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Clinical Pharmacology Director

2 months ago

Work From Home, United Kingdom The RFT Group Full time
Job Title: Clinical Pharmacology Director

We are seeking a highly experienced Clinical Pharmacology Director to join our team at The RFT Group, a leading recruitment agency specializing in the biotechnology, pharmaceutical, and medical device sectors.

Job Summary:

The successful candidate will be responsible for leading clinical pharmacology and pharmacokinetics efforts, ensuring the scientific quality of clinical pharmacology studies, and providing expertise in regulatory interactions. This is a key role that will contribute to the development of our clients' products and services.

Key Responsibilities:
  • Lead clinical pharmacology and pharmacokinetics efforts, ensuring the scientific quality of clinical pharmacology studies.
  • Provide expertise in regulatory interactions, including providing leadership on all clinical pharmacology matters and support to project teams.
  • Ensure adherence to agreed timelines and budgets to ensure prompt and accurate execution of deliverables from clinical pharmacology studies and programs.
  • Oversee clinical pharmacology and pharmacokinetics consultants.
  • Presents data at scientific meetings and authors/reviews manuscripts for submission to peer-reviewed journals as needed.
  • Hands-on reporting, analysis, and interpretation of clinical study data.
  • Supporting and presenting at study level meetings, as required.
Requirements:
  • PhD or PharmD degree with emphasis in clinical pharmacology and experience with clinical pharmacology studies.
  • Several years of scientific, strategic, and operational experience in planning, executing, reporting, and publishing clinical PK/PD programs in CNS pharma.
  • Excellent understanding of ICH GCP and up-to-date on regulatory requirements.
  • Demonstrates good medical/scientific writing skills.
  • Depth of pharmacokinetics, modeling and simulation techniques, principles of pharmacodynamics and PKPD analysis, concepts related to ADME, and bioanalytical methodologies/related regulations.
  • Knowledge of principles of clinical data collection and reporting; EDC systems, Excel, etc. for data collection, analysis, and reporting.
  • Ability to critically analyze problems and provide creative solutions.
  • Scientific rigor in experimental design, study conduct, analysis, interpretation, and communication of results.
  • Contribute to the production and authoring of scientific documents with full attention to accuracy and consistency.