Rapi Nteene

Md, Gso @Sanofi

Lyon, FR

Leading safe and effective clinical development and post-commercializing activities for Flu, RSV and meningococcal vaccines 2. Guide, Contribute, Review and/ or Approve clinical development plans (CDP), concept protocols, study protocols, SMT planning-halting rules, study signal management, briefing documents for FDA/EMA, investigator brochures, ICFs, data monitoring plans, statistical analysis plan (prepared by biostat), integrated summary of safety, CCDS and label.3. Plan and participate in pre-IND meetings with CBER/ HC/TGA/MHRA. Provide responses to PRAC, EMA, CBER, NMPA (China), TGA (Australia), FDA (India) and other RAs as needed. Support FDA inspection by providing prompt response to questions asked by the inspectors.4. Plan Real World Evidence studies, guide medical reviewers and scientists, line listing review, literature review, Clinical Study Report; register and review signals based on disproportionality. Support the development of product road maps and integrated evidence generation plans. Conduct structured benefit-risk assessment and integrate with CTD 2.5. Provide strategic and proactive safety input into development plans. Conduct investigator presentations, ensure PV audit readiness for (pre/post approval) inspections and provide inputs from external studies on IND annual reports. Ensure establishment of Pregnancy Registries as required by regulatory authorities. Lead presentations to Benefit-Risk Assessment Committee (BRAC), Product Safety Board (PSB), SET, SMT and SMC8. Prepare responses to health authorities. Provide guidance on global SDEAs- collection of safety and efficacy data from studies conducted by license partners while supporting their regulatory requirements. Review contractual agreements for clinical studies.9. Lead cross functional safety management teams (SMTs) and GPE internal safety analysis teams (SAT/SET), IB, Protocol, CTD, PBRER, DSUR, RMP, DRMP, and SRMP