Senior Pharmacokinetic Scientist

Summary

Join Celerion's Clinical Pharmacology team as a full-time Senior Pharmacokinetic Scientist! This remote position (US or Canada) involves conducting pharmacokinetic data analysis, interpreting study results, writing clinical reports, and managing client interactions. You will perform PK and PD analyses, QC reviews, report writing, and contribute to regulatory documents. The role may include staff management. This position requires a Master's or PhD in a biology-focused science with 4+ years of experience and strong skills in pharmacokinetics and pharmacodynamics.

Requirements

• Master’s or PhD degree in a biology-focused sciences related field with 4+ years of related experience
• Solid knowledge of clinical pharmacology, pharmacokinetics, and pharmacodynamics
• Competence in performing noncompartmental pharmacokinetic analysis with software applications such as Phoenix WinNonlin
• Excellent organization and problem solving skills
• Excellent oral and written skills (English language)

Responsibilities

• Conduct pharmacokinetic data analysis
• Provide scientific interpretation of study results
• Perform clinical report writing
• Independently handle interactions with clients
• May be responsible for staff management in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems; development and coaching of employees
• Perform PK analyses independently on a variety of complex studies
• Perform PD analyses independently
• Interpret PK, PD and statistical results and findings independently
• Perform QC reviews as assigned
• Write and review reports as assigned
• Prepare PK/PD data/report files for electronic filing of projects for submission to regulatory agencies
• Maintain and file all supportive documentation pertaining to the study and ensure proper archiving of projects
• Contribute to regulatory documents (e.g. NDA, ANDA)
• Perform and/or oversee drafting of pharmacometric analysis plans, perform analyses and write pharmacometric reports
• Represent the client in regulatory interactions or client internal meetings
• Prepare internal presentations
• Interact with internal departments (e.g. bioanalytical, project management, business development, etc.)
• Assist in the preparation of clinical pharmacology trial protocols
• Publish manuscripts in PK/PD area
• Lead and/or participate in functions required to ensure success of department or market segment team

Preferred Qualifications

Familiarity with theory and application (including software use) of non-linear mixed-effect modeling and/or physiologically-based pharmacokinetic modeling