Jazz Pharmaceuticals
Associate Director, Clinical Operations
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Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information.
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.
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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
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Required/Preferred Education And Licenses
- Bachelor of Science/Master of Science degree in a related discipline, or equivalent work experience. Advanced degree is preferred.
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.
The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html.
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