Job Title: Senior Pharmacokinetic Scientist I
Job Location: London, UK
Job Location Type: Hybrid
Job Contract Type: Full-time
Job Seniority Level: Mid-Senior level
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.
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 a Senior Pharmacokinetic Scientist in England / United Kingdom with opportunities to work remotely in accordance with our Work from Home policy.
POSITION OBJECTIVE:
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.
KEY RESPONSIBILITIES:
* 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).
* Apply and/or provide strategic direction 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 mentorship and oversight to PK Scientists Level I and II.
* Provide input into clinical trial Statistical Analysis Plans including PK/PD analysis components.
* Author and/or review PK/PD related documents or reports such as PK Study Reports.
* Contribute to the clinical pharmacology sections of relevant documents.
* May work with regulatory submission personnel to provide PK/PD data in support of regulatory communications.
* May represent the company on PK/PD issues at appropriate scientific meetings.
* Participate in the development and maintenance of, and adhere to, divisional Standard Operating Procedures (SOPs).
* 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, Pharmacy, Biopharmaceutics, or related field.
* At least 4 to 6 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 an asset.
* Proficient in using WinNonlin or other relevant pharmacokinetic software.
* Familiarity with SAS is preferred.
* Excellent understanding of clinical trials and common clinical trial statistical analysis methods.
* Skilled in scientific writing and data interpretation.
* Demonstrated ability to understand PK results and communicate effectively.
* Experience with client relationship management.
* Ability to multi-task and manage multiple projects with competing timelines.
* Excellent interpersonal and teamwork skills; detail-oriented, customer- and quality-focused.
* Strong understanding of fundamental PK and statistical principles.
We thank all interested applicants; however, only those selected for an interview will be contacted.
Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities.
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