2 дня назад
Principal Pharmacokinetics Scientist
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Principal Pharmacokinetics Scientist (Clinical Pharmacology/PK-PD Modeling): Designing and analyzing clinical pharmacology studies, PK/PD models, and regulatory submission materials with an accent on pharmacokinetic-pharmacodynamic analysis, modeling software, and protocol development. Focus on leading study concepts, integrating complex data into regulatory filings, mentoring pharmacologists, and guiding cross-functional client projects.
Location: United States; permanent remote role
Company
is a global full-service contract research organization supporting pharmaceutical, biotechnology, medical device, and consumer health companies with clinical development and functional solutions.
What you will do
- Lead study concept development, protocol design, clinical pharmacology development plans, and modeling and simulation plans.
- Conduct PK-PD, population PK-PD, and related analyses supporting clinical trials, regulatory filings, publications, and presentations.
- Use Phoenix WinNonlin, NLME, R/RStudio, Monolix, NONMEM, and similar PK/PD analysis tools.
- Collaborate with clients and cross-functional teams, including bioanalytical scientists, biostatisticians, and clinical operations.
- Prepare and review PK/PD analysis reports and provide expert guidance on clinical pharmacology and regulatory requirements.
- Mentor junior pharmacologists and contribute to clinical pharmacology best practices.
Requirements
- PhD in pharmaceutical sciences, pharmacology, life sciences, clinical pharmacology, pharmacokinetics, or a related field with at least 3 years of relevant experience; or PharmD with at least 5 years; or a relevant Master’s degree with at least 7 years.
- Relevant experience in clinical pharmacology and pharmacokinetic-pharmacodynamic modeling and simulation within the pharmaceutical or biotechnology industry.
- Strong knowledge of pharmacokinetics, pharmacodynamics, translational sciences, and PK/PD data analysis.
- Hands-on expertise with Phoenix WinNonlin, NLME, R/RStudio, Monolix, NONMEM, or similar software.
- Strong communication and organizational skills, including the ability to present complex data to scientific and non-scientific audiences.
- Ability to manage multiple projects in a dynamic, client-oriented environment.
Nice to have
- Experience across multiple therapeutic areas.
- Prior experience in a CRO setting.
- Certifications in clinical pharmacology or a related discipline.
Culture & Benefits
- Permanent remote work with a collaborative, quality-focused one-team culture.
- Professional development supported by continuous training and mentorship.
- Work with projects across pharmaceutical, biotechnology, medical device, and consumer health portfolios.
- Equal opportunity workplace focused on diversity and inclusion.
Hiring process
- Submit a CV and receive an application acknowledgement.
- Selected candidates are invited to a phone interview as the first step.
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