Director, Clinical Monitoring Strategy

Job Title:            Director, Clinical Monitoring Strategy and Optimization

Location:  Remote or Waltham, MA or Menlo Park, CA,  Hybrid – onsite up to 3 days/week is required when not traveling.

Role Overview:

We are seeking an experienced and highly motivated 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.

This role will involve extensive regional and national/international travel (up to 80%) to clinical sites and vendors as needed to support training, study visits, oversight of staff and relationship building.

Key Responsibilities:

 Clinical Monitoring Leadership and Oversight

•  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.

Trial Execution and Compliance

•  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.

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.
• 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%).

Preferred

• Bachelor’s degree or equivalent required.
• Advanced degree (MS, MPH, PharmD, PhD, or RN) preferred.
• Experience in immunology, dermatology, rheumatology, or oncology.
• Experience supporting NDA/BLA-enabling studies and regulatory inspections.
• Experience implementing risk-based monitoring strategies and oversight models.
• Prior people management experience.
• Strategic thinker with strong execution skills
• Comfortable with ambiguity and rapid change
• Hands-on and solutions-oriented
• Strong collaborator and relationship builder
• High attention to detail and commitment to quality
• Ability to influence cross-functional teams and external partners

Compensation:

• 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.
• The anticipated salary range for candidates is $213,000 - $240,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. 

Location:  Remote or Waltham, MA or Menlo Park, CA,  Hybrid – onsite up to 3 days/week is required when not traveling.