Pharma Medica Research (PMRI) is a Contract Research Organization that strive for innovation and original solutions in highly regulated and competitive industry. If you strive for innovation and original thinking you will be the perfect candidate to be part of an inclusive, adaptable, and forward-thinking organization. Currently we are looking for a Senior Pharmacokinetic Scientist to join our team!
Position Summary
The Senior Pharmacokinetic Scientist performs pharmacokinetic/pharmacodynamic analyses of data generated through clinical studies; mentors and trains junior staff in the PK department; assists in the design of pharmacokinetic and comparative bioavailability studies; reviews study protocols, provides support in statistical analyses, as well as prepares/reviews study reports. This position reports to the Vice President, Scientific Affairs and/or designate.
Duties and Responsibilities
Duties include, but are not necessarily limited to:
- Perform pharmacokinetic analysis of data generated in Phase I-IV clinical studies.
- Perform pharmacokinetic and statistical analysis of data generated through comparative bioavailability trials.
- Prepare study designs.
- Review study protocols and study reports for scientific content, data accuracy and compliance with Canadian, American and European guidelines.
- Ensure timely delivery of accurate study reports to Pharma Medica Research Inc. (PMRI) clients.
- Assist in the preparation and review of Statistical Analysis Plans (SAPs) and mock tables, listings and figures.
- Provide scientific support to other departments within PMRI.
- Perform pharmacokinetic and/or pharmacodynamic modeling, as required.
- Mentor and train junior staff in the PK department.
- Responsible for acquiring and maintaining knowledge of national and international regulatory guidelines.
- Assist in the review of study documentation and in the preparation of an action plan for regulatory inspections.
- Responsible for developing, writing, implementing and maintaining Standard Operating Procedures (SOPs) related to pharmacokinetics, biometrics and report writing activities in co-operation with the Vice President, Scientific Affairs, and senior management.
- Attendance at selected scientific and commercial meetings and exhibitions where you will assist PMRI personnel in the marketing of PMRI services.
- Other duties as required.
Qualifications
- M.Sc. in Pharmacokinetics or Pharmacology and experience in the design and conduct bioavailability and bioequivalence studies with 3 - 5 years of experience.
- High proficiency in PK software (e.g. Phoenix WinNonlin®)
- User-level knowledge of statistical software (e.g. SAS®).
- Team player
- Excellent verbal and written communications skills
- Ability to work both independently and as a team member
If you're looking for an exciting place to work, apply today!