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Job Summary 

As Head of Clinical Operations, you will lead the planning and execution strategy of assigned clinical trials to achieve overall program and corporate objectives.  You will be responsible for leading a team of clinical managers and clinical trial associates. This person will ensure high quality, feasible trials are planned with clear timelines, within budget and deliverables.  They will drive operational excellence through process improvement, sharing best practices, and proactive planning.  The Head of Clinical Operations will be the primary point of escalation for resolution of trial management operational issues.  This role will interact with the executive committee and is expected to present at development committee meetings and will have direct reports.

Primary Responsibilities 

• Independently Leads and manages the cross-functional clinical operations team to ensure deliverables are met within the established timelines, budget and quality/compliance standards. 
• Represents clinical operations at external and internal meetings related to assigned clinical program topics.
• Determines the clinical vendor strategy for assigned studies/program; participates in the evaluation and selection of vendors, develops scope of work.
• Oversees and manages Clinical Project Managers, Clinical Trial Associates, or other assigned clinical trial support associates.
• Serves as escalation point for clinical vendors and is a member of the JOC.
• Represents clinical programs at internal governance meetings.
• Contributes to the development of clinical trial documents by providing executional input to ensure efficient, high quality, executable clinical protocols are approved.
• Responsible to ensure clinical trial protocol(s) go through all internal review and approval processes.
• Guides clinical project managers in the need for trial related materials and initiate the development of scientific trial related documents (e.g. charters, scientific training material, recruitment materials) with the CTT.
• Contribute to the safety and data review plans for studies.
• Organize and participate in trial advisory committees (e.g. Safety Review Committees, Data Monitoring Committee, Steering Committee).
• Actively contribute to feasibility exercises and site/country selection.
• Guides team in managing study risks through risk mitigation planning, proactive team communication and creative problem solving.
• Ensure Good Clinical Practice and inspection readiness across studies including complete documentation and trial master file throughout a study.
• Develop and oversee implementation of corrective actions to support good data quality.
• Study budget management including forecasting, regular review of accruals, and clinical contract management.
• Oversees immediate team to develop new methods and solutions to overcome hurdles within clinical operations and other functions.
• Identifies areas for new/refined processes within and outside of clinical operations.
• Initiates projects that help to create and refine the clinical operations organization.

Core Competencies (Required Skills)  

• Phase 1/2/3 global clinical study experience required.
• Rare disease experience.
• Global study experience required.
• Understanding of FDA, EMEA, GDPR, ICH and GCP regulations and guidelines.

Preferred Skills 

• Experience in pediatric neuromuscular disorders.

Education Requirements 

• Bachelor’s Degree, Life Sciences preferred. Advanced degree highly desirable.
• 15+ years’ experience in the pharmaceutical industry and/or clinical research organization, including 12+ years clinical study/program management, including at least 6 years of line management experience.