The Head of Clinical Operations is responsible for overall management of the Clinical Operations function which includes clinical program management and clinical supply. S/he will be responsible for leading the Clinical Operations function to advance our gene therapy portfolio across a wide range of genetic disorders. S/he will assume responsibility for both the strategic and tactical execution of global clinical trials across all stages of development, including selecting and managing external service providers, and ensuring rigorous quality in trial conduct. S/he will be a senior leader capable of providing strategic oversight of global product development plans and study protocols and driving the successful execution of all operational components of global clinical programs using strong project management, leadership, organizational, and communication skills.

S/he will drive strong collaboration across the entire clinical organization with a strong focus on operational execution of clinical strategies including designing, planning and implementing overall direction of clinical projects from protocol development, selection and qualification of vendors/investigative sites through finalization of clinical study reports. S/he will be able to develop accrual strategies to meet enrollment goals and will participate in team efforts to complete regulatory filings to gain product approval.

S/he will be a key member of the R&D leadership team and will have the ability to develop strategy and provide oversight while remaining very hands-on, given the biotech culture.

S/he will manage the project activities including but not limited to: clinical monitoring, data management, statistical analysis, medical writing, safety monitoring, resource management, and compliance to insure proper conduct and timely completion of all projects.

The responsibilities include significant people and functional oversight including establishing functional capability needs, talent management, budgeting, goal setting and performance management.

• Accountable for operational execution across multiple clinical trials and able to address and manage risks and issues proactively
• Provide oversight and management of all clinical aspects of all clinical programs including:
  • Planning, execution and management of all aspects of multi-center global clinical trials in compliance with GCPs, SOPs, and within designated program budgets and timelines;
  • Design and development of (but not limited to) the following program-specific documentation:
    • clinical development plan
    • program timeline and budget
    • risk management plan
    • educational/training plans

• • Design and development of (but not limited to) the following study-specific strategy tools and processes:
    • investigator/site/country/patient recruitment plans
    • request for proposal [RFP] process
    • vendor specifications
    • communication plans (including site and sponsor communication as well as site escalation)
    • ongoing data review plans
    • risk management plans
    • study timeline and budget
    • educational/training plans
    • publication and congress plan
    • performance and compliance metrics

• • Development and review of (but are not limited to) the following study-specific operational forms and tools:
    • clinical protocols and amendments
    • informed consent templates
    • site feasibility questionnaires
    • case report forms [CRFs] and CRF guidelines
    • data / integrated voice recognition system [IVRS] management plans
    • Investigative site binders, pharmacy brochures, and regulatory binders
    • clinical study reports

• • Create, manage and review clinical program/study budgets and overall clinical operations budget in conjunction with Project Management and Finance;
  • Represent clinical operations for study planning and maintenance activities with external vendors, and on internal product development teams
  • Support selected investigative sites for IRB/IEC submissions, regulatory document collection and review, and budget and contract negotiations in collaboration with Legal and CROs;
  • Manage and resolve study conduct issues (including protocol deviations, data queries, SAEs/AEs, laboratory discrepancies, and archive reconciliation activities) as applicable;
  • Provide oversight and participate in study-specific meetings (e.g., Study Management Team [SMT], investigator meetings, advisory committee, etc);
  • Provide study-specific training and leadership to internal staff, CRO, sites, and other contract personnel;
  • Prepare and present program debriefings, internally and externally, as required.

• Clinical Operations Functional Activities:
  • Provide oversight and management for all clinical study activities, including clinical budgets; develop contingency plans for clinical trials
  • Provide input to Clinical project teams as needed
  • Support development of Clinical function: identify, implement, and manage departmental processes and systems (e.g., eTMF, vendor selection, SOPs, etc.)
  • Evaluate and select personnel; manage staffing needs to ensure the efficient operation of the function. Effectively mentor departmental personnel and support professional development
  • Assist in writing departmental as well as scientific technical documents

Work cross-functionally to develop and implement strategic initiatives

Participate in diligence and business development activities

Other duties or projects as assigned

• Bachelor’s degree (minimum); advanced degree in a scientific discipline, or equivalent experience strongly preferred
• Generally has 20 years of related pharmaceutical/CRO clinical operations experience in roles of increasing levels of responsibility including at least 5 years of experience leading managers.

• Experience overseeing the execution of multiple clinical trials for rare diseases with experience with biological products a plus
• Experience building clinical development organizations to support global clinical trials
• Experience designing clinical trial strategies to obtain regulatory approvalExperience working on global and complex clinical trials

• Candidates must have proven track record for delivering multi-center global clinical projects within time, budget, and quality expectations.
• Extensive knowledge of ICH-GCP and FDA regulatory requirements and competency.
• Strong clinical study design and management skills, including risk assessment and contingency planning.
• Knowledge of clinical trial systems and operational infrastructure (e.g, CTMS, Veeva)
• Capable of effectively interacting with trial sites, investigators, and external service providers