Principal Scientist, Clinical Pharmacology
Up to £785 per day via umbrella
Contract until October 2022
Responsible for leading clinical research activities with focus on clinical pharmacology phase I pharmacokinetics and bioequivalence trials. He/she will ensure that high quality expertise is provided to meet state-of-the-art scientific, industry and regulatory standards.
Provides appropriate clinical pharmacology contributions or author the clinical development plan
- Prepares/reviews/contributes to clinical study protocols
- Reviews/contribute to key study documents e.g. ICF, Statistical Analysis Plan; Analytical Method plan &validations and Bioanalytical documentation
- Reviews/contributes/lead preparation of the Investigator’s Brochure and clinical study reports
- Supervises study setup (in co-operation with Clinical Operations and other study team members review of Task orders and deliverables) and study execution (Kick-off meeting; Site Initiation Visit; regular team meetings; risk management process; issues escalation; management of protocol deviations and blind data review)
- In co-operation with Biostatisticians provides/review clinical trial data for disclosure activities
Key Performance Indicators
- Clinical Pharmacology plan will be high quality documents, provided within the required time frame communicating the required information justifying the clinical strategy and human studies.
- Input in protocols (inclusion and exclusion criteria, AEs of interest etc) will be appropriate for the population and compound –pharmacokinetic and pharmacodynamic expertise will be used to summarize and interpret clinical trial results.
- Clinical Study Protocols’ designs will be state of the art and include external experts where appropriate.
- Developed communication and negotiation skills ensuring their contributions can be made and impact the project.
- Study Protocols, submission responses and other documents will be delivered according to current best practices and compliance regulations, SOPs and within the agreed upon timelines.
- Integrated and well respected member of project- other and (cross)-functional teams.
- Life Science Degree- phD PharmD highly preferred with advanced studies in clinical pharmacology and pharmacokinetics
- Fluent in spoken and written English is prerequisite, knowledge of additional languages
- Minimum of 8 years experience in pharmacokinetics.
- Knowledge of bioanalytical science is preferred
- Experience in pharmaceutical industry or CRO.
- Solid understanding of clinical drug development
- Proven ability to effectively liaise and influence