Principal Pharmacokinetics Scientist

Jobtailor; Deutschland; Remote; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

Jobtailor in Germany seeks an experienced lead clinical pharmacologist to design study concepts and PK/PD modeling strategies for regulatory submissions.

You will collaborate with clients and cross-functional teams, mentor junior staff, and translate complex PK/PD data into publications and filings.

Qualifikationen

• PhD/PharmD/Master with clinical pharmacology and PK/PD modeling experience.
• Experience in pharmaceutical/biotech industry and modeling & simulation.
• Strong knowledge of PK/PD and translational sciences.
• Hands-on modeling tools and data analysis experience.

Aufgaben

• Lead study concept and protocol design.
• Author development and modeling plans.
• Conduct PK-PD, Pop PK-PD analyses for trials.
• Interpret data for regulatory filings and publications.
• Mentor junior pharmacologists and implement best practices.
• Collaborate with clients and cross-functional teams.

Kenntnisse

PK/PD Modeling

Clinical pharmacology

Data analysis

Regulatory interpretation

Mentoring

Ausbildung

PhD in pharmaceutical sciences

PharmD

Master's degree in related field

Tools

Phoenix WinNonlin

NLME

R/R Studio

Monolix

NONMEM

Jobbeschreibung

• Lead study concept and protocol design
• Author clinical pharmacology development plans and create modeling and simulation plans
• Conduct PK-PD, Pop PK-PD, and related analyses supporting clinical trials
• Interpret and integrate data into regulatory filings, clinical publications, and presentations
• Provide technical expertise using PK/PD data analysis software
• Collaborate with clients and cross-functional teams to deliver project outcomes
• Prepare and review PK/PD analysis reports
• Apply pharmaceutical regulatory requirements to support compliant submissions
• Mentor junior pharmacologists and implement team best practices
• Stay current with clinical pharmacology advancements

Requirements

• 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 Phoenix WinNonlin, NLME, R/R Studio, Monolix, and NONMEM
• Strong communication and organizational skills, with the ability to present complex data to scientific and non-scientific audiences
• Proven ability to manage multiple projects simultaneously in a dynamic, client-oriented environment
• Preferred: experience across a variety of therapeutic areas
• Preferred: prior CRO experience
• Relevant certifications are a plus

Core Competencies

Demonstrates expertise in clinical pharmacology, including PK/PD modeling and simulation, with a strong ability to interpret data for regulatory submissions and publications. Proven experience in mentoring and collaborating with cross-functional teams to achieve project goals in a dynamic environment.

Highest-signal resume keywords

• PhD In Pharmaceutical Sciences
• Clinical Pharmacology Experience
• PK/PD Modeling And Simulation
• Phoenix WinNonlin Expertise
• Strong Communication Skills

ATS Optimization Keywords

Hard Skills

• Pharmacokinetics
• Pharmacodynamics
• Translational Sciences
• PK/PD Data Analysis
• Modeling And Simulation

Soft Skills

• Organizational Skills
• Project Management
• Mentoring

Industry Keywords

• Pharmaceutical Industry
• Biotechnology Industry
• CRO Experience
• Therapeutic Areas

Tools & Technologies

• Phoenix WinNonlin
• NLME
• R/R Studio
• Monolix
• NONMEM