Summary
Overview
Work History
Education
Skills
Affiliations
Languages
Therapies Handled
Regional Experience
Regulatory Description
Pharmacovigilance
Medical Governance
Medical Information Description
Pharmaceutical Training
Oncology Workshop Training
Advanced Medical Advisors Training
Effective Presentation
Medical Directors Induction Training
Medical Writing Workshop
Evidence Based Medicine
Medical Affairs Experience Launches
Audits
Business Development
Clinical Research
Oral Presentations
Social Activities
Spouse Profession
Awards
Publications
Personal Information
Timeline
Receptionist
Rajesh Naik

Rajesh Naik

Mumbai

Summary

Accomplished medical affairs leader with over a decade of experience at renowned MNCs like GSK, Boehringer-Ingelheim India Ltd, and Astellas, specializing in Oncology and other Specialty Therapeutic Areas. With a robust industry tenure of 21 years, excels in orchestrating successful product launches, devising strategic plans, managing stakeholders effectively, and ensuring adherence to ethical standards for fostering cross-functional collaboration. Expertise lies in scientific engagement, KOL management, sales training, and development, showcasing a keen eye for detail and the ability to adapt swiftly to overcome obstacles.

Overview

24
24
years of professional experience

Work History

Vice President India and Emerging Markets

Glenmark Pharmaceuticals Ltd
01.2020 - Current
  • Portfolio, Innovation, Analytics and Competitive intelligence

Head Medical Affairs - Specialty

Boehringer-Ingelheim India Ltd
03.2013 - 01.2020
  • Launches: Afatinib (Xovoltib) and Nintedanib (Cyendiv - Indian Brand name for Ofev)
  • ASCO Publication on EGFR testing patterns in India
  • SEC presentation for marketing authorization of Oncology and Respiratory assets

Head Medical Affairs

Astellas Pharmaceuticals India
09.2010 - 03.2013
  • Launch of Advagraf (Once a day Tacrolimus)
  • Contributed to medical governance committee at GSK, ensuring adherence to regulatory standards.
  • Participated in Ethics and Compliance Committee at OPPI, promoting ethical practices within operations.

Senior Medical Advisor

GSK
07.2006 - 09.2010
  • Launch of GSK Oncology and Tykerb (Lapatinib) first time in India
  • Named safety contact for pharmacovigilance activity

Sr Manager Medical Affairs

Ranbaxy
04.2004 - 07.2006
  • Launched Respiratory Division with Multi dose Inhalers, Storvas AMF, Combination of Atorvastatin + Aspirin (Duocad) for CV, Storvas EZ, Dutagen (Dutasteride) and Alfuzosin for Urology, Riconia for Stancare, Montelukast granules for Pharma, Metformin Liquid for the first time in India for CV division

Business Development Support

GSK
04.2004 - 07.2006
  • Part of the due diligence team prior to acquisition of Stiefel.

Clinical Research

KEM Hospital & Seth GS Medical College
01.2001 - 01.2004
  • Bioequivalence study of Clopidogrel. An In- Vivo pharmacodynamic evaluation of effect on bleeding time and platelet aggregation inhibition as bioavailability parameters as Clopidogrel undergoes rapid metabolization after oral administration. Reference drug was Plavix manufactured by Bristol Mayer Squibb.

Clinical Research

DCP KEM & WHO
04.2002 - 01.2003
  • Filariasis Study of Dept of Clinical Pharmacology. The study was done in collaboration with the Dept of PSM, MGM Medical College, Wardha to compare the safety and efficacy of combination of Albendazole and Diethylcarbamazine citrate with DEC.

Education

MD - undefined

Pharmacology
Mumbai

MBBS - undefined

Mumbai

DO - undefined

Diploma in Ophthalmology
Mumbai

DRIP - undefined

Drug Regulatory and Intellectual Property Studies

Skills

  • Medical strategy
  • New Product launches
  • KOL engagement
  • Cross-functional collaboration
  • Ethical Promotion
  • Critical thinking
  • Stakeholder Management
  • Team building and management
  • Attention to detail
  • Training & Development
  • Business & Interpersonal communication
  • Decision-making
  • Friendly, positive attitude
  • Flexible and adaptable
  • Risk management/making mitigation plans

Affiliations

  • European Society of Medical Oncology, 2016
  • European Respiratory Society
  • Indian Chest Society
  • Indian Society of Clinical Research, Life membership
  • Bombay Ophthalmic Association, Life membership
  • Indian Pharmacological Society, Life membership

Languages

English
Hindi
Marathi
Gujarati
Kannada

Therapies Handled

  • Oncology
  • Immunosuppressants in Transplant
  • Anti-infectives - Anti-virals/ Anti fungals/HIV
  • Urology
  • Respiratory care with Asthma (Inhalers)
  • Dermatology (Stiefel and GSK classic brands)
  • Nephrology

Regional Experience

  • Singapore, Advisory board for transplant physicians. Regional clinical commercial and regulatory (CCR) team.
  • Malaysia, Speaker at CME in Malaysia
  • Thailand, Training of Thailand sales team.
  • Japan, Product Training for APSA brand managers.

Regulatory Description

Technical Presentation and medical support for regulatory approval for Retapamulin, Tykerb, Revolade, Votrient & Afatinib in India

Pharmacovigilance

  • Astellas, Deputy Drug Safety officer (DDSO)
  • GSK, Named Safety Contact (NSC) Back Up

Medical Governance

  • Compliance Officer, Astellas Pharmaceuticals India Ltd
  • Member, medical governance committee of GSK
  • Member, Ethics and Compliance Committee of OPPI

Medical Information Description

Set up the entire medical information services in Astellas

Pharmaceutical Training

Physician Foundation course at Greenford (UK), Medical Governance, Medical Information, Pharmacovigilance, Commercial environment, Corporate Communication, SOPs, Codes and Medico-legal issues.

