Vice President – Clinical Operations

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide comprehensive operational leadership and accountability for the Sponsor in clinical programs encompassing Phase 1/2 studies as well as the registrational Phase 3 program.

• Convert clinical development strategies into a cohesive global operational plan that includes sequencing, timelines, country and site strategies, enrollment, resources, vendors, budgets, systems, and dependencies.

• Act as the senior Study Management representative within the cross-functional program team.

• Develop and uphold integrated program plans and critical paths across various studies.

• Contribute operational insights into protocol development and study design.

• Direct global feasibility assessments, trial optimization, enrollment modeling, and country/site placement strategies.

• Lead the strategy for global site start-up and activation while managing critical paths.

• Establish start-up metrics, dashboards, predictive indicators, and a single source of truth for program execution.

• Provide hands-on oversight from the Sponsor for Phase 1 and Phase 2 studies.

• Ensure operational readiness for the registrational Phase 3 program.

• Identify, evaluate, escalate, and mitigate operational risks.

• Create CRO governance frameworks and hold CROs and vendors accountable for delivery, quality, timelines, enrollment, start-up, issue resolution, and budgets.

• Manage the selection of CROs/vendors, scope development, contracting strategies, change-order management, and performance oversight.

• Cultivate relationships with investigators and sites, integrating their insights into the operational strategy.

• Utilize AI, advanced analytics, automation, digital technologies, and AI-driven workflows to enhance trial planning, execution, forecasting, oversight, and decision-making.

• Collaborate with Clinical Development, Regulatory Affairs, Biometrics/Data Management, Safety, Quality, Technical Operations, Development Services, technology, and data science teams.

• Deliver decision-oriented program updates to senior leadership.

• Ensure readiness for inspections, compliance with GCP, oversight from the Sponsor, and documentation of decisions, risks, escalations, and governance.

• Mentor members of the Study Management team and foster program-management capabilities within Global Clinical Operations.

⛳️ Requirements

• Bachelor’s degree in life sciences or a related discipline.

• Over 20 years of progressive experience in clinical operations and Study Management within a Sponsor organization.

• Significant leadership experience overseeing global clinical programs.

• Proven track record in leading complex global late-stage and registrational clinical programs, including Phase 3 studies, from operational strategy and feasibility through start-up, execution, database lock, and readiness for regulatory submission.

• Experience in providing comprehensive program-level operational leadership across multiple studies.

• Extensive expertise in global feasibility, country and site strategies, enrollment modeling, site start-up and activation, monitoring strategies, patient recruitment and retention, and risk management.

• In-depth knowledge of CRO governance and outsourced clinical development.

• Familiarity with vendor selection, contracting, governance, performance management, escalation, and holding external partners accountable.

• Experience in planning and preparing large-scale registrational programs well ahead of Phase 3 initiation.

• Proficient in the use of advanced analytics, automation, AI-enabled tools, or digital technologies in clinical trials.

• Strong understanding of ICH-GCP and relevant global regulatory requirements.

• Experience in supporting FDA and other major health authority interactions, as well as maintaining inspection-ready clinical programs.

• Exceptional cross-functional leadership abilities with the capacity to influence senior stakeholders and drive decisions without direct authority.

• Excellent skills in executive communication, judgment, problem-solving, and decision-making.

• Legal authorization to work in the United States.

• Advanced degree is preferred.

• Experience in a small or mid-size biotechnology setting is strongly preferred.

🏝️ Benefits

• Equity

• Annual bonus potential

• Medical insurance

• Dental insurance

• Vision insurance

• Unlimited vacation

• Parental leave

• Employee assistance program

• Voluntary life insurance

• Voluntary disability insurance

• 401(k) with a generous company match

• Up to 20–30% domestic and international travel