GEP Clinical Pharmacology Lead

DESCRIPTION:
-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 (eg 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/pharmacodynamic analyses with respect to their impact on development and clinical use of drugs.
-Provides Clinical Pharmacology support for labeling 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) fulfills 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

SKILLS:

QUALIFICATIONS:
-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.)
-Team player, results oriented, and problem solver

WHAT ARE THE MOST CRITICAL SKILLS NEEDED?
1. Good understanding of the principles of pharmacokinetics, drug metabolism, biopharmaceutics and clinical pharmacology.
2. Hands-on experience with conducting clinical pharmacology studies.
3. Hands-on experience with preparation of clinical pharmacology sections of NDAs, ANDAs and ex-US equivalents.
4. Strong verbal and written communication skills.