Manager

JD for PK/PD lead:

1. Evaluation and provide clinical strategy (for PK/PD studies) for new molecules selection for biosimilar development

2. Literature review and design PK/PD studies

3. Evaluate PK/PD data, covariates and other factors impacting PK/PD and assess PK/PD variability for sample size calculation

4. Provide pharmacokinetics and pharmacodynamics analysis of the assigned projects.

5. Support in global clinical development of various projects.

6. Review and Provide PK and PD inputs for the various assigned projects.

7. Preparation/review of PK/PD study synopsis

8. Review and provide PK/PD inputs in study protocols, clinical study report, SAP, IB, CRF, clinical modules and other documents of the studies conducted.

9. Review study data including protocol deviation before blinded data review meeting to decide the PK population

10. Review line-listings and TLFs.

11. Prepare and review scientific advise and regulatory documents.

12. Provide responses to regulatory agency queries.

Skills Required
clinical strategy , Pharmacokinetics, literature review, pharmacodynamics