Senior-level Clinical Operational leader who drives and leads the strategy for the implementation, execution, and oversight of patient centricity and site relationship initiatives for the clinical trial program. Accountable for working cross functionally to implement strategies to ensure that both the patient and site voices are front and center with our clinical trial protocol design and clinical trial operations.

Designs strategies which are targeted towards improving clinical trial intelligence, optimizing relationships with clinical trial sites in new and ongoing trials, devising and executing site engagement plans and generally ensuring that patients and sites are involved with designing clinical trial protocols, endpoints and study essential documents. Typically requires close engagement with advocacy support groups. Also, building capabilities to support continuous site and patient engagement, working with other Senior Leaders in the organization such as Medical Affairs, Clinical Development, CMO Office. This role will actively contribute to the implementation of strategy to support the prioritization of work across the GPSE organization in line with business priorities and the priorities supporting GCDO and Clinical Development.

Deputizes for Director, GPSE.

Essential Functions

• Help department head to drive the development of the annual and long-term strategy, goals for the department in line and support with the R&D and business goals and vision.
• Contribute to planning to ensure optimized strategy for prioritized projects.
• Lead and develop action plans to address issues with clinical studies, investigational sites, and CROs.
• Provide line management of GPSE Managers and Specialists, including training, administrative oversight, professional development, and performance appraisals.
• Actively lead the operational oversight and development of strategic direction for site and patient research insight panels development and ensure proper resourcing and planning for GPSE to support project management of cross functional team members.
• Develop strategy for identifying and establishing network of high performing/high quality clinical trial sites and key opinion leaders. Implement the strategy for maintaining long-standing relationships.
• Develop annual strategy, timelines and resources to support SPECS (Site and Patient experience) workshop process for clinical trial teams to conduct workshops and develop training/site materials.
• Develop and execute strategy to support teams for new site evaluation/engagement and tracking.
• Work with senior leaders cross-functionally among multiple departments, partner on shared tasks and study activities (i.e., Study Feasibility, Global Monitoring, Clinical Development, Clinical Operations, Global Advocacy)
• Develop and track Key Performance Indicators (KPIs), metrics and risks for GPSE
• Responsible for leading the development of work instructions/procedural guides for GPSE.

Required Knowledge, Skills, and Abilities

• Management experience with direct reports Expertise in the areas of drug development, operations, and strategic planning, specifically management of clinical trial operations
• Excellent organizational skills, self-starter
• Demonstrate experience of study start up and vendor oversight
• Demonstrated experience managing and mentoring clinical team members.
• Demonstrated knowledge of international clinical pharmaceutical standards, ICH/GCP guidelines, and regulatory compliance.
• International experience is highly preferred.
• Demonstrates ability to work independently and in a team environment
• Excellent communication/interaction skills and experience in a dynamic and growing organization
• CRA monitoring-related experience or Clinical trial management experience within pharma/CRO and/or Biotech industries.
• Demonstrates working knowledge of company SOPs, GCP, ICH guidelines and global regulatory guidelines.
• Competent with standard and job-specific computer applications, including Microsoft Office, SharePoint, CTMS, eTMF and Electronic Data Capture systems
• Excellent oral and written communication skills and strong organizational and prioritization abilities.
• Travel as required, including domestic and international
• Previous experience with risk-based monitoring approaches is preferred

Required/Preferred Education and Licenses

• BA/BS, nursing degree, or advanced degree. Degree in the life sciences preferred
• At least 10 years’ experience in the clinical research industry
• Ability to speak and understand multiple languages is preferred
• Experience in CNS and / or oncology 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.

FOR US-BASED CANDIDATES ONLY

Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $148,000-$194,250. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's qualifications, skills, and experience.

At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.

The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits