Director, Clinical Operations

Job Summary

As the leader of the cross-functional Clinical Program Team, the Clinical Program Leader will lead the planning and execution strategy of assigned clinical trials to achieve overall program and corporate objectives.  The Clinical Program Leader will be responsible for leading a team of clinical managers and clinical trial associates. The Clinical Program Leader will represent operational perspective at the cross functional Global Program Team (or similar) ensuring high quality, feasible trials are planned with clear timelines, budget and deliverables.  The Clinical Program Leader will drive operational excellence through process improvement, sharing best practices, and proactive planning.  The Clinical Program Leader is 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.  The Clinical Program Leader will have direct reports.

Primary Responsibilities

• Independently leads and manages the cross-functional Clinical Program Sub 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 program 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) 

• 10+ years of clinical operations experience with a biotech/pharmaceutical company.  Phase 1/2/3 global clinical study experience required.
• 3+ years of people management.
• Experience in rare disease
• Global study experience required.
• Understanding of FDA, EMEA, GDPR, ICH and GCP regulations and guidelines.

Preferred Skills

• Experience in pediatric neuromuscular disorders

Education Requirements

• BA/BS in a clinical or scientific discipline.