Jazz Pharmaceutical
Director, Clinical Pharmacology ( UK or US Remote )
Jazz Pharmaceutical, San Francisco, California, United States, 94199
If you are a current Jazz employee please apply via the Internal Career site
Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical 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 and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit
www.jazzpharma.com
and follow @JazzPharma on Twitter.
Job Description
Brief Description:This position is responsible for leading efficient, innovative, clinical pharmacology, PK/PD, and/orpopulation PK study design, analysis, interpretation, and reporting to support international drugdevelopment programs. Working through cross-functional teams, this individual will lead the overallglobal clinical pharmacology strategy for multiple Jazz portfolio products, from research toregistration and beyond.Essential Functions/Responsibilities• Development of the clinical pharmacology strategy of multiple programs• Clinical study protocol design, data analysis/interpretation, and reporting of studies bypreparing CSRs and various regulatory documents (INDs, NDA's, IB's, etc.)o This includes determining scope, design, planning and analysis of phase 1-4pharmacokinetic and pharmacodynamics studies, including developing appropriatepopulation PK models, and PK/PD analysis required from a development andregulatory perspective to take a project from its existing or concept stage tocommercialization. Planning, preparing and reviewing drug development plans andregulatory filings• Direct and manage the activities of staff within the Clinical Pharmacology group• Contribute to the preparation of relevant sections of regulatory submissions includingIND, and NDA/BLA documents• Address queries from regulatory agencies during reviews and inspections• Identify and manage consultants and vendors supporting clinical pharmacologystudies• Effective participation on cross functional teams representing early developmentdepartment to insure integration of modern pharmacology principles into project plansRequired Knowledge, Skills, and Abilities
• PhD or MD with 10+ years of experience with clinical pharmacokinetic andpharmacokinetic-pharmacodynamic data analysis• Strong understanding of clinical pharmacology and pharmacometrics principles andthe drug development process• Good working knowledge of software for PK/PD analysis (eg Phoenix WinNonlin, R,ADAPT and NONMEM)• Ability to work both independently and on strong cross functional teams• Experience in regulatory agency interactions• Excellent written and oral communication skills including good presentation skills• 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
Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical 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 and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit
www.jazzpharma.com
and follow @JazzPharma on Twitter.
Job Description
Brief Description:This position is responsible for leading efficient, innovative, clinical pharmacology, PK/PD, and/orpopulation PK study design, analysis, interpretation, and reporting to support international drugdevelopment programs. Working through cross-functional teams, this individual will lead the overallglobal clinical pharmacology strategy for multiple Jazz portfolio products, from research toregistration and beyond.Essential Functions/Responsibilities• Development of the clinical pharmacology strategy of multiple programs• Clinical study protocol design, data analysis/interpretation, and reporting of studies bypreparing CSRs and various regulatory documents (INDs, NDA's, IB's, etc.)o This includes determining scope, design, planning and analysis of phase 1-4pharmacokinetic and pharmacodynamics studies, including developing appropriatepopulation PK models, and PK/PD analysis required from a development andregulatory perspective to take a project from its existing or concept stage tocommercialization. Planning, preparing and reviewing drug development plans andregulatory filings• Direct and manage the activities of staff within the Clinical Pharmacology group• Contribute to the preparation of relevant sections of regulatory submissions includingIND, and NDA/BLA documents• Address queries from regulatory agencies during reviews and inspections• Identify and manage consultants and vendors supporting clinical pharmacologystudies• Effective participation on cross functional teams representing early developmentdepartment to insure integration of modern pharmacology principles into project plansRequired Knowledge, Skills, and Abilities
• PhD or MD with 10+ years of experience with clinical pharmacokinetic andpharmacokinetic-pharmacodynamic data analysis• Strong understanding of clinical pharmacology and pharmacometrics principles andthe drug development process• Good working knowledge of software for PK/PD analysis (eg Phoenix WinNonlin, R,ADAPT and NONMEM)• Ability to work both independently and on strong cross functional teams• Experience in regulatory agency interactions• Excellent written and oral communication skills including good presentation skills• 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