Vice President of Clinical Operations (Remote)

Roivant Sciences - New York, NY

Full-time - Senior

Remote - New York, NY

Professional, Scientific, and Technical Services

About the position

The Vice President of Clinical Operations at Roivant will be instrumental in advancing clinical development programs across the company's portfolio and supporting the launch of new biotech subsidiaries. This role involves establishing and executing innovative strategies for clinical trial execution, ensuring alignment with company goals, and collaborating with cross-functional teams. The individual will lead the Clinical Operations team, manage trial execution across all phases, and maintain high data quality and integrity throughout the process.

Responsibilities

• Lead Clinical Operations strategy and execution of clinical trials across all phases.
• Manage CRO/vendor selection, site engagement, contracts & budgets, and proactive risk management.
• Provide direct line management and mentoring to Clinical Operations team members.
• Scope geographic region and site-specific approaches for global clinical trial execution.
• Identify and develop operation plans for clinical trials during diligence and launch phases.
• Drive strategy and implementation for clinical programs and manage integrated development plans.
• Oversee study progress from concept to close-out, ensuring adherence to Good Clinical Practice and regulatory guidelines.
• Serve as the Clinical Operations point of contact for strategic governance bodies and business development opportunities.
• Lead Clinical Study teams in data collection and reporting for regulatory filings and project communications.
• Oversee identification and selection of CROs and vendors for clinical trials, including contract approvals.
• Establish governance procedures for CROs and clinical vendors, ensuring performance oversight and process improvement.
• Liaise with KOLs, Investigators, and clinical site staff to maintain optimal Sponsor-Site relationships.
• Provide scientific and clinical expertise in the design and interpretation of clinical studies.
• Build and implement scalable approaches to enrollment projections and patient enrollment for future planning.
• Ensure effective communication and updates to stakeholders through various methods.

Requirements

• Bachelor's Degree in a scientific discipline.
• 15+ years of clinical operations management experience, including trial leadership experience.
• Experience managing CROs and key clinical vendors.
• Experience developing clinical study protocols in conjunction with a study team.
• Track record of leading clinical operations teams to deliver on-time execution and results.
• Early and late phase investigational product development experience.
• Demonstrated ability to set and prioritize goals and objectives with excellent time management skills.
• Proven excellence in clinical operations strategy and oversight of multiple trials.
• Experience in building infrastructure, including SOPs.
• Ability to work independently and collaboratively in a fast-paced, matrixed environment.
• Entrepreneurial mindset with creative ideas to challenge the status quo.
• Analytical thinker with excellent problem-solving skills.
• Strong understanding of FDA guidelines, Good Clinical Practices, and applicable SOPs.
• Strong leadership skills with the ability to innovate and collaborate.
• Excellent communication and presentation skills.