Associate Director, Clinical Operations

Essential Functions/Responsibilities

• Provide subject matter expertise and contribute to the planning and delivery of a clinical development program to scope, quality, budget, time and managing risk as assigned by therapeutic and compound leadership
• Partner with therapeutic and functional leadership to define and operationalize program strategy
• Advise functional leadership on resourcing requirement for the applied operational strategy
• Responsible for providing clinical operations expertise into the clinical development plans for review by governance committees
• Drive the development and alignment of clinical documents (protocols, clinical study reports, investigator brochures, etc.), providing clinical operations expertise.
• Provide clinical operations expertise into the country selection and feasibility to support project start up and delivery.
• Oversee study team deliverables, including enrollment, milestones, and inspection readiness
• Develop and oversee program timelines, budgets, forecasts, and key deliverables to ensure programs are executed on time, within budget, and with quality.
• Contribute to study scope and provide approvals within delegated authority; contribute to vendor selection, contracting, and ongoing oversight to ensure quality, compliance, and performance
• Identify risks and issues related to program deliverables; develop and implement mitigation and action plans.
• Act as the point of escalation for clinical study teams for risk and issues related to clinical studies, sites, and vendors.
• Drive operational excellence across clinical programs through cross functional collaboration with Clinical Development, Data Management, Biostatistics, Regulatory, and other stakeholders.
• Responsible for leadership and program management of non drug project work as assigned, e.g. cross functional improvement/change initiatives
• Contribute to functional and cross functional initiatives as Subject Matter Experts
• Mentor, coach and support people development as appropriate
• Actively participate in networking both within and outside the therapeutic area, sharing best practices and lesson learnt
• Be an early adopter for new ways of working and act as an ambassador for change, driving the implementation and utilization of initiative outputs.

Required Knowledge, Skills, and Abilities

• Extensive experience in clinical research within the pharmaceutical or biotechnology industry (typically 10+ years), with deep expertise in clinical operations.
• Proficient understanding of global clinical trial regulations, ICH/GCP guidelines, and regulatory compliance requirements
• Capability to interact with functional leaders and major vendors, and in some cases senior leadership, on matters concerning program strategy and execution.
• Proficient financial acumen in managing clinical trial budgets, forecasting spend, and making cost effective operational decisions aligned with program goals
• Proven ability to collaborate cross functionally and influence stakeholders to drive strategic and operational decisions
• Leadership capabilities, including the ability to mentor, influence, and drive team or matrix performance
• Ability to manage complex projects, prioritize competing demands, and solve problems in a fast paced environment

Required/Preferred Education and Licenses

• Bachelor of Science/Master of Science degree in a related discipline, or equivalent work experience. Advanced degree is preferred.