Director, Clinical Compliance

Role Overview

• Serve as a trusted GCP compliance advisor to all functions within study teams by promoting a culture of quality and helping teams integrate compliant practices into daily study execution and decision-making
• Analyze compliance metrics, audit findings, monitoring data, and operational trends across programs to identify systemic risks and opportunities for process improvement
• Apply risk-based judgment in interpreting and implementing GCP requirements, balancing regulatory expectations with operational realities to ensure compliance approaches are practical, defensible, and appropriate to the level of risk
• Drive initiatives to ensure continuous inspection readiness across clinical studies
• Assist in preparation for regulatory inspections and internal audits including readiness assessments and document reviews
• Support development of inspection storyboards and response strategies when needed
• Ensure study teams maintain inspection-ready documentation and evidence of ongoing compliance
• Support oversight of CROs and other clinical vendors to ensure compliance with contractual and regulatory expectations
• Partner with Development Outsourcing on defining and tracking vendor performance metrics and KPIs
• Participate in vendor governance meetings and performance reviews
• Identify trends or risks in vendor performance and recommend mitigation strategies
• Review and track vendor QEs
• Develop processes for oversight of monitoring activities conducted by CROs
• Review monitoring oversight plans, reports, and monitoring metrics
• Assess monitoring quality and compliance with monitoring plans
• Identify monitoring gaps and collaborate with study teams to address them
• Support identification and management of investigator or site non-compliance
• Assist study teams in evaluating protocol deviations and escalation needs
• Help develop remediation strategies for significant compliance issues
• Support study teams in identifying and appropriately escalating significant compliance issues, protocol deviations, and site noncompliance, ensuring issues are investigated, documented, and resolved in accordance with regulatory expectations
• Drive and support development and implementation of CAPAs from audits, inspections, or compliance reviews
• Track CAPA effectiveness and ensure timely closure
• Identify recurring issues and support continuous improvement initiatives
• Partner with QA to support internal and external GCP audits
• Assist with audit preparation and documentation review
• Support study teams in addressing audit findings
• Provide training to clinical teams on ICH-GCP, regulatory requirements, and internal SOPs
• Identify knowledge gaps and support development of compliance training programs
• Contribute to SOPs, guidance documents, and best practice materials.

Requirements

• Bachelors + 15 years or Masters + 12 years or PhD + 8 years of related experience with 10+ years of relevant experience in biotech/pharma or CRO roles in Clinical Operations and/or Clinical Quality Assurance (GCP)
• Excellent communication, organizational, negotiation, and interpersonal skills with a strong reputation for collaboration
• Experience managing, coaching, and mentoring personnel
• Experience supporting global clinical trials in sponsor or CRO environments
• Strong working knowledge of ICH-GCP and global regulatory requirements
• Experience supporting GCP audits or regulatory inspections
• Experience with vendor oversight and CRO management
• Experience developing or implementing CAPAs.

Tech Stack

• Google Cloud Platform