with clinical monitoring to ensure quality, timelines, and budget adherence.
Develop metrics to oversee monitoring progress including central monitoring performance and protocol deviation management.
Drive the development of the clinical monitoring plan, annotated monitoring visit reports and all training materials for CRAs.
Identify Key Risk indicators for studies at the investigative site level and their associated oversight.
Contribute to inspection readiness activities and support regulatory inspections and audits.
Participate in or lead Site Qualification or Initiation visits as needed to build site relationships and monitor CRA performance.
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.

Requirements

What you’ll need

Bachelor’s degree in life sciences, nursing, or related discipline.
10+ years (Director) of clinical operations experience within biotech, pharmaceutical, or CRO environments.
Significant experience overseeing clinical monitoring activities in interventional clinical trials.
Capable of presenting and training audiences of varied backgrounds, including PIs, Sub-Is, Study Coordinators and other site staff.
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%).

Benefits

Comp & perks

A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
Competitive salary and benefits package.
A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.
Opportunities for professional growth and development.

ATS Keywords

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Hard Skills & Tools

clinical monitoringrisk-based monitoringclinical trial managementprotocol deviation managementSOP developmentmetrics developmentinspection readinessinterventional clinical trialsvendor managementcentralized monitoring

Soft Skills

leadershipcommunicationorganizational skillsproblem-solvingmentoringcollaborationaccountabilitytrainingteam developmentcontinuous improvement

Certifications

Bachelor’s degree in life sciencesBachelor’s degree in nursing