Associate Director, Clinical Operations

Jazz Pharmaceuticals; Cambridge; On-site; GBP 110,000 - 150,000; Full time

Job summary

Jazz Pharmaceuticals is seeking an experienced clinical operations leader to plan and deliver complex development programs. You will partner with therapeutic and functional leadership to define strategy, align resources, and drive timelines, budgets and quality across global studies.

The role requires extensive clinical research experience (10+ years), strong regulatory knowledge, and the ability to mentor and influence cross-functional teams in a fast-paced environment.

Qualifications

• Extensive experience in clinical research within pharma/biotech (10+ years).
• Proficient understanding of global trial regulations, ICH/GCP and regulatory compliance.
• Interact with functional leaders and major vendors on program strategy and execution.
• Strong financial acumen in managing trial budgets and forecasting spend.
• Collaborate cross-functionally and influence stakeholders to drive decisions.
• Leadership abilities to mentor, influence and drive team performance.
• Manage complex projects, prioritize demands and solve problems in fast-paced settings.

Responsibilities

• Provide clinical operations expertise to planning and delivery of development programs.
• Define and operationalize program strategy with therapeutic leadership.
• Advise on resourcing for applied operational strategy.
• Contribute to development plans, governance reviews and risk management.
• Drive development and alignment of clinical documents (protocols, reports, brochures).
• Oversee country selection, feasibility and study start-up activities.
• Manage study timelines, budgets, forecasts and deliverables.
• Support vendor selection, contracting and oversight for quality and compliance.
• Escalate risks and issues; implement mitigation plans.
• Lead cross-functional program excellence with CD, Data Mgmt, Biostatistics, Reg, etc.

Skills

Clinical operations

Regulatory compliance

Budget forecasting

Cross-functional collaboration

Leadership

Stakeholder management

Risk management

Education

Bachelor/Master in related discipline (advanced degree preferred)

Job description

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.

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