Role Overview
The Associate Director, Clinical Operations provides senior clinical-operations subject matter expertise and contributes to planning and delivery of clinical development programs across scope, quality, budget, timelines and risk. The role partners with therapeutic and functional leadership to define and operationalize program strategy, supports governance decisions, oversees study-team deliverables and drives operational excellence across clinical programs.
Clinical Development & Program Strategy
Provide subject matter expertise for planning and delivery of clinical development programs.
Ensure programs are managed to agreed scope, quality, budget and timelines while proactively managing risk.
Partner with therapeutic and functional leaders to define and operationalize clinical program strategy.
Advise functional leadership on resource requirements needed to execute the operational strategy.
Provide clinical-operations expertise to clinical development plans submitted for governance-committee review.
Clinical Documents & Study Planning
Drive development and alignment of key clinical documents, including protocols, clinical study reports and investigator brochures.
Provide clinical-operations input into country selection and feasibility assessments.
Support project start-up and clinical-study delivery through appropriate country and site feasibility activities.
Provide operational expertise throughout study planning and execution.
Study & Program Oversight
Oversee study-team deliverables, including patient enrollment, milestones and inspection readiness.
Develop and oversee program timelines, budgets, forecasts and key deliverables.
Ensure clinical programs are executed on time, within budget and to required quality standards.
Contribute to study scope and provide approvals within delegated authority.
Contribute to vendor selection, contracting and ongoing vendor oversight.
Ensure vendors meet required quality, compliance and performance expectations.
Risk Management & Escalation
Identify risks and issues affecting program deliverables.
Develop and implement mitigation plans and action plans.
Serve as an escalation point for clinical-study teams regarding risks and issues involving studies, sites and vendors.
Apply structured problem solving to complex clinical-operations challenges.
Cross-Functional Collaboration
Drive operational excellence through collaboration with Clinical Development, Data Management, Biostatistics, Regulatory and other functional stakeholders.
Influence cross-functional stakeholders to support strategic and operational decisions.
Work effectively with functional leaders, major vendors and, where required, senior leadership.
Contribute clinical-operations expertise to broader cross-functional initiatives.
Leadership & People Development
Provide leadership and program management for assigned non-drug projects, including cross-functional improvement and change initiatives.
Contribute as a subject matter expert to functional and cross-functional initiatives.
Mentor, coach and support people development as appropriate.
Influence matrix teams and drive effective team performance.
Participate actively in internal and external networking within and outside the therapeutic area.
Share best practices and lessons learned across the organization.
Change & Operational Excellence
Act as an early adopter of new ways of working.
Serve as an ambassador for organizational change.
Drive implementation and utilization of outputs from improvement initiatives.
Support continuous improvement of clinical-program execution and operational processes.
Regulatory & Compliance Expertise
Extensive understanding of global clinical-trial regulations.
Proficient knowledge of ICH/GCP guidelines.
Ensure clinical-program activities align with regulatory and compliance requirements.
Maintain inspection readiness across assigned clinical programs.
Financial & Vendor Management
Apply financial acumen to clinical-trial budget management.
Manage forecasts and monitor clinical-program spend.
Make cost-effective operational decisions aligned with program goals.
Support vendor selection, contracting and ongoing performance oversight.
Education & Experience
Typically 10+ years of clinical-research experience within the pharmaceutical or biotechnology industry.
Deep expertise in clinical operations.
Bachelor's or Master's degree in a related discipline, or equivalent work experience.
Advanced degree preferred.
Leadership Competencies
Strong strategic and operational decision-making.
Ability to influence senior stakeholders and functional leaders.
Strong mentoring and coaching capabilities.
Ability to manage complex projects and competing priorities.
Strong problem-solving capability in a fast-paced environment.
Ability to operate effectively in a matrix organization.
Work Arrangement
Remote/home-based position.
Locations listed are Cambridge, Cambridgeshire and London, UK.
Full clinical-development and cross-functional responsibilities may involve interaction with global teams and external vendors.
Benefits & Total Rewards
Jazz Pharmaceuticals states that successful candidates may be eligible for benefits including medical, dental and vision insurance, a retirement savings plan and flexible paid vacation. The posting directs candidates to Jazz's benefits resources for further information. Specific compensation figures are not provided in the supplied posting.