Responsible for providing the clinical pharmacology components of the clinical development plan and provides clinical pharmacology expertise to the project team under the supervision of senior clinical pharmacology leads.Has a thorough understanding of the overall clinical development plan and works closely with the clinical sub-team and development team to continually update and refine the plan.With Clinical Lead, assures that assigned clinical pharmacology studies fulfill their role in the overall development plan.Plans, designs and oversees clinical pharmacology studies as required with operational assistance from DC Development Operations. Accountable and responsible for assigned synopsis and study report content under the supervision of senior clinical pharmacology leads.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 studies. Must be fully knowledgeable about the clinical pharmacology profile of allocated drugs for which studies are being conducted or which are called for in the protocol (e.g. interacting drug).Coordinates with medical writers (and other team members) in the data review, analysis and reporting of clinical pharmacology studies. Is responsible, in conjunction with medical writer, for overall content and accuracy of study report before forwarding for final sign-off. Assists with internal and external dissemination of results to Development Team, Investigators etc.Is a coach and mentor for the clinical study team for the specifics of clinical pharmacology protocols and therapeutic area in which it is being conducted.Accountable for non-compartmental analysis of PK data and for ensuring appropriate PK-PD analysis including population PK, PK-PD modeling and simulation, meta-analysis etc. Using tools such as NONMEM and R. Directs the planning of all relevant PK-PD analyses.Responsible for use of quantitative methods to integrate knowledge of PK, PD, patient characteristics and disease states to optimize doses, dosage regimens and study designs throughout clinical drug development in collaboration with Pharmacometrics and Statistics.Provides recommendations for clinical doses and dosing algorithms (including drug interaction advice, advice for concomitant administration with food, special population dosing, development of novel formulations, biosimilars and generics etc.) to the clinical sub-team and development team and in regulatory documentation such as labeling.Leads clinical pharmacology contributions to all regulatory documents including Investigator's Brochures, CTA and NDA dossier. Leads the resolution of clinical pharmacology queries from drug regulatory agencies and takes a lead role in writing and reviewing responses to regulatory queries.Stays abreast of literature, government guidelines, and internal guidance on clinical trial conduct, including internal SOPs, and regulations for specific projects to which assigned in order to be a team resource of clinical pharmacology knowledge in terms of both medical background and clinical trial design.Ensures that appropriate subject matter expertise is provided to address regulatory agency queries and interactions.Contributes to regulatory strategy and is prepared to provide regulatory defense of the proposed label with close supervision.Able to present quality scientific work at external meetings and publish the scientific work. With line management endorsement, manage and initiate external collaborations with world leading clinical pharmacology experts to develop new methodologies.

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