Senior Director, Inspection Readiness

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide leadership at the Sponsor level for ensuring inspection readiness and adherence to Good Clinical Practice (GCP) across clinical studies, programs, and functional areas.

• Develop, implement, and sustain a risk-based framework for inspection readiness.

• Evaluate the readiness of clinical studies and operational processes, focusing on documentation, Sponsor oversight, issue management, data integrity, and regulatory compliance.

• Identify gaps in compliance, processes, documentation, and oversight, and drive corrective and preventive actions.

• Oversee the requirements for clinical trial registration and results reporting, including those mandated by ClinicalTrials.gov.

• Monitor reporting requirements, accountabilities, timelines, supporting documentation, and evidence of compliance.

• Assess training needs and develop training matrices for clinical development.

• Review and enhance Standard Operating Procedures (SOPs), work instructions, plans, templates, and controlled documents.

• Support the development, implementation, training, and adoption of new or revised processes.

• Collaborate with Data Management/Biometrics and cross-functional teams to ensure operational quality, data integrity, issue resolution, and readiness for database lock.

• Ensure Trial Master Files and essential records are inspection-ready.

• Evaluate practices and documentation for oversight of Contract Research Organizations (CROs) and vendors.

• Establish metrics, dashboards, risk indicators, and management routines for inspection readiness.

• Lead or coordinate mock inspections, gap assessments, and focused deep dives.

• Assist with regulatory inspections and Sponsor audits, including planning, document preparation, interview preparation, response coordination, and remediation.

• Collaborate with Quality to ensure Clinical Operations are aligned with the Quality Management System.

• Stay informed about evolving ICH-GCP expectations, regulations, inspection trends, and industry best practices.

• Foster quality, accountability, operational discipline, continuous improvement, and proactive inspection readiness.

• Provide senior-level coaching and guidance on GCP compliance, inspection readiness, documentation, and operational excellence.

• Support strategic initiatives within Global Clinical Operations and the wider development organization.

• Travel domestically and internationally as required, up to 20–30% of the time.

⛳️ Requirements

• Bachelor's degree in life sciences or a related field.

• Over 15 years of experience in clinical operations, clinical quality, or related drug development roles.

• Extensive direct experience in executing global clinical trials and ensuring inspection readiness.

• Comprehensive knowledge of ICH-GCP, Sponsor responsibilities, relevant clinical trial regulations, quality systems, and regulatory inspection expectations.

• Proven experience in preparing for and supporting regulatory inspections, Sponsor audits, mock inspections, and assessments of inspection readiness.

• Strong understanding of the complete cycle of clinical trial operations, including study start-up, conduct, monitoring, data management, safety interfaces, TMF, CRO/vendor oversight, database lock, closeout, and reporting.

• Familiarity with clinical trial registration and results disclosure requirements, particularly those related to ClinicalTrials.gov.

• Experience in reviewing, developing, or improving SOPs, work instructions, controlled documents, training requirements, and operational processes.

• Background in assessing and addressing cross-functional compliance and operational gaps.

• Solid knowledge of TMF requirements and practices for inspection-ready documentation.

• Experience in collaborating with Data Management/Biometrics, Regulatory, Quality, Clinical Development, Safety, and other functions.

• Strong oversight experience with CROs and vendors.

• Ability to thrive in a small, fast-paced, growth-focused biotechnology or pharmaceutical environment.

• Excellent cross-functional leadership skills with the capability to influence senior stakeholders and drive accountability without direct authority.

• Exceptional written and verbal communication skills, executive presence, sound judgment, and the ability to convey complex compliance and operational issues clearly and effectively.

• Highly analytical, detail-oriented, and process-driven, with strong project management, problem-solving, prioritization, and follow-through skills.

• Legal authorization to work in the United States.

🏝️ Benefits

• Medical insurance.

• Dental insurance.

• Paid time off.

• 401(k) with a generous company match.

• Equity.

• Bonus.