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Associate Director, Clinical Operations

đź•’ July 8

🇬🇧 United Kingdom – Remote

⏰ Full Time

đźź  Senior

👨‍⚕️ Medical Director

🇬🇧 UK Skilled Worker Visa Sponsor

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Logo of Jazz Pharmaceuticals

Jazz Pharmaceuticals

1001 - 5000 employees

Founded 2003

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Jazz Pharmaceuticals is a biopharmaceutical company dedicated to developing innovative medicines that address serious unmet medical needs. With a strong commitment to research and development, Jazz focuses on creating life-changing therapies, emphasizing the importance of collaboration, diversity, and employee engagement in its operations. The company prides itself on transforming patients' lives through its meaningful product offerings and a culture that fosters enthusiasm and flexibility.

đź“‹ Description

• 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.

🎯 Requirements

• Extensive experience in clinical research within the pharmaceutical or biotechnology industry (typically 10+ years) • 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 • Bachelor of Science/Master of Science degree in a related discipline, or equivalent work experience. Advanced degree is preferred.

🏖️ Benefits

• medical, dental and vision insurance • retirement savings plan • flexible paid vacation

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