Vice President of Clinical Operations

Summary

Join Roivant as the Vice President of Clinical Operations and play a pivotal role in advancing clinical development across the Roivant portfolio. You will lead the Clinical Operations team, establishing and executing innovative clinical trial strategies. This leadership position requires managing CROs, overseeing vendor selection, and ensuring high-quality data integrity. Success in this role demands strong leadership, communication, and collaboration skills, along with extensive experience in clinical operations management and global trial execution. You will be responsible for building and mentoring a high-performing team, while also contributing to the launch of new biotech subsidiaries. The ideal candidate will possess a strong entrepreneurial mindset and a proven ability to deliver results in a fast-paced environment.

Requirements

• Bachelor's Degree in a scientific discipline; advanced degree preferred
• 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 leading clinical operations teams to deliver on-time execution and results, including outsourced support
• Early and late phase investigational product development experience
• Demonstrated ability to set and prioritize goals and objectives; excellent time management, negotiation, problem-solving, and organizational skills
• Proven excellence in clinical operations strategy including simultaneous oversight of multiple trials, and ideally experience managing multiple vendors in dispersed project team environments
• Experience in building infrastructure (including SOPs)
• Ability to work independently and collaboratively in a fast-paced, matrixed team environment consisting of internal and external team members
• Entrepreneurial mindset, bringing in creative ideas to challenge the status quo of clinical trial execution
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
• Excellent understanding and demonstrated application of FDA guidelines, Good Clinical Practices, and applicable Standard Operating Procedures
• Strong leadership skills with the ability to innovate and collaborate with a small team to articulate clear clinical strategy
• Strong communication and presentation skills

Responsibilities

• Lead the Clinical Operations strategy, initiation, and execution of clinical trials across all phases, including CRO/vendor selection, site engagement, contracts & budgets, CRO oversight, and proactive risk management
• Provide excellent direct line management and training/mentoring of Clinical Operations team members
• Scope geographic region and site-specific approaches with substantial experience in global clinical trial execution for successful incubation of trials during diligence and launch post-transaction
• Demonstrate leadership in preemptively identifying and developing outlines of indication- and phase-specific operations plans before and during diligence
• Work cross-functionally to drive the strategy and own implementation for clinical programs and manage the integrated development plans to deliver against company goals
• Lead and supervise all aspects of study progress from concept to close-out to assure adherence to Good Clinical Practice, intended timelines, and achievement of study goals while ensuring quality in accordance with regulatory guidelines
• Serve as Clinical Operations point of contact for strategic governance bodies (e.g., Safety Team, Project Team), as well as portfolio planning and business development opportunities
• Lead Clinical Study teams in gathering and reporting key study data collection and presentation to use in support of regulatory filings, as well as project team and management communications
• Oversee identification, qualification, and selection of CROs and vendors needed to conduct clinical trials, including approval of Master Services Agreements and Task Orders with CROs
• Establish governance procedures for CROs and key clinical vendors, ensuring continuous performance oversight and process improvement
• Liaise with KOLs, Investigators, and clinical site staff to ensure optimal Sponsor-Site relationships
• Liaise effectively with Vant staff, including management and execution teams
• Provide scientific/clinical expertise in the design and interpretation of clinical studies
• Build and implement repeatable and scalable approaches to enrollment projections, geostrategy, and patient enrollment essential for future Vant planning and execution
• Implement novel technologies, platforms, tools to improve and scale core capabilities such as enrollment projections, geostrategy, and patient enrollment essential for future Vant planning and execution
• Ensure effective project or program communications and updates to internal and external stakeholders through meetings, presentations, and other methods