Develop and lead the execution of strategic roadmap and objectives for the clinical data platform(s) Partner cross functionally to optimize Jazz's use of the clinical data platform(s) and develop/implement change management strategies to maximize adoption Provide vision, motivation, leadership, and mentoring to the Clinical Data Innovation team. Plan, hire and adapt resou

Facilitates the design, development, production and delivery of Global Clinical Development Operations (GCDO) digital systems in order to achieve operational excellence, optimize data quality and realize efficiencies wherever possible Represents their department and collaborates with Information Services (IS), Clinical Operations, Outsourcing, Medical Writing, Clinical Da

Provide subject matter expertise (SME) in Biologics Formulation and DP process development including lyophilized presentation development. Author and review CMC modules of IND and BLA filings Support tech transfer of biologics drug product processes to commercial scale contract manufacturing organizations (CMOs) Serve as Person in Plant (PiP) during batch production to ac

Strategic Leadership Provide strategic direction and leadership for the clinical development of BTC and GEA Oncology program, aligning with overall corporate goals and objectives. Clinical Development Planning Develop and execute comprehensive Global clinical development plans for Oncology in the context of BTC and GEA, including study design, protocol development, and re

The Late Development Team Lead (LDTL) is a critical role in the organization that has a significant impact on the late product lifecycle of a product or platform of products. The LDTL is accountable for leading the Late Development Team (LDT) in establishing and executing on a global product(s) strategy, which integrates scientific rationale, clinical development, nonclin

The Executive Director, Late Stage Oncology Clinical Operations will lead a team of clinical operations professionals charged with the execution and delivery of our Oncology Phase 1 3 pipeline. S/he must have extensive knowledge and experience in solid tumor clinical development from planning through approvals. This includes strategic operational planning, project cost es

The Late Development Team Lead (LDTL) is a critical role in the organization that has a significant impact on the late product lifecycle of a product or platform of products. The LDTL is accountable for leading the Late Development Team (LDT) in establishing and executing on a global product(s) strategy, which integrates scientific rationale, clinical development, nonclin

This position will provide a strategic leadership in design, oversight, analysis and reporting of pharmacometrics programs to support small and large molecule compounds in oncology from discovery through registration and post marketing. Essential Functions This position has varying responsibilities relating to clinical pharmacology, pharmacokinetics (PK), and pharmacodyna

Excellent working knowledge on pharmacovigilance and drug safety regulations (ICH, GxP) Work to streamline and optimize business processes based on industry best practices. Generate listings from the safety database, both standard reports and ad hoc queries. Conduct peer review of safety database queries for accuracy and completeness of the results. Coordinate safety syst

may require a work schedule that may include working outside of "normal" work hours, to meet business demands. Occasional public contact requiring appropriate business apparel. 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

The Director, Toxicology is accountable for managing the global nonclinical regulatory and investigative toxicology of assigned Jazz portfolio products, and likewise to support his/her reports overseeing those products. They will collaborate with their direct reports and other members of the toxicology group, Early Development non clinical scientists, and members of Jazz

The Integrated Data Analytics and Statistical Programming Group (IDASP) within the Department of Data sciences is responsible for developing software for the analysis of clinical study data in accordance with departmental SOPs and guidelines. Essential Functions Attend multi disciplinary team meetings, representing the programming function. Create or review and approve pr

Develop and implement regulatory strategies to facilitate the progress of programs in all phases of development Serve as the Regulatory Affairs representative on project teams; assure the progress of projects by providing direction, solutions, and feedback to the teams Lead regulatory interactions with health authorities, marketing partners, and vendors for their products