JD for PK/PD lead

- Evaluation and provide clinical strategy (for PK/PD studies) for recent molecules selection for biosimilar development
- Literature review and design PK/PD studies
- Evaluate PK/PD data, covariates and other factors impacting PK/PD and assess PK/PD variability for sample size calculation
- Provide pharmacokinetics and pharmacodynamics analysis of the assigned projects.
- Support in global clinical development of various projects.
- Review and Provide PK and PD inputs for the various assigned projects.
- Preparation/review of PK/PD study synopsis
- Review and provide PK/PD inputs in study protocols, clinical study report, SAP, IB, CRF, clinical modules and other documents of the studies conducted.
- Review study data including protocol deviation before blinded data review meeting to decide the PK population
- Review line-listings and TLFs.
- Prepare and review scientific advise and regulatory documents.
- Provide responses to regulatory agency queries.

📌 Manager (Bengaluru)
🏢 BIOCON BIOLOGICS
📍 Bengaluru