Executive Director, Clinical Operations

Artemis-Executive Search; San Francisco (CA); On-site; USD 250,000 - 380,000; Full time

Job summary

The Executive Director, Clinical Operations is a strategic leader responsible for establishing and overseeing an integrated framework that ensures compliant, efficient, and high-quality execution of clinical trials across the development portfolio.

This role provides enterprise leadership for Clinical Operations Compliance, Patient Recruitment and Retention Strategy, Data Privacy, Disclosure Management, and Informed Consent Governance while driving consistency in operational processes, risk

Qualifications

• Bachelor’s degree in related discipline with significant experience in clinical operations
• Master’s degree in a related discipline with substantial leadership experience
• Doctoral degree in related discipline with extensive related experience
• Equivalent combination of education and experience

Responsibilities

• Provide strategic leadership and oversight for the Clinical Operations Compliance and Portfolio Support function.
• Establish and maintain an integrated portfolio governance framework encompassing compliance, quality, risk management, patient recruitment and retention, informed consent, data privacy, and disclosure activities.
• Lead enterprise-wide risk and issue management processes and ensure appropriate escalation, governance, and resolution of critical operational and quality issues.
• Drive cross-study and cross-functional consistency in clinical trial execution, operational processes, templates, systems, and procedures.
• Oversee inspection readiness strategy and activities across the clinical development portfolio in partnership with Quality Assurance and development functions.
• Lead CAPA governance, monitoring, and reporting activities and provide executive-level updates regarding compliance trends, risks, and remediation progress.
• Partner with Quality Assurance, Legal, Regulatory Affairs, and Privacy functions to ensure compliance with global regulatory requirements, privacy regulations, and evolving industry expectations.

Education

Bachelor’s degree in related discipline

Master’s degree in related discipline

Doctoral degree in related discipline

Job description

The Executive Director, Clinical Operations is a strategic leader responsible for establishing and overseeing an integrated framework that ensures compliant, efficient, and high-quality execution of clinical trials across the development portfolio. This role provides enterprise leadership for Clinical Operations Compliance, Patient Recruitment and Retention Strategy, Data Privacy, Disclosure Management, and Informed Consent Governance while driving consistency in operational processes, risk management, quality oversight, and inspection readiness across all clinical programs.Tips: Provide a summary of the role, what success in the position looks like, and how this role fits into the organization overall.

Responsibilities

Provide strategic leadership and oversight for the Clinical Operations Compliance and Portfolio Support function.

Establish and maintain an integrated portfolio governance framework encompassing compliance, quality, risk management, patient recruitment and retention, informed consent, data privacy, and disclosure activities.

Lead enterprise-wide risk and issue management processes and ensure appropriate escalation, governance, and resolution of critical operational and quality issues.

Drive cross-study and cross-functional consistency in clinical trial execution, operational processes, templates, systems, and procedures.

Oversee inspection readiness strategy and activities across the clinical development portfolio in partnership with Quality Assurance and development functions.

Lead CAPA governance, monitoring, and reporting activities and provide executive-level updates regarding compliance trends, risks, and remediation progress.

Partner with Quality Assurance, Legal, Regulatory Affairs, and Privacy functions to ensure compliance with global regulatory requirements, privacy regulations, and evolving industry expectations.

Qualifications

• Bachelor’s degree in related discipline and a minimum of 18 years of related experience; or,
• Master’s degree in related discipline and a minimum of 16 years of related experience; or,
• Doctoral degree in related discipline and a minimum of 15 years of related experience; or,

Equivalent combination of education and experience