Principal Pharmacokinetics Scientist -(Permanent Remote role)

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.