Senior Pharmacokinetic Scientist

Celerion; Canada; Remote; CAD 80,000 - 100,000; Full time

Job summary

Join a forward-thinking company as a Senior Pharmacokinetic Scientist, where you will leverage your expertise in clinical pharmacology to conduct vital data analyses and contribute to innovative drug development. This role offers the opportunity to work remotely in Canada or the United States, allowing you to collaborate with a talented team dedicated to advancing clinical research. You will be at the forefront of pharmacokinetic and pharmacodynamic studies, preparing essential reports and regulatory documents while mentoring junior staff. If you're passionate about making a difference in the pharmaceutical industry, this is the perfect opportunity for you.

Qualifications

• Master's or PhD in a related field with 4+ years of experience required.
• Solid knowledge of clinical pharmacology and pharmacokinetics essential.

Responsibilities

• Conduct pharmacokinetic data analysis and interpret study results.
• Prepare regulatory documents and assist in clinical trial protocols.

Skills

Clinical Pharmacology

Pharmacokinetics

Pharmacodynamics

Problem-solving

Communication Skills

Education

Master's or PhD in Biology-focused Sciences

Tools

Phoenix WinNonlin

Job description

Celerion 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 pharmacokinetic data analysis, provide scientific interpretation of study results, perform clinical report writing, and independently handle interactions with clients.

Essential Functions:

1. Conduct pharmacokinetic data analysis, provide scientific interpretation of study results, perform clinical report writing, and independently handle interactions with clients.
2. 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.
3. Perform PK analyses independently on a variety of complex studies.
4. Perform PD analyses independently.
5. Interpret PK, PD and statistical results and findings independently.
6. Perform QC reviews as assigned.
7. Write and review reports as assigned.
8. Prepare PK/PD data/report files for electronic filing of projects for submission to regulatory agencies.
9. Maintain and file all supportive documentation pertaining to the study and ensure proper archiving of projects.
10. Contribute to regulatory documents (e.g. NDA, ANDA).
11. Perform and/or oversee drafting of pharmacometric analysis plans, perform analyses and write pharmacometric reports.
12. Represent the client in regulatory interactions or client internal meetings.
13. Prepare internal presentations.
14. Interact with internal departments (e.g. bioanalytical, project management, business development, etc.).
15. Assist in the preparation of clinical pharmacology trial protocols.
16. Publish manuscripts in PK/PD area.
17. 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.