Senior Pharmacokinetic Scientist I

This position is accountable for providing strategic direction and vision to primarily support non-compartmental pharmacokinetic (PK) or pharmacodynamic (PD) data analysis and reporting for clinical trial designs, compound development plans, and regulatory submissions. This position may also on occasion provide strategic direction and vision to support advanced individual and population PK/PD modeling and simulations. The incumbent will work closely with multidisciplinary study teams, which may include medical/clinical staff, Study Data Managers, other PK Scientists, Pharmacometric Scientists/Consultants, Biostatisticians, Medical Writers, and Project Managers.

Reports to the Associate Director (or above), Clinical Pharmacology and Drug Development, and works directly with Everest and project sponsor team members, fostering cooperative working relationships.
1. Conduct PK/PD data analysis using non-compartmental analysis. May also provide support in the conduct of advanced PK/PD modeling and simulations (individual and population) and/or disease modeling using software such as Phoenix WinNonlin and Non-linear Mixed Effect (NLME), Monolix, NONMEM, and R, etc.
2. Apply and/or provide strategic direction and vision on PK/PD data analysis to support clinical trial designs, compound development plans, and regulatory submissions.
3. Generate predictive simulations and provide input into trial protocol development.
4. Provide mentorship and oversight to PK Scientists Level I and II.
5. Provide input into clinical trial Statistical Analysis Plans (and mock shells) including PK/PD analysis components or author standalone PK/PD Analysis Plans (including PK/PD mock shells).
6. Author and/or review PK/PD related documents or reports such as PK Study Reports, ensuring appropriate and accurate interpretation of PK and PK-related study endpoints.
7. Contribute to the clinical pharmacology sections of relevant documents, such as clinical study protocols, clinical study reports, Investigator's Brochures, briefing documents, and Investigational New Drug (IND)/New Drug Application (NDA) and/or Abbreviated New Drug Application (ANDA) submissions.
8. May work with regulatory submission personnel to provide PK/PD data in support of regulatory communications and presentations as needed.
9. May represent the company on PK/PD issues at appropriate scientific meetings, for regulatory issues, and with clinical trial clients.
10. Participate in the development and maintenance of, and adhere to, divisional Standard Operating Procedures (SOPs) and guidelines, and to therapeutic area specific standards and conventions.
11. Keep current with the general requirements or guidelines issued by the pharmaceutical drug trial regulators and ICH.
12. Plan and carry out professional development.

LEVEL OF ACCOUNTABILITY:

The effectiveness and efficiency of performance of this position has a direct bearing on the smooth operation of Everest and the quality of deliverables by Everest project teams. Effective job performance can have a major impact on the clients' confidence in Everest's capabilities. The position will impact approximately 5-10 projects being conducted at any given point in time.

KEY EQUIPMENT/SOFTWARE USED:
1. WinNonlin or other relevant pharmacometric software (including NLME and Monolix).
2. Microsoft Word, PowerPoint, Excel, Project, Outlook
3. SAS and sample size calculation software
4. SASView (Statistical Analysis System).
5. Other software as may be required.

1. Advanced degree, Ph.D. or M.Sc. in Clinical Pharmacology (including Pharmacokinetics, Pharmacodynamics), Pharmacy, Biopharmaceutics, or related field.
2. At least 4 to 6 years' experience as a PK Scientist or related role in the pharmaceutical clinical trial environment.
3. Experience in multiple therapeutic areas and Phase I through IV clinical trials an asset.
4. Proficient in using WinNonlin, or other relevant pharmacokinetic software for non-compartmental analysis, PK/PD analysis, and modeling.
5. Familiarity with SAS is preferred (or willingness to learn and master SAS skills).
6. Excellent understanding of clinical trials and common clinical trial statistical analysis methods.
7. Skilled in scientific writing and data interpretation
8. Demonstrated ability to understand PK results; able to communicate effectively, orally and in writing.
9. Demonstrated ability for logical thinking, vision, and creativity necessary to function effectively with a large degree of independence and little supervision.
10. Experience with client relationship management.
11. Ability to multi-task, manage multiple projects with competing and aggressive timelines.
12. Excellent interpersonal and teamwork skills; detail-oriented, customer- and quality-focused.
13. Well organized and able to work independently.
14. Strong understanding of fundamental PK and statistical principles.

Everest Clinical Research ("Everest") is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.

Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest's headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan.

Everest also recently completed the acquisition of August Research. August Research is a European CRO that provides Clinical Operations and Pharmacovigilance services to a wide variety of pharmaceutical and biotechnology clients. The Company has worked on over 120 projects for Phase I-IV clinical trials across multiple therapeutic areas including cardiovascular, infectious disease, oncology and rare disease. The acquisition of August Research establishes a European footprint for Everest to provide full-service offerings to its pharmaceutical, biotechnology and medical devices clients, and other operational capabilities through the Company's substantive experience and infrastructure across 14 countries in Western and Eastern Europe.

Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients' needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.

Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that's us…that's Everest.