Senior Pharmacokinetic Scientist I
Senior Pharmacokinetic Scientist I
Posted on :
20-01-2025
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Job Description
Job Title: Senior Pharmacokinetic Scientist I
Job Location: London UK
Job Location Type: Hybrid
Job Contract Type: Fulltime
Job Seniority Level: MidSenior level
Everest Clinical Research (“Everest”) is a fullservice contract research organization (CRO) providing a broad range of expertisebased clinical research services to worldwide pharmaceutical biotechnology and medical device industries. We serve some of the bestknown 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 fullservice 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 IIV 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 fullservice 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 customerfocus is our tradition flexibility is our strength…that’s us…that’s Everest.
To drive continued success in this exciting clinical research field we are seeking committed skilled and customerfocused 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 noncompartmental 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.
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 510 projects being conducted at any given point in time.
KEY EQUIPMENT/SOFTWARE USED:
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 and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.
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 fullservice 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 IIV 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 fullservice 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 customerfocus is our tradition flexibility is our strength…that’s us…that’s Everest.
To drive continued success in this exciting clinical research field we are seeking committed skilled and customerfocused 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 noncompartmental 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.
- Conduct PK/PD data analysis using noncompartmental 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 Nonlinear Mixed Effect (NLME) Monolix NONMEM and R etc.
- Apply and/or provide 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 mentorship and oversight to PK Scientists Level I and II.
- 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).
- Author and/or review PK/PD related documents or reports such as PK Study Reports ensuring appropriate and accurate interpretation of PK and PKrelated 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 submission personnel to provide PK/PD data in support of regulatory communications and presentations as needed.
- May represent the company on PK/PD issues at appropriate scientific meetings for regulatory issues and with clinical trial clients.
- 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.
- Keep current with the general requirements or guidelines issued by the pharmaceutical drug trial regulators and ICH.
- Plan and carry out professional development.
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 510 projects being conducted at any given point in time.
KEY EQUIPMENT/SOFTWARE USED:
- WinNonlin or other relevant pharmacometric software (including NLME and Monolix).
- Microsoft Word PowerPoint Excel Project Outlook.
- SAS and sample size calculation software.
- SASView (Statistical Analysis System).
- Other software as may be required.
- Advanced degree Ph.D. or M.Sc. in Clinical Pharmacology (including Pharmacokinetics Pharmacodynamics) 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 for noncompartmental analysis PK/PD analysis and modeling.
- Familiarity with SAS is preferred (or willingness to learn and master SAS skills).
- 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; 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.
- Ability to multitask manage multiple projects with competing and aggressive timelines.
- Excellent interpersonal and teamwork skills; detailoriented customer and qualityfocused.
- Well organized and able to work independently.
- 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 and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.
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Employment Type
Full Time
Key Skills
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