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Director of Clinical Pharmacology

2 months ago

London, Greater London, United Kingdom The RFT Group Full time
Job Description

Job Title: Director of Clinical Pharmacology

Company: The RFT Group

Location: Ireland or UK

Job Type: Full-time

Industry: Biotechnology

Job Category: Clinical Research

Job Description:

Job Summary

We are seeking an experienced Director of Clinical Pharmacology to join our team at The RFT Group. As a key member of our Clinical Science team, you will be responsible for overseeing clinical pharmacology and pharmacometrics activities, ensuring the scientific quality of clinical pharmacology studies, and providing leadership on all clinical pharmacology matters.

Key Responsibilities
  • Provide leadership on all clinical pharmacology matters and support to project teams.
  • Responsible for scientific quality of clinical pharmacology studies: design, implementation, analysis, interpretation, reporting, and regulatory submission.
  • Integrate clinical pharmacology knowledge with a broad understanding of and collaboration with related disciplines such as clinical, statistics, regulatory, nonclinical ADME, toxicology to support and impact development decisions.
  • Key contributor (author/and or reviewer, as required) to high-quality clinical pharmacology plans and content for global regulatory documents including protocols, investigator's brochures, briefing documents, IND applications/annual reports, responses to regulatory queries, CSRs, and Clinical Pharmacology and Biopharmaceutics Summary Documents in NDAs/MAAs.
  • Ensure adherence to agreed timelines and budgets to insure prompt and accurate execution of deliverables from clinical pharmacology studies and programs.
  • Oversee clinical pharmacology and pharmacometrics consultants.
  • Maintain and establish relationships and agreements with contract vendors.
  • 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 (Investigator Meetings, Data Monitoring Committee (DMC) meetings or others), as required.
Requirements
  • PhD or PharmD degree with emphasis in clinical pharmacology and experience with clinical pharmacology studies is expected.
  • 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, modelling 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; ability to use systems and tools (e.g., EDC systems, Excel, etc.) for data collection, analysis, and reporting.
  • Strong quantitative skills, including solid familiarity with statistical concepts.
  • Ability to critically analyze problems and provide creative solutions.
  • Scientific rigor in experimental design, study conduct, analysis, interpretation, and communication of results.
  • Ability to effectively communicate pharmacokinetic concepts to diverse audiences, including rationale for study designs.
  • Contribute to the production and authoring of scientific documents with full attention to accuracy and consistency.
  • Demonstrated ability to work effectively in a matrixed, team environment, manage multiple priorities, and exercise sound judgment.
  • Experience in the management of outsourced development programs.
  • Experience in working and influencing cross-functionally.
  • Exhibits high motivation and high energy level, self-starter.