Senior/Principal Pharmacokinetics Scientist - (Fulltime-Remote)
Jersey City
Senior/Principal Pharmacokinetics Scientist - (Fulltime-Remote)
at ClinChoice (View all jobs)United States
ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a Senior/Principal Pharmacokinetics Scientist in the United States.The ideal candidate will possess a deep understanding of pharmacokinetics (PK) and pharmacodynamics (PD) theory and practice and will play a key role in the design, execution, and analysis of clinical pharmacology studies and other projects involving PK/PD.
This position requires strong leadership in study concept development, protocol design, and the ability to work collaboratively with both internal teams and external clients.
Join our team: you can be part of making a difference in peoples' lives and experience a fulfilling and rewarding career!
Key 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.
Qualifications:
- 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 Qualifications:
- 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.
#LI-TT1 #LI-Remote #Senior #Contract
Bridgewater (NJ), 32 mi from Jersey City
with a multidisciplinary team of scientists focused on the development, validation, and execution of various bioanalytical assays related to pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity testing.
Responsibilities:
• Develop various types of ELISA...
Princeton (NJ), 41 mi from Jersey City
using appropriate equipment and techniques in areas of biology, pharmacokinetics, simple chemistry, microbiology, and immunology.
• Prepare animals and samples for testing, observe tests, and detect and report responses.
• Perform support duties...
Hackensack (NJ), 11 mi from Jersey City
and requests of other healthcare professionals.
• Actively participates in pharmacy clinical initiatives including, but not limited to, renal dose adjustments, IV to PO conversions, pharmacokinetic dosing, antibiotic stewardship, opioid stewardship, etc...