Career History

UNICHEM LABORATORIES LTD ( From 14 July 2018 – 14th April 2024 )

Unichem Laboratories Ltd, is a Indian Multinational company having Offices in Mumbai, USA, UK, SA, Ireland, Brazil

Joined as Associate VP (Global Head) – Clinical Development, Medical Affairs and Global Pharmacovigilance 

Responsibilities:

Clinical Development and Global Medical Affairs –

  • Heading Early Clinical Development programs for Original Research Molecules ( Oncology, RA, Immunotherapy)
  • Leading One NBE and one NCE Molecule
  • Concept development for lead indications
  • Working along with the generics team for evaluation and product development
  • Conducting Bio availability and Bio equivalence studies
  • Conduct of the complete Non Clinical Studies for Rodents Non Rodents registration with FDA
  • Conducted more than 500 pre clinical studies
  • Conduct of the Safety Pharmacology studies, Mechanistic, Toxico kinetics studies
  • Evaluating CROs for Pre-clinical and Clinical studies
  • Audit of the CROs, Contract Negotiations
  • Development of the Clinical Development Plans
  • Review of the and finalization of the clinical protocols
  • Conduct of the Clinical Trails, Real World evidence studies, Surveys
  • Heading Global Medical Affairs – Responsible for Product Launches, Training, Scientific Literature, Medico Marketing
  • Advisory Board Meeting, KOL engagement programs, CMEs, Round Table meetings
  • Academic Institute collaboration, Scientific Advisory meetings, Guidelines Preparation

Strategic Marketing & Product Lifecycle Management –

  • Global & Regional Marketing Strategies – Develop customized marketing plans for India and international markets, ensuring compliance with regional regulations and market dynamics
  • Brand Positioning & Market Expansion – Implement data-driven strategies to position products effectively, capture new market segments, and maximize revenue growth
  • Lifecycle Management & Portfolio Optimization – Extend product life cycles through indication expansion, formulation innovation, and combination therapies, ensuring sustained market relevance.
  • Omnichannel & Digital Marketing Integration – Leverage AI-driven analytics, digital platforms, and targeted physician engagement for optimized brand promotion and customer retention.
  • KOL & HCP Engagement Programs – Build strong Key Opinion Leader (KOL) networks to drive scientific advocacy, market penetration, and physician adoption.
  • Regulatory & Market Access Strategy – Navigate complex pricing, reimbursement, and regulatory frameworks to ensure product approvals and optimal market access
  • Innovative Medico-Marketing Approaches – Utilize real-world evidence (RWE), patient-centric campaigns, and personalized marketing to differentiate brands in competitive markets.
  • Cross-Functional Leadership – Collaborate with R&D, regulatory, sales, and manufacturing teams to align business objectives and enhance product performance.
  • Emerging Market Expansion & Business Development – Identify high-potential markets in Asia, the Middle East, Africa, and Latin America, tailoring go-to-market strategies for diverse consumer needs.


Global Head for Pharmacovigilance and Global Safety Programs –

  • Heading Pharmacovigilance for Globally marketed products and CTs , for USA, Europe, Brazil, African and Asian countries
  • Responsible Qualified Person for Pharmacovigilance for many countries
  • Point of contact for Pharmacovigilance in the organization for all QPPV
  • Ensures compliance with applicable Regulations and Standard Operating Procedures; specializes in drug safety management and medical supervision
  • Responsible for conducting, monitoring or reporting regular pharmacovigilance developments and supervising the processes related to ensuring drug effectiveness and monitoring adverse effects of marketed products.
  • Established Global Pharmacovigilance Department, System, SOPS in various geographical locations
  • Review of ICSRs, PADERS, PBRERS, PSUR, PSMF, Signal reports and submission of the same with 100 % compliance
  • Submission of the SAE on time to regulators and cross reporting across the globe
  • Review of the Call for Medical Information , Medical queries, PV Training, QPPV for EU and UK
  • Conduct internal audits, facing regulatory audits from US FDA, EU and African countries

BIOCON is one of the largest Multinational Indian pharmaceutical company having offices all over the world including in USA and Europe. It’s the Top 10 Biopharmaceutical company in the world and leader in Biosimilars

Head for Medical Affairs and Clinical Development ( Branded Formulations, Biosimilars ) – 

