• Serves as the Clinical Pharmacology representative and provides clinical pharmacology expertise on designated programs and clinical studies
• Provides Clinical Pharmacology expertise for, but not limited to, the development of novel formulations (e.g. modified release)
• Plans and directs clinical pharmacology components of clinical programs (including clinical development plan/life cycle plan) and studies (including synopsis preparation; clinical phase oversight, reporting)
• Leads multifunctional study team to design, deliver and report the assigned clinical pharmacology studies and has overall scientific accountability for the designated studies.
• Responsible for appropriate summarizing and interpreting results of pharmacokinetic/pharmacodynamics analyses with respect to their impact on development and clinical use of drugs.
• Provides Clinical Pharmacology support for labelling requirements
Responsibilities-
• Clinical Pharmacology representative on GEP programs / studies.
• Responsible for providing the clinical pharmacology components of Clinical Plans and provides clinical pharmacology expertise to the project team.
• Has an intimate understanding of the overall clinical development plan and works closely with the Clinical and Development Team to continually update and refine plan.
• Assures that assigned CP study(ies) fulfils its role in the overall development plan
• Plans, designs and oversees clinical pharmacology studies as required with operational assistance from Clinical Research Operations
• Accountable and responsible for assigned synopsis and study report content
• With study team, tracks emerging clinical pharmacology profile of the drug, keeps line management informed of changes in the profile as they occur in the assigned study(ies)
• Must be fully knowledgeable about the clinical pharmacology profile of allocated drugs on which studies are being conducted or which are called for in the protocol.
• Coordinates with medical writers (and other team members) in the data review, analysis and reporting of the CP study
• Be responsible, in conjunction with medical writer, for overall content and accuracy of study report before forwarding for final sign-off
• Assist with internal and external dissemination of results to Development Team, Investigators etc
• Accountable and responsible for non-compartmental analysis of PK data and accountable for ensuring appropriate modelling and simulation in conjunction with Pharmacometrics.
• Leads clinical pharmacology contributions to all regulatory documents including Investigator Brochures, Clinical Overviews, and regulatory filings.
• Leads the resolution of clinical pharmacology queries from regulatory agencies, takes a lead role in writing and reviewing responses to regulatory queries