20 years of experience in strategic global medical affairs & clinical development leadership across multiple therapy areas leading cross-functional teams in all major geographies.
Trained as Oncologist/ Internal Medicine/ Pharmaceutical Physician/ Health Policy Management.
Expertise in medical affairs strategy, medical excellence & capability building, launch excellence, successful hands-on national and international experience leading large organizations and teams running drug development clinical research. Expert in bridging development data gaps, generating and disseminating data, innovative medical education programs and translating scientific insights into strategies.
Substantial command improving & creating processes for handling medical compliance; regulations and managing off-label drug use access programs. Track record building capability and efficiency using innovative new tool for HEOR/ Real World Evidence data generation.
Thorough understanding and in-depth knowledge of changing health system dynamic, regulatory and pharmaco-economic challenges including HTA assessments (i.e NICE) and role of pharmaceutical industry as well as non-governmental/private health care providers. Experience in leading corporate responsibility efforts working with health system supporting sustainable health delivery programs
Experience leading drug development and registration with USA (FDA), EU (EMEA), Japan (PMDA), China (CFDA) & other EU/ROW authorities. Champion Ethical Practices with command on IFPMA/EFPIA,ABPI/PhRMA.
Passionate about people development and growth, incorporating on job and role based trainings to build capabilities and develop next generation leadership.