  • Heading the Medical Affairs Department (Diabetology, Oncology, Critical Care, Nephrology, Immunology & Speciality Div)
  • Handling total team size of 35 including Directors, Medical Advisors and MSLs
  • Heading Clinical development and Operations- Responsible for conducting Phase I to Phase IV Clinical Trials
  • Strategic Team member for ideation and implementation for India and developing markets
  • Responsible for Medical affairs including medico marketing
  • Responsible for new product launches and development of the strategy
  • Supporting Pharmacovigilance activities with PV team

Highlighted Achievements – 

  • Guinness Book of world Record for conducting Self screening of Breast Examination; 2016
  • Awarded Best Poster award in World Cancer & Onco diagnostics Conference(WCC); 27-28 Nov; 2017
  • Doing various Phase III clinical Trials in Head and Neck, Cervical and Glioma Cancer in Indian population with Nimotuzumab
  • Doing various Clinical Trials in Diabetology with early use of Insulins, Gastroparesis, QOL, Compliance etc
  • Doing many outcome studies for various Oncology indications and products like Nimotuzumab, Trastuzumb and Bevacizumab
  • Presented Scientific papers in ASCO, ESMO, ESMO ASIA , MASCC 2017, WCC international conferences
  • Published various scientific papers in Oncology, Diabetes, dermatology etc in Scientific Journals
  • Conducting various screening camps for Breast Cancer, Cervical Pap smear screening etc in rural Indian population
  • Published around 50 scientific paper including abstract in Scientific Journals

EMCURE is one of the largest Indian pharmaceutical company having offices all over the world including in USA and Europe. It is strong in Baranded Generics and Biosimilars

Head – Medical Affairs and Clinical Development for Super Specialty Division –  

  • Heading the Medical Affairs Department (Oncology/ Nephrology/ Gastroenterology )
  • Heading Clinical development and Operations- Responsible for conducting Phase I to Phase IV CT
  • Strategic Team member for ideation and implementation for India and developing markets
  • Responsible for product identification, Clinical Development and Clinical Operations
  • Responsible for Medical affairs including medico marketing
  • Responsible for new product launches and development of the strategy
  • Medical Training to Product management team and Field force
  • Medical Support to the international Marketing team

Highlighted Achievements – 

  • Initiated Peg Asperginase Clinical Trial in Relapsed ALL patients for the first time in country
  • Multicentric Clinical Trial of Tenecteplase in Acute ischemic stroke
  • PK study of Treosulphan HSCT patients
  • Conducted Observational Studies
  • Conducted several Advisory Board meetings and  Expert Forum meetings in Oncology and Gastroenterology

 

Dr.Reddy’s does what matters most to patients: accelerating access to affordable medicines and finding solutions for unmet needs.

Director for Clinical Development for India; Promoted Head Clinical development for Asia Pacific Region.

  • Incharge of Clinical Development and Clinical Operations for Global Clinical Trials for India and Asia Pacific Region.
  • Clinical Lead for Multicentric Clinical Trial in USA for Promius Pharma and Proprietary Div of Dr. Reddys esp for Dermatology, Neurology and Infection( Initiated various CT in USA and India)
  • Strategic Team member for Clinical Development/ Medical affairs programs mainly for Promius Pharma (Derm Div of DRL)
  • Responsible for CRO Evaluation and finalization for conducting the Global Clinical Trials in India & internationally.
  • Conducting Bioequivalence studies for differentiated formulations and for global partners.
  • Medical Monitor for the Global Clinical Trials.
  • Developing KOL Board and regularly organizing national and international meetings

Highlighted Achievements – 

  • Clinical Lead and supervising Clinical Operations for the Clinical trial of DFA02 conducted in 40 sites in USA. Involved in protocol development, CRF and other study related documents, CRO selection, site selection, Investigator meetings
  • Successfully completed Metronidazole DF trial in C. difficile diarrhea in 15 sites in India. Clinical lead and incharge of CT, Protocol and CRF development, CRO evaluation and finalization, Investigator meeting. It was one of the difficult trial wherein we had to collect PK sample at the start and at the end of the study
  • Successfully completed multicentric CT on Non Healing Ulcer in 15 sites in India
  • Finalised the pre operative guidelines for few centres in the India
  • Conducted telephonic surveys and telecom with several KOLs from Russia, Mexico for DRL Projects
  • Worked with KOLs from Australia and Singapore for some of the projects
  • Evaluated several CROs in Singapore and Australia for DRL projects
  • Medical monitor for several PK and bio equivalence studies in India and abroad

