Vice President of Clinical Operations

Vice President of Clinical Operations

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 required
• Experience developing clinical study protocols in conjunction with a study team required
• Track record leading clinical operations teams to deliver on time execution and results, including outsourced support
• Early and late phase investigational product development experience required
• 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) required
• 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 ability to innovate and collaborate with a small team to articulate clear clinical strategy
• Strong communication and presentation skills

Responsibilities

• Leadership responsibility for Clinical Operations strategy, initiation and execution of clinical trials across all phases, including (but not limited to) CRO/vendor selection, site engagement, contracts & budgets, CRO oversight, and proactive risk management to ensure the quality conduct of trials with a high level of data integrity
• Provide excellent direct line management and training/mentoring of Clinical Operations team members, creating a nimble, versatile, world-class, high performing operations team
• Scoping 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 is highly critical
• Demonstrate leadership in preemptively identify and develop outlines of indication- and phase-specific operations plan before and during diligence to arrive at the most realistic estimates of enrolment and data availability timelines in the integrated development plan underwritten in the Investment Thesis
• 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 CRO
• 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 team
• 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

Preferred Qualifications

• Advanced degree preferred
• Entrepreneurial mindset, bringing in creative ideas to challenge the status quo of clinical trial execution