Vice President, Head Global Clinical Operations
Editas Medicine, United States

Key Responsibilities amp; Accountabilities:

• Responsible for providing strategic, managerial and scientific oversight of all global clinical trial activities within Editas.
• Provide strong visionary leadership for all global clinical trial activities to ensure that all studies are conducted to the highest Good Clinical Practice (GCP) and quality standards, within agreed timelines and budgets.
• Develop and execute global operations strategies in close collaboration with internal stakeholders, alliance partners and Clinical Research Organizations (CROs).
• Provide leadership in collaboration with a cross-functional team to the design and implementation of Clinical Development Plans and Registrational Strategies for each product within the Editas Medicine portfolio.
• Ensure that resources, employees and expertise are appropriately prioritized to effectively and efficiently meet study timelines and budgets.
• Promote a work environment that includes coaching, mentoring, accountability, feedback and high-performance standards.
• Ensure that clinical study and operational integrity is maintained to the highest standards.
• Oversee all clinical medical writing activities including participation in protocol development, and review of investigator brochures, informed consents, and annual safety updates.
• Support and review the preparation of clinical documents for submission to global health authorities including briefing books/presentation materials supporting EMA Scientific Advice, Pre-IND, End-of-Phase II and other regulatory meetings as required.
• In alignment with quality support development of training for key clinical trial information systems to ensure compliance with study requirements and GCP, including IRB/EC instruction, industry guidelines, international standards and local and national regulations.

Requirements

Knowledge, Skills amp; Capabilities:

• Demonstrated leadership ability with experience and excellence in leading teams and driving momentum to reach goals
• Demonstrated ability to influence senior leaders and stakeholders in terms of clinical study design and development strategy
• Ability to successfully complete clinical trials in all phases and multiple therapeutic areas as well as extensive CRO oversight
• Ability to provide motivational leadership to the organization and improve its performance through the adoption of novel approaches to clinical operations management
• Strong problem-solver and business acumen
• Significant knowledge of Good Clinical Practice (GCP), International Conference on Harmonization (ICH) and other health authority guidelines/requirements regarding clinical research and development
• Excellent verbal, written and interpersonal skills and communication skills
• Extensive experience with all phases of clinical development including global regulatory submissions

Education amp; Relevant Work Experience:

• Advanced degree in a relevant scientific field
• A minimum of fifteen years of experience in the pharmaceutical/biotechnology industry and at least 10 years of relevant experience in a clinical research, clinical operations and clinical quality environment
• Demonstrated successful experience as a manager of high performing teams and influencing across a matrix organization
• Experience in Hematology/Oncology, Neurology, Immunology and Rare Disease Drug Development preferredPhysical amp; Travel Requirements:

Physical amp; Travel Requirements:

• Less than 10% travel

Job Rewards and Benefits