Senior Director, Clinical Operations

Responsibilities

• Accountable for the comprehensive oversight and management of all clinical studies in the portfolio, including providing strategic and tactical guidance to study teams to ensure timely operational execution and completion of clinical trials.
• Accountable for ensuring and maintaining ICH/GCP compliance and inspection-readiness across clinical programs.
• Develop and manage the resourcing plan for Clinical Operations including the assignment and allocations to clinical studies and leading the hiring of new team members, as needed.
• Accountable for developing detailed clinical program budgets and managing spend in accordance with plans.
• Coach and manage multiple direct reports; and mentor junior members of the team.
• Provide oversight of clinical research organizations (CROs) and other key vendors to ensure efficient, effective, and high-quality deliverables.
• Serve as the primary escalation point for issues related to operational execution and risk mitigation.
• Oversee the development of vendor specifications, project scope, and accountable for vendor selection.
• Oversee the establishment of KPIs, KRIs and stage-appropriate governance structures to drive and measure vendor performance.
• Oversee set-up and implementation of effective investigator and site training; facilitate compliance and program-related training for internal and external study team members as appropriate.
• Lead, participate, and/or contribute to the overall Clinical Development Plan as needed, including but not limited to the forecasting of study timelines, feasibility, country selections, and estimated budget.
• Oversee the review of study invoices and participate in accrual reviews to monitor and track the financial status of the study in relation to the budget.
• Prepare and present at senior management meetings, as needed, under the guidance of SVP, Development Operations.
• Accountable for establishing clinical operations SOPs, Work Instructions, guidelines, standards, related QS documents, and best practices.
• Lead and/or sponsor infrastructure initiatives, process improvements and enhancements, change management, and ad hoc business projects.

Qualifications

• Bachelor’s degree required with 15+ years of global clinical operations experience, including oversight and management of large global clinical trials through CRO partnerships (or equivalent combination of higher education, training and experience).
• 8+ years of people leadership experience with demonstrated success in building, coaching, and leading high-performing teams.
• Oncology or rare disease experience is a plus.
• Comprehensive understanding of ICH and GCP guidelines, as well as applicable regulations and best practices.
• Deep experience with clinical operations systems, processes, and vendor management models.
• Exceptional organizational and prioritization skills with strong attention to detail, coupled with ability to maintain strategic, enterprise level perspective.
• Effective communicator with the ability to influence and engage internal and external stakeholders at all levels, including senior leadership.
• Proven ability to think strategically while driving disciplined execution.
• Demonstrated critical and creative thinking, resourcefulness and initiative, and problem-solving skills.
• Proven ability to work independently and interdependently while exercising initiative, adaptability, and sound judgment.
• Demonstrated proficiency in Microsoft Word, PowerPoint, and Excel.
• Commitment to operating in alignment with Pliant’s values and culture.