Ajinkya Inamdar
Serm Head, Vaccines, Executive Director @GSK
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WORK HISTORY
Serm Head, Vaccines, Executive Director @GSK
US
Set strategy and vision for Clinical Safety & PV across COVID-19 mRNA, influenza mRNA, combination mRNA vaccines, and legacy portfolio (Rotarix, Priorix, Priorix-Tetra, Varilrix, Cervarix, Havrix, Engerix-B, Twinrix) plus pipeline assets.2. Lead, hire, mentor, and develop a global team of safety professionals and embedded complementary workers.3. Translate strategy into executable operating plans with clear milestones; deliver medium- and long-term goals.4. Shape and improve policies, processes, and governance to elevate scientific rigor and operational excellence.5. Oversee end-to-end benefit–risk management for assigned products.6. Ensure scientifically sound review/interpretation of clinical, post-marketing, and RWD; escalate safety issues to senior leadership and governance bodies.7. Recommend actions to further characterize, mitigate, and communicate safety risks.8. Drive efficiency and effectiveness to meet the needs of patients and HCPs; support global PV and benefit–risk management for GSK assets.9. Provide medical/scientific judgment, strong analytics, and proactive safety strategy for products in development, prioritizing subject safety.10. Represent GSK Global Safety externally with regulators, key stakeholders, and industry forums.11. Lead a global group including senior staff and team/group leaders; build high-performance culture.12. Make high-quality decisions and solve complex problems in critical situations, balancing supportive and conflicting evidence within the broader context.
EDUCATION
Harvard Medical School
Other; HMX Fundamentals/Pro online certificate program-Gene Therapy
The University of Alabama
Master of Business Administration (M.B.A.), Biotechnology
Harvard Medical School
Other; HMX Fundamentals/Pro online certificate program, MMUNOLOGY - VACCINES AND VIRAL IMMUNOLOGY
Harvard Medical School
Other; HMX Fundamentals/Pro online certificate program, Immunology- Novel Therapies For Chronic Inflammation
Shivaji University
MBBS, Medicine and Surgery
The University of Alabama
Master's Degree, Cell/Cellular and Molecular Biology
Massachusetts Institute of Technology
No Code AI and Machine Learning, Artificial Intelligence
Harvard Medical School
Other; HMX Fundamentals/Pro online certificate program – , Drug Delivery , Vaccine Delivery, CGT Delivery
SKILLS
ABOUT AJINKYA INAMDAR
16+ years in the Pharma industry- Leadership in Vaccine, Immunology, Cell and Gene Therapy Development, Clinical Trials, Product Development, Portfolio Development, Entire PV Function Management, Clinical Safety, Signal Management, Risk Management, PSUR/DSUR/PBRER/RMP/DRMP/iEGP/RWE/TPP/TVP, Risk Minimization Measures, PV Planning and Budgeting, Artificial Intelligence and Automation, Technology and Innovation in Business Processes, Product Safety Boards, meetings with Health Authorities, Medical Review, Reporting to US FDA/EMA/NMPA/TGA/HC, Responses to PRAC/ CBER, Health Canada/ FDA, Multi-project Leadership, Snapgene/Oracle Empirica/RAVE/Oracle Clinical/Oracle Inform, Drug Development, Pilot Study Protocols, Early Molecule Selection, DNA Constructs, Gene Therapy, Cell Therapy, Nano-antibodies, Pre and post-approval safety management, Vendor selection and contract review, Phase to Marketing, New BLA, NDA submissions, Establishing PV for small biotech going into first product license05+ years of Direct Patient Management
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