The Vice President, Clinical Operations will lead and manage the Clinical Operations, Strategic Outsourcing & Data Management teams. These three teams partner with other functions across Jazz to create the strategies for Jazz Pharmaceuticals studies portfolio. Through these three teams the VP, Clinical Operations is responsible for the execution of all Jazz Pharmaceuticals sponsored clinical trials.
- Provide oversight, leadership, and expert perspective to the Clinical Operations, Strategic Outsourcing & Data Management teams in operational aspects of all clinical studies worldwide in accordance with the Jazz Values.
- Responsible for implementation and execution of the global clinical studies strategy.
- Ensure consistency, quality and compliance with global clinical standards.
- Assess and implement innovative clinical trial & data management approaches.
- Provide strategic direction for outsourcing, oversight and experience in CRO and vendor selection, and provide ongoing executive management to selected partners through joint steering committees and through the Strategic Outsourcing team.
- Oversee technical expertise for the development of clinical trial documents and trial conduct.
- Coordinate closely with Clinical Development, Biostatistics, Drug Safety, Quality, Legal, Finance, Product Development, Project Management and Regulatory to ensure operational excellence.
- Be the representative of the department and an active contributing member in Jazz R&D governance bodies which includes Protocol Review Committee, Development Project Review Committee, R&D Leadership Team, etc.
- Oversee the preparation and management of clinical trial budgets and timelines
- Ensure the appropriate communication and reporting of trial related activities and metrics
- Participate in due diligence with Corporate Development.
- Provide direction and mentorship to staff including setting goals that are aligned with both Corporate and project goals.
- Forecast resourcing requirements to meeting the needs of current and projected study activity. Partner with Talent Acquisition to recruit talent to meet business needs and foster department growth.
- Maintain inspection readiness across all programs.
- Leadership with strong results orientation
- Ability to work on and solve complex problems.
- Ability to prioritize and handle multiple tasks simultaneously.
- Proven ability to foster team productivity, cohesiveness, and collaboration.
- Excellent communication/interaction skills and experience in a dynamic and growing organization.
- Ability to build relationships outside of the organization, cross-functionally and across geographic locations
Professional Background / Experience
- Advanced degree (e.g. MS, MBA, PhD) and a minimum of 15 years related experience in the pharmaceutical or biotechnology industry. Hematology/Oncology and/or Neurology experience preferred.
- Expertise in the areas of global drug development, operations, and strategic planning, and management of clinical trial operations.
- Demonstrated experience managing and mentoring team members.
- Demonstrated knowledge of international clinical pharmaceutical standards, ICH/GCP guidelines, and regulatory compliance.
- Demonstrated successful experience of data management, data review and analysis, and drug safety and pharmacovigilance.
- Successful experience in outsourced clinical trial operations environments.
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.