Job Description
Our client, a young Biotech company with an exciting pipeline, now have approval for a Head of Clinical Pharmacology role within their growing Clinical Science team, who will be based in either Ireland or the UK. This hire will oversee clinical pharmacology and PBPK consultants, ensuring appropriate PK, PD and PK-PD data analyses are conducted for each study/program to enable achievement of the company's objectives.
This hire will be the clinical pharmacology expert for the company and will be responsible for leading studies and projects within the project team, including design, oversight and evaluation of phase 1 studies. In addition, the position will include PBPK modelling activities to support early and late-stage development.
This hire will take clinical pharmacology responsibility for regulatory interactions e.g., pre-IND meetings, IND submissions, EoP2 meetings, pre-NDA meetings, NOA and MAA submissions.
The ideal candidate will be an experienced Clinical Pharmacologist operating at Director level in either Pharma or Biotech environment, with the attitude and ability to be effective in a lean, small company environment.
Responsibilities include:
· 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.
· Integrates 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. Partners with relevant stakeholders from discovery through commercialization.
· 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.
· Ensures adherence to agreed timelines and budgets to insure prompt and accurate execution of deliverables from clinical pharmacology studies and programs.
· Oversees clinical pharmacology and PBPK consultants.
· Maintains and establishes 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 include:
· 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.
