Sr Pharmacokineticist - Cambridge, United Kingdom - Thermo Fisher Scientific

Thermo Fisher Scientific
Thermo Fisher Scientific
Verified Company
Cambridge, United Kingdom

1 week ago

Tom O´Connor

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Tom O´Connor

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Description
Our team of colleagues in clinical research services are at the forefront of getting cures to market.

We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world's most challenging health concerns.

Our Clinical Research team, who powers our PPD clinical research portfolio, are part of our leading global contract research organization (CRO).

PPD's mission is to improve health. It starts as an idea to find a cure. It becomes a life saved.

All in-between, it's you We know that meaningful results not only require the right approach, but also the right people.

We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams.

We are passionate about being data and technically agile and driving enhanced value for our clients and patients.

Determined to improve patient health, we help PPD provide industry-leading statistical, programming and clinical pharmacology contributions through global delivery, consistent quality adherence and scientific insight.


As a Senior Pharmacokineticist, you will oversee the clinical pharmacology and pharmacokinetic aspects of clinical trials from design, through analysis and reporting.

Acts as lead pharmacokineticist on large or complex projects.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team.

We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.


Summarized Purpose:
Oversee the clinical pharmacology and pharmacokinetic aspects of clinical trials from design, through analysis and reporting. Acts as lead pharmacokineticist on large or complex projects.

Designs, analyzes and interprets pharmacokinetic, bioavailability, bioequivalence and pharmacodynamic clinical trials through analysis, interpretation, and review of pharmacokinetic and pharmacodynamic results.


Essential Functions:

  • Serves as Lead Pharmacokineticist or Pharmacokinetic Project Lead on large pharmacokinetic projects and/or development programs.
  • Manages pharmacokinetic project activities and timelines.
  • Serves as senior reviewer on pharmacokinetic projects.
  • Reviews clinical pharmacology deliverables and documents related to project activities.
  • Mentors Pharmacokineticist and Clinical Pharmacology staff on project activities.
  • Assists in staff training and professional development.
  • Participates in clinical pharmacology initiatives.
  • Develops and revises department SOPs and guidelines for the conduct, analysis and reporting of clinical pharmacology and pharmacokinetic trials.
  • Assists senior management team on departmental decision making, bid and marketing activities, recruitment, and process improvement.
  • Keeps updates on the regulatory guidelines with respect to pharmacokinetics and related disciplines and current trends.
  • Prepare/review pharmacokinetic reports and regulatory documents for submission.

Education and Experience:

  • Bachelor's degree or equivalent and relevant formal academic / vocational qualification
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years) or equivalent combination of education, training, and experience
  • Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.

Knowledge, Skills and Abilities:

  • Strong theoretical background in pharmacokinetics and knowledge of the drug development process
  • Knowledgeable of regulatory guidelines relevant to clinical pharmacology and pharmacokinetics areas of the drug development
  • Handson experience in performing pharmacokineticspharmacodynamics modeling and simulation of clinical trial data is preferred
  • Good understanding of statistical methodology required in clinical pharmacology and pharmacokinetic trials
  • Proven management skills, as shown through management of multiple projects
  • Strong organizational skills across multiple complex projects, managing own and project team work loads, and the ability to adapt and adjust to changing priorities
  • Excellent written and verbal communications skills
  • Demonstrated initiative and motivation
PPD is now part of Thermo Fisher Scientific.

As the world leader in serving science, our Mission is to enable our customers to make the world healthier, cleaner and safer.

We are excited about the opportunities this combination brings to enhance our comprehensive end-to-end offering, enabling customers to move rapidly from scientific idea to approved medicine.


Our 4i Values:
Integrity - Innovation - Intensity - Involvement

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