Advanced Recruiting Partners · 1 week ago
Vice President Clinical Operations
United States
Full-time
Remote
Director/Executive
15+ years expAdvanced Recruiting Partners is seeking a Vice President of Clinical Operations to lead the strategic planning and execution of global Phase 1–3 clinical trials. This senior role involves overseeing trial operations, ensuring efficient execution, and collaborating with various stakeholders to support regulatory approvals and successful commercialization of therapies.
Human ResourcesRecruitingStaffing Agency
Responsibilities
Provide strategic and hands-on operational leadership for clinical studies and programs, with full accountability for the successful execution of late-stage clinical trials
Partner with senior clinical leadership to develop and implement operational plans that enable successful study execution
Maintain program-level responsibility for compound and study management and represent Clinical Operations on cross-functional program and study teams, as assigned
Ensure operational considerations are fully integrated into Clinical Development Plans and individual study protocols
Provide operational input into regulatory submissions including INDs, CTAs, NDAs, and BLAs, and support interactions with regulatory agencies to ensure operational readiness for filings and inspections
Ensure high-quality execution of all assigned studies and clinical programs
Lead cross-functional planning to develop integrated study plans and initial budgets
Review feasibility assessments provided by CROs and lead CRO selection activities
Validate CRO implementation plans through study close-out and clinical study report (CSR) development, ensuring alignment with agreed timelines, milestones, and budgets
Lead site selection, site qualification, investigator meetings, and study team meetings in collaboration with assigned Directors and Project Managers
Oversee CRO execution to ensure studies are delivered in accordance with approved plans, timelines, and budgets
Conduct comprehensive study risk assessments and ensure mitigation and contingency strategies are implemented
Proactively identify emerging risks and drive timely resolution
Lead operational strategy and execution for subject identification, recruitment, and retention to meet development and registration timelines
Champion innovative, technology-enabled recruitment and retention approaches, leveraging data and site partnerships to sustain enrollment momentum
Proactively identify enrollment and retention challenges and drive mitigation strategies
Provide executive-level oversight of CROs supporting assigned programs
Partner with Quality Assurance and Risk Management to ensure robust oversight frameworks are implemented for all studies
Design, implement, and continuously improve best-in-class SOPs and procedures supporting clinical study oversight and execution
Ensure ongoing inspection readiness by overseeing Trial Master File (TMF) operations and clinical systems, including CTMS, eTMF, EDC, IRT, and other digital platforms
Monitor CRO performance against scope of work, timelines, budgets, and quality metrics throughout the study lifecycle
Identify operational issues early, implement corrective actions, and escalate to governance committees when appropriate
Lead development and oversight of study- and program-level budgets, ensuring alignment with trial progress and financial forecasts
Oversee risk-based quality management (RBQM), centralized monitoring strategies, and risk mitigation plans
Analyze CRO performance trends and drive continuous improvement
Oversee investigator grant management, including budget development, contract execution, and payment processes, in collaboration with contracts, finance, and legal partners
Lead resource planning across assigned programs, ensuring appropriate staffing levels through effective utilization of employees and contractors
Foster a culture of accountability, innovation, and operational excellence
Recruit, mentor, and develop high-performing teams, supporting succession planning and leadership development
Provide direct and/or functional management, including performance evaluations, coaching, and career development
Support conflict resolution and team effectiveness across functions
Demonstrate strong initiative, attention to detail, and proactive prioritization in a fast-paced environment
Promote collaboration within an agile, team-based organizational structure
Exhibit exceptional written and verbal communication, organizational, interpersonal, and problem-solving skills
Qualification
Required
Bachelor's or Master's degree in a scientific, biological, life sciences, or related discipline
Minimum of 15 years of clinical trial management experience, including at least 5 years in senior leadership roles
Proven experience leading complex Phase III programs in a fast-paced biotechnology or pharmaceutical environment
Demonstrated success implementing innovative, technology-enabled patient recruitment strategies
Strong proficiency with clinical trial systems, including CTMS, eTMF, EDC, and IRT
In-depth knowledge of CNS
Comprehensive understanding of cross-functional clinical trial processes from start-up through close-out
Experience managing global clinical trials and internationally distributed teams
Deep working knowledge of ICH guidelines, GCP, CFR, and global regulatory requirements, including FDA and EMA standards
Experience supporting NDA or other regulatory submissions
Track record of managing multiple concurrent programs across early- and late-stage development
Strong strategic and operational project management skills
Ability to independently lead initiatives, assess complex challenges, and implement practical solutions
Proven ability to build effective relationships with vendors, investigators, consultants, and internal stakeholders
Excellent written, verbal, and presentation communication skills
Proficiency with Microsoft Project and Microsoft Office applications
Willingness and ability to travel globally, including conferences, site visits, and internal meetings
Company
Advanced Recruiting Partners
Advanced Recruiting Partners is a staffing agency that offers recruiting services for biopharmaceutical and life science industries.
2-10 employees
Funding
Current Stage
Early StageLeadership Team
Christopher Young
COO
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