[Hiring] PK Scientist II @Everest Clinical Research

Role Description

To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as PK Scientist II for our Toronto/Markham, Ontario, Canada on-site location, or remotely from a home-based office anywhere in Canada in accordance with our Work from Home policy.

Responsibilities

• Conduct PK/PD data analysis using non-compartmental analysis.
• May also provide support in the conduct of PK/PD modeling and simulations (individual and population) using software such as Phoenix® WinNonlin®, Non-linear Mixed Effect (NLME), Monolix, and R, etc.
• Apply learned experiences and knowledge to more complex tasks as assigned.
• Apply strategic direction and vision on PK/PD data analysis to support clinical trial designs, compound development plans, and regulatory submissions.
• Generate predictive simulations and provide input into trial protocol development.
• Provide input into clinical trial Statistical Analysis Plans (and mock tables, listings, and graphs [TLGs] shells) including PK/PD analysis components or author standalone PK/PD Analysis Plans (including PK/PD mock shells).
• Author and/or review PK/PD related documents or reports such as protocols, PK Study Reports, ensuring appropriate and accurate interpretation of PK and PK/PD-related study endpoints.
• 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.
• May work with regulatory affairs personnel to provide PK/PD data in support of regulatory communications and presentations as needed.
• Participate in the maintenance of, and adhere to, divisional Standard Operating Procedures (SOPs) and guidelines, and to therapeutic area specific standards and conventions.
• Keep current with the general requirements or guidelines issued by the pharmaceutical drug trial regulators and ICH.
• Plan and carry out professional development.

Qualifications

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

Benefits

• Robust benefits package to support your health, well-being, and growth.
• Medical, dental, and vision coverage.
• Life & AD&D insurance.
• Short- and long-term disability.
• Tuition reimbursement.
• Fitness reimbursement.
• Employee assistance program (EAP).
• Pension plan.
• Generous paid time off and sick leave.
• Opportunity to earn a performance-based bonus.

Company Description

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.

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 is known in the industry for its high-quality deliverables, superior customer service, and flexibility in meeting clients’ needs.