Director – Clinical Monitoring Strategy

Role Overview

• 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

• 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%).

Tech Stack

• Google Cloud Platform

Benefits

• 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.