Chirag Shah

Vice President - Global Medical Research @ Lupin

About

Innovative, futuristic, strategic thinker with strong analytical, entrepreneurial and people management skills. Physician, researcher and inventor with hands-on and leadership experience in clinical development & medical affairs within pharmas of all types- large, mid-size and biotechs. Expertise in leading global clinical development of new chemical entities (NCEs), biosimilars & value added generics (505b2s) for advanced markets (US, Europe, Japan etc) as well as emerging growth markets. Led multiple programs from translational to IND to conducting Phase 1, 2, 3 studies and successful NDA/MAA/BLA. Proven track record of conceptualizing, developing and scientifically positioning new drugs and biologics in Oncology, Immunology, CNS, GI, CVS, Hematology & Infectious Disease areas, many of which have become leading brands in the markets they operate.

Country

India

City

Pune Division

Industry

Pharmaceuticals

Skill

Team Management, Product Selection, Due Diligence, Endometriosis, R&D Management, Phase II, Development Strategy, Consulting, Research Skills, Data Analysis, Strategy, Management, Clinical Development, Pharmaceutical Industry, Clinical Research, Medical Affairs, Clinical Trials, Drug Development, Product Development, Medical Writing

Experience

Vice President - Global Medical Research

Lupin

2023-4 - Present · 3 yrs 6 mos

Leading Global Medical Research group at Lupin. Spearheading clinical development and medical research for biosimilars, new chemical entities and novel product pipeline. Managing new product ideation, evaluation and clinical development for 505b2 pipeline.

Senior General Manager - Medical Research

Lupin

2019-7 - 2023-3 · 3 yrs 9 mos

Leading teams involved in global clinical development, clinical strategy, operations, medical writing and biostatistics for Biosimilars, NCEs and New Products at Lupin. Launched 4 biosimilars for Lupin. Spearheaded oncology clinical trials for Lupin's NCEs including co-development for big pharmas.

General Manager - Medical Research

Lupin

2015-1 - 2019-6 · 4 yrs 6 mos

Pune

Heading global clinical development team for NCEs and Biosimilars, medical affairs for emerging markets and new product innovation. Shaped clinical development strategies for multiple Biosimilars and NCEs of Lupin across different therapeutic areas. Led sceintific consultations with various regulatory agencies and played a crucial role in partnering activities of Lupin for NCEs and Biosimilars.

Assistant Director -Medical Research

LUPIN LIMITED

2009-11 - 2015-1 · 5 yrs 3 mos

Leading clinical research strategy & planning for global development of NCEs & Biosimilars. Established medical writing, clinical strategy and sciences, biostatistics groups for Biosimilars and NCE research. Led new product ideation, innovation and development for advanced and emerging markets.

Head - Global Clinical Development

Kemin Industries

2008-11 - 2009-11 · 1 yr 1 mo

Head of global clinical development team (operations and regulatory affairs) and medical affairs for early phase (phase I, II) clinical candidates. Responsible for leading the Joint Steering Committee meetings and due-diligence activities with Japanese pharma major (Meiji Seika) and other international collaborators and potential partners.

Manager Medical Services

Emcure Pharmaceuticals Limited

2004-3 - 2008-11 · 4 yrs 9 mos

Successful clinical development and launch of >12 new unichiral drugs for the first time in India. Medico marketing, field force and doctor trainings & CMEs for various therapeutic segments. Leadership role in launching several antiretroviral drugs in India for first time. Instrumental in strategically and scientifically establishing concept of chirality by driving Peer-reviewed publications' initiative (published more than 40 manuscripts in various formats for KOLs), engaging KOLs. Got leading medical pharmacology textbook's endorsement for differentiated therapeutic entities of Emcure.