Canada onlyCelerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster.
We are looking for a full-time Senior Pharmacokinetic Scientist to join our Clinical Pharmacology team. This role may be based remotely in the United States or Canada.
The Senior Pharmacokinetic Scientist will conduct pharamacokinetic data analysis, provide scientific interpretation of study results, perform clinical report writing, and independently handle interactions with clients.
Essential Functions:
The Senior Pharmacokineticist I will conduct pharamacokinetic data analysis, provide scientific interpretation of study results, perform clinical report writing, and 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
Requirements
- Master’s or PhD degree in a biology-focused sciences related field with 4+ years of related experience required*
- Solid knowledge of clinical pharmacology, pharmacokinetics, and pharmacodynamics required
- Competence in performing noncompartmental pharmacokinetic analysis with software applications such as Phoenix WinNonlin
- Familiarity with theory and application (including software use) of non-linear mixed-effect modeling and/or physiologically-based pharmacokinetic modeling is an asset
- Excellent organization and problem solving skills required
- Excellent oral and written skills (English language) required
Celerion Values: Integrity Trust Teamwork Respect
Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.
United States
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