Oncology Workshop Training

  • Beijing, 2006
  • Kuala Lumpur, 2007
  • Singapore, 2008
  • Switzerland, 2009
  • Turkey, 2009
  • Chicago, 2010
  • Seoul, 2010

Advanced Medical Advisors Training

Bangkok, 2008

Effective Presentation

Bangkok, 2008

Medical Directors Induction Training

UK, 2010

Medical Writing Workshop

BMJ, 2010

Evidence Based Medicine

St John's Hospital Bangalore, Mac Master University, Canada

Medical Affairs Experience Launches

  • Boehringer-Ingelheim India Ltd, Afatinib (Xovoltib)
  • GSK, Oncology-Tykerb (Lapatinib), Zemetril (Cefprozil), Cefspan (Cefixime)
  • Astellas, Advagraf (prolonged release tacrolimus)
  • Ranbaxy, Respiratory Division with Multi dose Inhalers, Storvas AMF, Combination of Atorvastatin + Aspirin (Duocad) for CV, Storvas EZ, Dutagen (Dutasteride), Alfuzosin for Urology, Riconia for Stancare, Montelukast granules for Pharma, Metformin Liquid for the first time in India for CV division

Audits

  • Faced 4 audits without any critical or major findings
  • Worldwide GSK Regulatory compliance Audit, 2008
  • Takeda LOC partner audit, 2010
  • Compliance audit, 2012, Astellas
  • PV audit, 2012, Astellas

Business Development

  • GSK, Core Team member at Seoul Korea, for in-licensing deal with Amgen for the oncology portfolio.
  • GSK, Part of the due diligence team prior to acquisition of Stiefel.

Clinical Research

  • Bioequivalence study of Cyclosporine microemulsion in healthy male volunteers., Arpimune ME microemulsion solution of RPG Life Sciences compared with Neoral microemulsion.
  • WHO – Filariasis Study, The study was done in collaboration with the Dept of PSM, MGM Medical College, Wardha to compare the safety and efficacy of combination of Albendazole and Diethylcarbamazine citrate with DEC.
  • CIPLA – Bioequivalence study of Clopidogrel., An In-Vivo pharmacodynamic evaluation of effect on bleeding time and platelet aggregation inhibition as bioavailability parameters as Clopidogrel undergoes rapid metabolization after oral administration. Reference drug was Flavix manufactured by Bristol Mayer Squibb.
  • DST IH – Antiplatelet activity of Cardipro, A poly herbal preparation in hyperlidemics. In-vitro study to see the effect of the polyherbal preparation in hyperlidemics individuals.
  • Phase 3b study of Afatinib in EGFR mutation positive NSCLC
  • PMS Study for Nintedanib in NSCLC and IPF

Oral Presentations

  • Antiplatelet effect of Cardipro a polyherbal preparation, Indian Pharmacological Society, 2002
  • Role of Medical Advisor in Pharmaceutical Industry, Pharmatech 2008, Seth G S Medical College and KEM hospital, Mumbai
  • Evolution of Topical Corticosteroids, CUTICON KT 2008, IADVL Karnataka & Tamil Nadu
  • Evaluation and Review of Promotional material, Pharmatech 2013, 2015, Seth G S Medical College and KEM hospital, Mumbai
  • Ethical Pharmaceutical Advertising, American College of Clinical Pharmacology (ACCP) / Maharashtra University of Health Sciences (MUHS)

Social Activities

  • Operated on poor cataract patients in rural Maharashtra.
  • Worked as a medical officer in state health services and handled a population of 45000 ensuring effective implementation of national programmes like TB and malaria.

Spouse Profession

Dermatologist

Awards

  • Astellas, Star Award, Global recognition award for best individual performance at Astellas India
  • GSK, Prize for the best scientific knowledge, At Regional Medical Advisor network in Singapore.
  • BI, Award for emulating BI value of Respect

Publications

  • Patterns of EGFR testing for lung cancer among tertiary care centers in India, ASCO Annual Meeting, 2015, e19114, J Clin Oncol 33, 2015 (suppl; abstr e19114)
  • Practical Recommendations for managing TKI induced Side Effects, Indian Journal of Cancer, 2016

Personal Information

  • Number of Children: 2
  • Date of Birth: 09/15/73
  • Marital Status: Married

Timeline

Vice President India and Emerging Markets

Glenmark Pharmaceuticals Ltd
01.2020 - Current

Head Medical Affairs - Specialty

Boehringer-Ingelheim India Ltd
03.2013 - 01.2020

Head Medical Affairs

Astellas Pharmaceuticals India
09.2010 - 03.2013

Senior Medical Advisor

GSK
07.2006 - 09.2010

Sr Manager Medical Affairs

Ranbaxy
04.2004 - 07.2006

Business Development Support

GSK
04.2004 - 07.2006

Clinical Research

DCP KEM & WHO
04.2002 - 01.2003

Clinical Research

KEM Hospital & Seth GS Medical College
01.2001 - 01.2004

MD - undefined

Pharmacology

MBBS - undefined

DO - undefined

Diploma in Ophthalmology

DRIP - undefined

Drug Regulatory and Intellectual Property Studies
Rajesh Naik