Director, Clinical Compliance

This is a fully remote position, open to applicants in California, +1 more state.

📋 Description

• Act as a reliable GCP compliance consultant for all roles within study teams by fostering a culture of quality and assisting teams in incorporating compliant practices into their daily study executions and decision-making processes.

• Evaluate compliance metrics, audit results, monitoring data, and operational trends across programs to pinpoint systemic risks and opportunities for enhancing processes.

• Utilize risk-based judgment in interpreting and executing GCP requirements, balancing regulatory expectations with operational realities to ensure that compliance strategies are practical, defensible, and suitable for the associated level of risk.

• Lead initiatives to guarantee ongoing inspection readiness throughout clinical studies.

• Aid in the preparation for regulatory inspections and internal audits, including conducting readiness assessments and reviewing documentation.

• Assist in the creation of inspection storyboards and response strategies when necessary.

• Ensure that study teams maintain documentation and evidence that are ready for inspection and demonstrate ongoing compliance.

• Oversee CROs and other clinical vendors to ensure adherence to contractual and regulatory expectations.

• Collaborate with Development Outsourcing to define and monitor vendor performance metrics and KPIs.

• Engage in vendor governance meetings and performance evaluations.

• Identify trends or risks in vendor performance and propose mitigation strategies.

• Review and monitor vendor Quality Events (QEs).

• Create procedures for overseeing monitoring activities conducted by CROs.

• Review monitoring oversight plans, reports, and metrics.

• Evaluate monitoring quality and compliance with established monitoring plans.

• Identify gaps in monitoring and collaborate with study teams to address these issues.

• Assist in identifying and managing instances of investigator or site non-compliance.

• Help study teams assess protocol deviations and determine escalation requirements.

• Contribute to the development of remediation strategies for significant compliance concerns.

• Support study teams in recognizing and properly escalating major compliance issues, protocol deviations, and site non-compliance, ensuring that issues are investigated, documented, and resolved in accordance with regulatory standards.

• Facilitate the development and implementation of CAPAs resulting from audits, inspections, or compliance reviews.

• Monitor the effectiveness of CAPAs and ensure their timely closure.

• Identify recurring issues and aid in continuous improvement initiatives.

• Partner with QA to support both internal and external GCP audits.

• Assist with audit preparation and the review of documentation.

• Help study teams in addressing findings from audits.

• Provide training for clinical teams on ICH-GCP, regulatory requirements, and internal SOPs.

• Identify knowledge deficits and assist in the creation of compliance training programs.

• Contribute to the development of SOPs, guidance documents, and best practice materials.

⛳️ Requirements

• Bachelor's degree with 15 years of relevant experience, or a Master's degree with 12 years, or a PhD with 8 years of related experience, including over 10 years in biotech/pharma or CRO roles within Clinical Operations and/or Clinical Quality Assurance (GCP).

• Exceptional communication, organizational, negotiation, and interpersonal skills, with a well-established reputation for collaboration.

• Proven experience in managing, coaching, and mentoring staff.

• Experience in supporting global clinical trials in sponsor or CRO settings.

• Strong working knowledge of ICH-GCP and global regulatory requirements.

• Familiarity with GCP audits and regulatory inspections.

• Experience in vendor oversight and CRO management.

• Background in developing or implementing CAPAs.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance plans.

• Generous paid time off and holiday leave.

• Opportunities for professional development and continuing education.

• Collaborative and inclusive work environment.