Associate Director, Quantitative Clinical Pharmacology

Company: Jazz Pharmaceuticals
Location: Palo Alto
Posted on: October 4, 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 PKPD modeling scientist 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 applying various modeling techniques in drug discovery and development to drive the development of new molecular entities into a life-changing medicine. The candidate should have broad PKPD modeling expertise and work in a team environment to support drug discovery and development projects. It is not required but a plus to have experiences in regulatory interactions, such as IND and NDA filings, as a QCP lead in discovery and development projects.

Key responsibilities/core job functions:

• Represent QCP function in cross functional discovery and development project teams to develop model-based drug development strategy in collaboration clinical pharmacology/DMPK colleagues
• Provide hands-on modeling and simulation support for development projects, including but not limited to, population PK analysis, mechanistic PKPD modeling, exposure response analysis for efficacy/safety endpoints/biomarker data, dose selections for confirmatory trials.
• Monitor modeling and simulation projects in contract research organizations and provide technical support and critical reviews to the population PK/PD reports.
• 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 the drug development (model-based drug development).

Required Knowledge, Skills, and Abilities

• Hands-on experiences in PKPD, PBPK, or QSP modeling is required for this position.
• Proficient in computer programs for population PKPD, such as, NONMEM or Monolix or other programs, and familiar with other modeling and statistical tools, R/SAS, MetaLab, WinNonlin, GastroPlus, SimCYP, PK-Sim, ADAPT, etc.
• Possess thorough theoretical and practical understanding of drug discovery and development
• Has sufficient clinical pharmacology/DMPK knowledge.
• Ability to prioritize and manage multiple projects and activities while meeting tight deadlines.
• Strong written and oral communication skills.
• Ability to work independently and collaboratively in a multidisciplinary team environment.

Required/Preferred Education and Licenses

• Master’s degree in pharmaceutical sciences, clinical pharmacology, or relevant mathematical/statistical/biomedical engineering/bioinformatics/biological field, with more than 8 years of academic/industry experience in clinical pharmacology, PKPD, or QSP modeling is required
• Ph.D. or equivalent doctoral degree in pharmaceutical sciences, clinical pharmacology, or relevant mathematical/statistical/biomedical engineering/bioinformatics/biological field, with more than 5 years of industry/ industry + academic experience in clinical pharmacology, PKPD, or QSP modeling is required

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.

Keywords: Jazz Pharmaceuticals, Palo Alto , Associate Director, Quantitative Clinical Pharmacology, Other , Palo Alto, California