Associate Director, Clinical Trial Lead

Job Title: Associate Director, Clinical Trial Lead

Work Location: Suffolk County, Massachusetts

Summary:

Seeking an experienced professional to provide strategic and operational leadership for global Phase II and III clinical trials. This role is responsible for planning, execution, and delivery of clinical studies, ensuring quality, timeliness, and budget adherence. The position requires strong cross-functional leadership, vendor oversight, and risk management skills, with a focus on late-stage clinical development.

Responsibilities:

• Lead global Phase II and III clinical trials from protocol development through study closeout, ensuring all milestones are met.
• Direct cross-functional study teams, establishing clear plans, roles, and communication pathways to drive operational excellence.
• Translate clinical program strategies into actionable study plans, including site selection, enrollment forecasting, and resource allocation.
• Oversee selection, contracting, and performance management of CROs and specialty vendors, ensuring adherence to timelines, budgets, and quality standards.
• Manage study-level risk, including identification, escalation, mitigation, and communication of operational and quality issues.
• Ensure compliance with protocols, SOPs, ICH-GCP, and regulatory requirements across all study activities and maintain inspection readiness.
• Utilize and oversee clinical systems (EDC, CTMS, IRT, eTMF) for study setup, milestone tracking, and reporting, ensuring data integrity and quality.
• Mentor and guide study team members, contribute to process improvements, and provide clear status updates to stakeholders and leadership.

Qualifications:

• Bachelor’s degree in life sciences, nursing, pharmacy, or related field; advanced degree preferred.
• 8+ years of progressive experience in clinical development or clinical operations within biotechnology, pharmaceutical, or CRO settings.
• Proven experience independently leading global, multicountry Phase II and III interventional clinical trials with direct accountability for timelines, budgets, vendors, and quality.
• Demonstrated success advancing complex global studies through major milestones such as first patient in, enrollment completion, database lock, and study closeout.
• Strong background in late-stage development, operational planning across multiple regions, and managing cross-functional dependencies.
• Extensive CRO and vendor oversight experience, including selection, contracting, governance, and performance management.
• Hands-on expertise in study-level risk management, risk-based monitoring, TMF oversight, inspection readiness, and regulatory inspections.
• Thorough knowledge of ICH-GCP, global clinical trial regulations, and clinical development processes.
• Proficiency with EDC, CTMS, IRT, and eTMF platforms (e.g., Veeva, Medidata) and ability to leverage study data for decision-making.
• Experience in clinical-stage biotechnology and in fibrotic disease, rare disease, or related therapeutic areas strongly preferred.
• Demonstrated leadership, decision-making, issue resolution, and stakeholder alignment skills.
• Excellent communication, facilitation, negotiation, financial management, and executive presentation abilities.
• Highly accountable, solutions-oriented, self-directed, and agile in managing shifting priorities and timelines.
• Strong proficiency with Microsoft Word, Excel, PowerPoint, and Outlook.

Published Category: Clinical Operations & Development