Global Medical Director for Akela which is Subsidiary of Akela Pharma, USA – 

  • Established the Indian Operations in Mumbai,for Regulatory and Clinical Operations.
  • Supporting global Pharmacovigilance program for ongoing clinical trials
  • Certified Trainer of Akela Pharma to provide Fentanyl Taifun Inhaler Training for Marketing Team and all the Akela Clinical Trial monitors, CRAs and Global Investigators involved in the Tr
  • As Global Medical Director providing Medical Monitoring and Medico marketing Support to the Global te
  • In charge of Global Clinical Operations and successfully conducted trials in Poland, Italy, UK, Thailand etc
  • Trained Indian and Thailand Investigators in Thailand and European Investigators in Zurich; Switzerland.
  • In charge of Regulatory Affairs and Clinical Operations in Ind Working on Narcotic Global Clinical Trial in India. Got approval for Trials in India from DCGI and the Central Bureau of Narcotics.
  • Organizing and conducting Investigators meeting, Supervising Site initiation, Investigators and Site personnel Training
  • Reporting to the Board of Director and Global CEO.
  • Clinical Operations Head, Global Project Managers, Safety Officer, CRAs, Site Coordinators, Finance, Administration and HR, CRO reporting to me.

Head of Medical and Regulatory Affairs, Pharmacovigilance and Clinical Research, in India –

  • Responsible for setting up of the Indian Operation, registered the Company and the products with the regulatory authorities and instrumental in launch of Eisai’s Global products in India.
  • Responsible for Global Clinical Trials Operations in India
  • Qualified Person for PV (Regional Safety Officer) for India and neighboring countries
  • Completed various registrations trials in India

Highlighted  Achievements –

  • India became the second country to get the approval for Vascular dementia in the world
  • Pharmacovigilance Head in India
  • Formation of the Advisory Board for Dementia for developing the Memory Clinics guidelines for the FIRST TIME in India (Published)
  • Setting up of more than thirty memory clinics in India for the first time

Unichem Lab was founded in 1944 by the late Mr.Amrut Mody,with a rich tradition of unwavering quality and reliability, Unichem  brings together a unique blend of modern, value-added research and deep knowledge of the Indian Pharmaceuticals industry.

Head of Medical Affairs, Regulatory & Clinical Research and Medico Marketing

Joined as General Manager–Medical Services – 

  • Responsible for getting the various approval for marketing from The Drugs Controller of India,Conducting various registration
  • Clinical Trials, Launching products for marketing in India.

Highlighted Achievements –

  • Registration of new molecules (around 125) for marketing and manufacturing with the Drug Controller General of India.
  • Conducted Phase III and Marketing Clinical Trials in India            
  • Conducted Press Conference on LORD (Losartan and Ramipril FDC treatment in Diabetes Patients)Trial
  • Conducted various CMEs for the various new product launches in various cities in India
  • Invited International Speakers for conducting the Global CME
  • Conducted various Post Marketing Surveillance Studies and Bioequivalence Studies in India

General Manager–Medical Services (Joined as Medical Advisor) –

  • Responsible for launching various molecules in India
  • Conducted Multicentre Clinical Trials across various centres in India, PostMarketing Surveillance studies
  • Head of medical training
  • Coordinating With The Drug Controller General Of India For New Drugs Registration, ClinicalTrials, BioequivalenceStudies
  • Prepared A Medical Film On “Use Of Ethamsylate In Various Clinical Conditions“ and conducted CMEs in different cities

Piramal Healthcare Limited was later merged with the group flagship Pharma company Nicholas Piramal India Ltd.

Assistant Manager:

Joined as Sr. Executive – 

  • Coordinating Clinical Trials and assisted in several Clinical Trials (L.T.M.MEDICALCOLLEGE).
  • Medical Representative Training-Conducted Complete Medical Training For Boehringer Mannheim & Piramal Health Care Field Force After Merger with NPIL.
  • Launched Cytogard (Trimetazidine), Orthobid (Nimesulide) & Anti–TBProducts.
  • Answering Queries to the Doctors, support regulatory department for Approval of New Molecules.
  • Working On Medline Database and Internet and Writing Medical Product Manuals.
  • Conducting Post-Marketing Surveillance on Ciprofloxacin and Tinidazole Combination.
  • Clinical Trial on Alcoholic Hepatitis, Syndrexin Diabetes Mellitus Patients.