Associate Director, Pharmacometrics

Jazz Pharmaceuticals; Philadelphia (Philadelphia County); A distancia; USD 164.000 - 246.000; Jornada completa

Descripción de la vacante

Jazz Pharmaceuticals, Inc. in the United States seeks a pharmacometrics leader to guide population PK/PD analyses across multiple development programs, from research through registration.

You will design, perform and report PK/PD modeling and exposure–response analyses, support dose selection, and contribute to regulatory submissions while collaborating with cross-functional teams in a fast-paced, matrixed environment.

Formación

• PhD in pharmaceutical sciences, biomedical engineering, clinical pharmacology, or mathematical/statistical sciences with 5+ years of PK/PD data analysis.
• Strong understanding of pharmacometrics and the drug development process.
• Experience with PK/PD modeling software (NONMEM, Monolix, Phoenix WinNonlin, R, GastroPlus, SimCYP, ADAPT, PK-Sim).
• Experience with regulatory interactions is a plus.
• Ability to work independently and in cross-functional teams.
• Excellent written and oral communication and presentation skills.
• Embody Jazz core values.

Responsabilidades

• Develop the pharmacometrics strategy for multiple programs.
• Design, perform, interpret and report population PK, PK/PD and exposure–response analyses.
• Provide hands-on PK/PD modeling and simulation support for development projects.
• Design study protocols, analyze data, and prepare regulatory documents (INDs, NDAs, IBs).
• Plan and review drug development plans and regulatory filings.
• Contribute to regulatory submissions (IND, NDA/BLA) and respond to agency queries.
• Identify and manage consultants and vendors for pharmacometrics analyses.
• Collaborate on cross-functional teams applying MIDD principles.

Educación

PhD in pharmaceutical sciences

Herramientas

NONMEM

Monolix

Phoenix WinNonlin

R

GastroPlus

SimCYP

ADAPT

PK Sim

Descripción del empleo

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 visit www.jazzpharmaceuticals.com for more information.

Brief Description:

This position is responsible for leading efficient, innovative population PK, PK/PD, exposure-response plan, analysis, interpretation, and reporting to support international drug development programs. Working through cross-functional teams, this individual will lead the overall pharmacometrics strategy for multiple Jazz portfolio products, from research to registration and beyond.

Essential Job Functions:

Job Responsibilities

• Development of the pharmacometrics strategy of multiple programs
• Design, perform, interpret and report population PK, PK/PD and exposure-response analyses
• Provide hands-on population PK and PK/PD modeling and simulation support for development projects, e.g., dose selection and optimization
• Clinical study protocol design, data analysis/interpretation, and reporting of studies by preparing CSRs and various regulatory documents (INDs, NDA's, IB's, etc.). 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.
• Plan, prepare and review drug development plans and regulatory filings
• 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
• Identify and manage consultants and vendors supporting pharmacometrics analyses
• Effective participation on cross functional teams to ensure effective integration of Model Informed Drug Development (MIDD) principles

Required Knowledge, Skills, and Abilities

• PhD in pharmaceutical sciences, biomedical engineering, clinical pharmacology, or mathematical/statistical sciences with 5+ years of experience with clinical pharmacokinetic and pharmacokinetic- pharmacodynamic data analysis
• Strong understanding of clinical pharmacology and pharmacometrics principles and the drug development process
• Prior working experiences in performing modeling and simulation tasks using software for PK/PD analysis (eg, NONMEM, Monolix, Phoenix WinNonlin, R, GastroPlus, SimCYP, ADAPT, PK Sim, etc.)
• Experience in regulatory agency interactions is plus
• Ability to work both independently and collaboratively in a multidisciplinary team environment
• Ability to navigate and be successful in a fast-paced, highly matrixed work environment
• Excellent written and oral communication skills including good presentation skills
• Embody and model Jazz core values

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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: $164,000.00 - $246,000.00

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.