Experience

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  Cadila Pharmaceuticals Limited

  • Ahmedabad Area, India

  • Vice President

    • Jul 2019 - Aug 2020
    • Ahmedabad Area, India

    Over all responsible for business delivery of Clinical research (Phase 1 to 4), BA-BE (clinical and bioanalytical) and Preclinical departments and ensure profitabilityTo set business targets and monitor progress of each of the departments for growth (domestic and international business) To coordinate with regulatory bodies and committees To guide the individual department heads for quality, timelines and optimum utilization of resourcesTo oversee all operational/ scientific aspects in Clinical research and Toxicology areas

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  Sun Pharma, Mumbai

  • General Manager-Head India Clinical Research

    • Aug 2016 - Jun 2019

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  Quintiles

  • United States
  • Hospitals and Health Care
  • 700 & Above Employee

  • Head of Regulatory Affairs and Sites Services India

    • Oct 2014 - Jan 2016

  • Associate Director, Clinical Operations and Business Strategy, Sri Lanka

    • Feb 2014 - Jan 2016

    Responsibilities include Identifying potential studies for Sri Lanka; Assess therapeutic area expertise of Sponsors to map key accounts relevant to Sri Lanka; Create awareness of Sri Lanka among key internal and external stakeholders and Provide guidance and oversight to local operations team.

  • Business Strategy Lead

    • Jan 2011 - Jan 2014

    Responsibilities included Engaging customers proactively to secure proposals for new work and translating them into awards; Review and Recommend Operational Strategies for new opportunities, Collaborate with cross-functional teams to support the proposal and budget development there by helping the business to achieve its targets for new business and optimal profitability; Participate in Bid defense meetings and train & prepare the Clinical Project Managers for Bid defenses.

  • Associate Director, Clinical Operations

    • Aug 2008 - Dec 2010

    Main responsibilities included Coaching and mentoring Clinical Team Leaders to manage project related challenges and deliverables in countries managed; Resourcing, appraising performance and guiding professional development of Clinical Team Leaders; Manage the quality of assigned staff's clinical work through regular review and evaluation of work product; Identify quality risks and issues and create appropriate corrective action plans; Ensure that staff were meeting defined workload, quality and budget metrics through regular review and reporting .

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  PPD

  • Mumbai

  • Head, "Clinical Team Managers" -Management

    • May 2007 - Jun 2008
    • Mumbai

    Responsibilities included Resourcing, Coaching and mentoring Clinical Team Managers; ensuring quality in clinical deliverables; Collaborate with other departments and global teams to ensure smooth conduct of studies; Regular Review of contractual deliverables of projects, Line management and support to Clinical Team Managers.

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  SIRO Clinpharm Pvt. Ltd.

  • Mumbai

  • Sr. Clinical Project Manager

    • Jun 2004 - May 2007
    • Mumbai

    Responsibilities included Setting up of Projects, Execution of study deliverables; and track progress and Milestones; Ensure Timelines and budgets were met; Training of study teams; Vendor management; Risk management and Sponsor communications.

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  WellQuest Medical & Wellness

  • Mumbai

  • Head, Clinical Operations

    • May 2003 - Jun 2004
    • Mumbai

    Overall in-charge of activities of clinical section for bioequivalence studies: designingprotocols, ensuring implementation of GCP through standard operating procedures, budgeting, responsible for conducting all contracted studies as Principal Investigator, review of reports, hosting audits and inspections.

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  Walter Bushnell

  • New Delhi

  • Medical Advisor

    • Jul 1999 - Mar 2003
    • New Delhi

    Clinical Trials: Organizing and conducting clinical trials (data Generation) including preparation of protocol, designing case report forms, preparation of investigators’ brochure and presentation at investigators’ meets, project management, preparation and publication of the reports in scientific journals• Medico-marketing: Organizing, conducting and speaking in doctor group meetings / symposia for new product launches or existing products • Responsible for medico-marketing activities: preparing and /or editing promotional inputs (Communication aids, literature, articles, for medical fraternity and patient information leaflets)• Organizing and conducting in-house training programs for the sales and marketing teams

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  Ranbaxy Laboratories Ltd.

  • Quality Assurance Auditor

    • Jul 1998 - Jun 1999

    Responsible for auditing clinical and bioanalytical operations of bioequivalence studies, training and reviewing & formulating standard operating procedures.

  • Medical Pharmacologist

    • Feb 1996 - Jun 1998

    .Review of potential new molecules for clinical development Developing investigators’ brochure and training investigator sites' personnel on the molecule in investigator meets• Responsible for creation of reference data bases and medical information support on products for regional directors/country medical advisors (International).• Preparation of basic concept paper on medical information, summary basis for product approval, patient information leaflets and standard prescribing information for each product for dossiers for international and domestic regulatory submissions• Replying to the medical queries received from international markets

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  Lady Hardinge Medical College

  • New Delhi

  • Senior Resident, Department of Pharmacology

    • Jun 1993 - Jun 1996
    • New Delhi

    Performed basic research and clinical trials• Trained undergraduate and postgraduate students for M.D. Pharmacology and M. Pharm