Research Scientist - Pharmacokinetics

Job description 1) Literature search and design of CT (patient based PK/PD end point studies) 2) Preparation of CT study synopsis, including sample size calculation 3) IMP calculation for Clinical trials 4) Clinical trial monitoring (In process, risk based) 5) Investigational products management 6) Oversee Clinical trial s execution with the help for CRO at hospital sites 7) Center point contact for CRO and internal stakeholders 8) Well understanding of CT related guidance focusing on FDA guidance 9) Understanding the CT (PK end point, PD endpoint) studies data evaluation and report review 10) Controlled correspondence, scientific justification authoring and review