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
PhD or Pharm D -At least 10 years of general drug development experience in the pharmaceutical industry
At least 5 years' experience in clinical pharmacology work in the pharmaceutical industry
Demonstrated success in managing global clinical pharmacology activities
Experience in biopharmaceutic aspects of formulation development
Experience in interactions with regulatory agencies globally
Considerable organizational awareness (inter-relationship of departments, business priorities, etc.)