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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: Remote (with occasional travel to client sites)

Job Type: Full-time

About the Role:

We are seeking an experienced Director of Clinical Pharmacology to join our team at The RFT Group. As a key member of our BioPharmaceutical Division, you will be responsible for leading clinical pharmacology efforts for our clients in the biotechnology, pharmaceutical, and medical device sectors.

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 PBPK 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.