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If you are a current Jazz employee please apply via the Internal Career site.
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 visitwww.jazzpharmaceuticals.comfor more information.
Brief Description:
This position is responsible for leading efficient, innovative, clinical pharmacology, PK/PD, and/or
population PK study design, analysis, interpretation, and reporting to support international drug
development programs. Working through cross-functional teams, this individual will lead the overall
global clinical pharmacology strategy for multiple Jazz portfolio products, from research to
registration and beyond.
Essential Functions/Responsibilities
ï‚· Development of the clinical pharmacology strategy of multiple programs
ï‚· Clinical study protocol design, data analysis/interpretation, and reporting of studies by
preparing CSRs and various regulatory documents (INDs, NDA’s, IB’s, etc.)
o This includes determining scope, design, planning and analysis of phase 1-4
pharmacokinetic and pharmacodynamics studies, including developing appropriate
population PK models, and PK/PD analysis required from a development and
regulatory perspective to take a project from its existing or concept stage to
commercialization. Planning, preparing and reviewing drug development plans and
regulatory filings
ï‚· Direct and manage the activities of staff within the Clinical Pharmacology group
ï‚· Contribute to the preparation of relevant sections of regulatory submissions including
IND, and NDA/BLA documents
ï‚· Address queries from regulatory agencies during reviews and inspections
ï‚· Identify and manage consultants and vendors supporting clinical pharmacology
studies
ï‚· Effective participation on cross functional teams representing early development
department to insure integration of modern pharmacology principles into project plans
Required Knowledge, Skills, and Abilities
ï‚· PhD or MD with 10+ years of experience with clinical pharmacokinetic and
pharmacokinetic-pharmacodynamic data analysis
ï‚· Strong understanding of clinical pharmacology and pharmacometrics principles and
the drug development process
ï‚· Good working knowledge of software for PK/PD analysis (eg Phoenix WinNonlin, R,
ADAPT and NONMEM)
ï‚· Ability to work both independently and on strong cross functional teams
ï‚· Experience in regulatory agency interactions
ï‚· Excellent written and oral communication skills including good presentation skills
ï‚· Collaborative and flexible in personal interactions at all levels of the company
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 full and complete base pay range is: $188,000.00 - $282,000.00
Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis.
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.html.
