Senior Manager, Quantitative Clinical Pharmacology

Company: Jazz Pharmaceuticals
Location: Palo Alto
Posted on: July 22, 2021

Job Description:

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.

 Jazz is looking for an experienced data processing and modeling expert to join the quantitative clinical pharmacology (QCP) group to discover and develop life-changing medicines for patients. As a QCP scientist, the candidate should have extensive knowledge on assembling and validating datasets for modeling and simulation work and conducting basic PKPD assessment, such as noncompartmental analysis, and exposure-response assessment. Experience in clinical pharmacology/DMPK is a plus but not a requirement. The candidate should have hands-on experience in processing PK data and performing PKPD modeling and be able to work in a team environment to support drug discovery and development projects.

Key responsibilities/core job functions:

• Assembling datasets for population PKPD analysis and analyze PK data using non-compartmental analysis;
• Provide hands-on modeling and simulation support for development projects, e.g. mechanistic PKPD modeling, exposure response analysis for efficacy/safety endpoints/biomarker data, or dose selections for confirmatory trials.
• Represent QCP function in cross functional discovery and development project teams to develop model-based drug development strategy in collaboration clinical pharmacology/DMPK colleagues
• Write scientific reports for modeling and simulation results conducted in house and review modeling analysis reports from CROs.
• Represent QCP in cross-functional teams to explain QCP strategy and study outcomes.
• Champion on problem solving using modeling and simulation techniques to drive drug development (model-based drug development).

Qualification

• MS/MA in mathematical/statistical sciences, biomedical engineering or pharmaceutical sciences with a minimum of 5 years industry working experiences; Pharm D, or PhD in mathematical/ statistical sciences, biomedical engineering, or pharmaceutical sciences with minimum at least 3 years academic or industry working experiences;
• Hands-on experiences in PK data analysis using non-compartmental analysis is required for this position.
• Proficient in modeling and statistical tools such as R and SAS;
• Prior experience in performing modeling and simulation tasks using NONMEM/Monolix, MetaLab, WinNonlin, GastroPlus, SimCYP, PK-Sim, or ADAPT is a plus but not a requirement
• Possess thorough theoretical and practical understanding of drug discovery and development
• Strong written and oral communication skills
• Ability to work independently and collaboratively in a multidisciplinary team environment.

Location

Palo Alto, California; Philadelphia, Pennsylvania

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.

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