Assoc Director, Pharmacology

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.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.

This position will provide contribution in design, analysis and reporting of clinical pharmacology and pharmacometrics programs to support small and large molecule compounds from discovery through registration and post-marketing.

Brief Description:

This position is responsible for pharmacometrics analyses, including population PK, PK/PD, PBPK, and/or exposure-response (E-R), planning, interpretation, and reporting to support global drug development programs. Working through cross-functional teams, this individual will develop and implement of model-informed drug development (MIDD) strategy for multiple Jazz portfolio products, from research to registration and beyond.

Essential Job Functions:

Job Responsibilities

• Development and execution of the pharmacometrics strategy of multiple programs
• Design, perform, interpret and report of population PK, PK/PD, PBPK and E-R analyses
• Provide hands-on population PK, PK/PD, PBPK, E-R modeling and simulation support for development projects
• Responsible for planning, executing, and reporting of formal pharmacometric analyses included in CSRs, HA submissions, and responses to questions from health authorities
• Contribute to the preparation of relevant sections of regulatory submissions including IND, and NDA/BLA documents
• Address queries from regulatory agencies during reviews and inspections
• Manage pharmacometrics analyses performed by venders
• Effective participation on cross functional teams to ensure integration of MIDD principles
• Provides mentorship to scientists on MIDD and Pharmacometrics

Required Knowledge, Skills, and Abilities

• PhD or MD in pharmaceutical sciences, biomedical engineering, or mathematical/statistical sciences with 5+ years of experience in clinical pharmacokinetic and pharmacokinetic-pharmacodynamic data analysis
• Understanding of clinical pharmacology and pharmacometrics principles and the drug development process
• Prior experience in performing modeling and simulation tasks using software for population PK, PK/PD, PBPK or E-R analysis (eg. NONMEM, Monolix, Phoenix WinNonlin, R, GastroPlus, SimCYP, and ADAPT)
• In-depth knowledge of current practices and issues in Clinical Pharmacology and Pharmacometrics
• Excellent written and oral communication skills including good presentation skills
• Ability to navigate and be successful in a fast-paced, highly matrixed work environment
• Ability to work independently and collaboratively in a multidisciplinary team environment
• Embody and model Jazz core values

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 $160,000-$210,000. 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