Executive Director – Operations Lead

Manage clinical trials and programs across the product life cycle
Create, execute, and proactively manage clinical trial processes from study planning through close-out
Define tactics and manage daily operational activities to meet timelines and deliverables
Provide leadership, strategic oversight, and guidance to Clinical Operations
Establish performance indicators for successful clinical trial execution
Integrate clinical operations expertise into Clinical Development activities, development plans, and study protocols
Review CRO proposals and budgets and participate in CRO selection
Review and negotiate investigator grant budgets
Represent Clinical Operations to the Executive Committee, Project Teams, Board of Directors, and internal stakeholders
Lead, mentor, train, and support the professional development of Clinical Operations staff
Oversee quality checks and compliance with SOPs, ICH-GCP guidelines, regulations, and patient safety standards
Mentor staff on regulatory inspections and inspection readiness
Assist QA with developing, reviewing, and updating clinical SOPs
Author operational sections of protocols and investigator brochures
Identify and interact with investigative sites and investigators
Maintain relationships with CROs, external experts, and investigators
Coordinate with Biometrics on clinical data deliverables
Support regulatory submissions, dossier development, and interactions with FDA, EMA, and other agencies
Monitor competitive regulatory and clinical practices and adjust plans accordingly

• Bachelor’s in Life Sciences, Nursing Licensure, or Pharmacy
• Minimum of 10 years of experience in clinical operations development and strategic planning
• Experience developing, implementing, and leading early- to late-stage clinical trials
• In-depth understanding across the clinical operations value chain
• Track record in study planning, execution, data cleaning, database locking, study report generation, and regulatory inspection
• Relevant therapeutic area experience
• Experience with pivotal, multi-site, multinational clinical trials
• Experience with global drug development and NDA filing
• Experience developing protocols, SOPs, Clinical Study Reports, INDs, NDAs, and other clinical, regulatory, and safety documents
• Experience collaborating with cross-functional teams to meet study deliverables on time and on budget
• Advanced degree (MS or PharmD) preferred

Demonstrates expertise in managing clinical trials and programs throughout the product life cycle, with a strong focus on strategic planning, regulatory compliance, and operational excellence. Proven ability to lead cross-functional teams and mentor staff while ensuring adherence to industry standards and timelines.

• Clinical Trial Management
• Regulatory Compliance
• Strategic Planning
• Cross-Functional Collaboration
• Clinical Operations Leadership

• Clinical Trial Processes
• Study Planning
• Protocol Development
• SOP Development
• Regulatory Submissions
• Data Cleaning
• Database Locking
• Clinical Study Reports
• NDA Filing
• Investigator Grant Budgets

• Leadership
• Mentoring
• Communication
• Team Collaboration
• Problem Solving

• Nursing Licensure

• ICH-GCP Guidelines
• Clinical Operations
• Biometrics Coordination
• Therapeutic Area Experience
• Global Drug Development