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Company

ClinChoice · 6 hours ago

Senior/Principal Pharmacokinetics Scientist - (Fulltime-Remote)

Jersey City, NJ

Full-time

Remote

Senior Level, Lead/Staff

3+ years exp

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Responsibilities

Significant experience leading study concept and protocol design, authoring clinical pharmacology development plans, and creating modeling and simulation plans.

Conduct PK-PD, Pop PK-PD, and related analyses to support clinical trials, ensuring accurate data interpretation and integration into regulatory filings, clinical publications, and presentations.

Provide technical expertise and support in the use of standard PK and PD data analysis software, including Phoenix WinNonlin, NLME, R/R Studio, Monolix, NONMEM, and similar tools.

Collaborate closely with clients to understand project needs, provide expert guidance on clinical pharmacology, and deliver high-quality outcomes.

Prepare and review comprehensive PK/PD analysis reports, ensuring clear and precise communication of study results to clients and stakeholders.

Apply significant knowledge of pharmaceutical regulatory requirements related to clinical pharmacology to ensure compliance and support regulatory submissions.

Work effectively in cross-functional teams, including bioanalytical scientists, biostatisticians, and clinical operations, to ensure seamless project execution.

Provide mentorship and leadership to junior pharmacologists, contributing to the development and implementation of best practices within the team.

Stay current with advancements in clinical pharmacology, applying the latest knowledge to enhance project outcomes and client satisfaction.

Qualification

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PharmacokineticsPharmacodynamicsClinical pharmacologyModelingSimulationPhoenix WinNonlinNLMER/R StudioMonolixNONMEMData analysisRegulatory complianceTherapeutic areas experienceCRO experienceRelevant certificationsProject management

Required

PhD in pharmaceutical sciences, pharmacology, life sciences, clinical pharmacology, pharmacokinetics, or a related discipline, with at least 3 years of relevant research or clinical experience in clinical pharmacology and pharmacokinetic-pharmacodynamic modeling within the pharmaceutical or biotechnology industry.

PharmD in a relevant discipline with a minimum of 5 years of experience in clinical pharmacology and PK/PD modeling and simulation.

Alternatively, a Master's degree in a related field with at least 7 years of relevant experience in Clinical Pharmacology and Modeling & Simulation.

Robust knowledge of pharmacokinetics, pharmacodynamics, translational sciences, and PK/PD data analysis.

Hands-on experience and expertise with standard PK and PD data analysis software such as Phoenix WinNonlin, NLME, R/R Studio, Monolix, and NONMEM.

Strong communication and organizational skills, with the ability to present complex data to both scientific and non-scientific audiences.

Proven ability to manage multiple projects simultaneously and work effectively in a dynamic, client-oriented environment.

Preferred

Experience in working across a variety of therapeutic areas.

Prior experience working in a CRO setting is highly desirable.

Relevant certifications in clinical pharmacology or related disciplines are a plus.

Company

ClinChoice

Glassdoor

3.7

ClinChoice is a full-service global clinical CRO dedicated to offering high-quality, efficient and flexible solutions to pharmaceutical, biotechnology, medical device, and consumer products clients worldwide.

Founded in 1995

Shanghai, Shanghai, CHN

1001-5000 employees