Pharmaceutical Sciences group enables discovery and development of safe and effective therapeutics at optimal doses in relevant populations with a vision to power translation, continuously improve the accuracy of our predictions and accelerate the development of tomorrow's medicines. Pharmaceutical Sciences supports discovery and development across the whole value chain, from target assessment to on-market.
In close collaboration with the project?s Clinical Pharmacologist, the Clinical Pharmacologist Scientist is responsible for overall planning, management, data evaluation and reporting of clinical pharmacology studies. The Clinical Pharmacologist Scientist leads protocol development and participates in study management as the primary clinical pharmacology representative. He/she provides clinical scientific input for final study reports and annual report documentation, and assists the Clinical Pharmacologist in high-level IND and NDA documentation processes.
Tasks & Responsibilities
- Responsible for the scientific aspects of clinical pharmacology study protocol development, including protocol synopsis, consent form, eCRF and protocol amendments
- Leads the evaluation of clinical pharmacology data, interacting as required with operational staff and investigators, Data Management, Biostatistics, and other partners
- Leads the ongoing review of study data (e.g., PK, PD and safety) and reviews data outputs for scientific and medical validity and consistency
- Assists in the preparation of the clinical pharmacology component of the project specific Investigators Brochure
- Attends and provides science support for investigator meetings and monitor workshops
- Leads the safety review of clinical pharmacology studies and contribute to serious adverse event (SAE) reconciliation and SAE narratives
- Primary scientific responsible for writing final study reports
- MSc, Pharm D or PhD in pharmaceutical sciences, clinical pharmacology sciences (Post Doc considered).
- +2 years of experience in industry setting (preferably Pharma) supporting clinical pharmacology studies, NCA data analysis, regulatory filings and medical writing.
- Clinical research experience, preferably in the pharmaceutical industry, with knowledge of ICH GCP and the drug development process
- Previous experience / working knowledge of various approaches to PK and PD data analysis: compartmental, curve-fitting, non-compartmental.
- Experience on software: Phoenix? WinNonlin? (plus Microsoft & Google Suites)
Nice to Have:
- Knowledge of Spotfire? is a plus.
- Work in a matrix structure for project
For more information, please contact Fandi Hatib on +44 1727 817600 or email email@example.com
- Agency: Achieva Group Limited
- Reference: FH-36
Website: Achieva Group Limited
- Posted: 9th May 2022
- Expires: 6th June 2022