Rajeev Sharan Shrivastava
New Delhi
Summary
Dynamic medical professional and leader with extensive experience in regulatory compliance and clinical trial management at Eli Lilly and Company. Demonstrated success in strategic planning and stakeholder engagement, resulting in significant product portfolio expansions. Skilled in risk management and team leadership, promoting a culture of excellence in clinical operations. Comprehensive knowledge of market trends and corporate finance enhances ability to execute effective business strategies and oversee financial performance.
Overview
22
22
years of professional experience
1
1
Certification
Work History
Director-Regulatory Affairs & Pharmacovigilance
Eli Lilly and Company
03.2018 - Current
- Leading the regulatory affairs and pharmacovigilance responsibility for India & sub region.
- Extensively involved in India affiliate strategy for new product portfolio, planning the pipeline products, clinical research/operations strategy for India and sub region.
- New Product Planning and related coordination for the assigned geography.
- Regulatory alliance management for diabetes portfolio with local companies and work on related governance to ensure regulatory compliance.
- Leading India advocacy for portfolio planning with IBU team for putting across the strategy, related planning and execution.
- Third party alliance management and governance from regulatory perspective and ensure regulatory compliance for India and neighbouring markets.
- Risk management exercise in collaboration with quality function and putting across the mitigation strategy with involvement of related stakeholders.
- Core member of India industry groups for policy shaping and related regulatory interactions within the industry.
- Closely interacting with government agencies with industry groups for planned regulatory changes, product follow ups, approvals and ensuring timely launch success.
- Oversight of Pharmacovigilance responsibilities for India & sub region. Coordinate with affiliate team to ensure compliance to regulations.
- Ensuring audit and inspection readiness for regulatory and pharmacovigilance for India and Sub region.
- Budget Planning and management for Portfolio, Regulatory and Operational activities.
- Performance management for the team, identify talent and support career development.
Head Clinical Operations for India
Eli Lilly and Company
01.2015 - 03.2018
- Leading the India clinical operations team comprising 12 team members including 6 Clinical Development Consultants and 1 Site Activation Manager with a Site Activation team size of another 6 people.
- Third party management for executing clinical studies at country level and oversight by Clinical Development Consultants.
- Working with PDOT and PDST in collaboration with IBU PPM organisation for product and clinical studies (Phase 2 and 3) approval for India.
- Overall finance and budget management for India clinical operation and studies allocated.
- Maintain and succeed in current portfolio of India and work with global teams for India portfolio expansion.
- Work with functional heads of medical, regulatory, corporate affairs to plan strategy based on affiliate long range plan and also coordinate day to day work related to clinical operations.
- Work closely with government agencies (CDSCO, Health Ministry departments) and different industry forums (FICCI, ISCR, OPPI) on important topics related to clinical research and working closely to resolve issues/challenges related to clinical research.
- Work closely with team to reduce cycle time at country level and maintain oversight to resolve operational issue/challenges at project level.
- Oversight of relationship with key investigators at country level and do routine field visits with CDLs.
- Work proactively on challenges related to team and overcome those for clinical operations and mitigate risk.
Regional Project Management Lead (Associate Director-Clinical Research)
Eli Lilly and Company
01.2011 - 01.2015
- Regional responsibility for South Africa, Middle East, Russia, Israel, India, Turkey, Ukraine since 2011 as Associate Director-Clinical Research.
- Leading a team of 8 Clinical Study Project Managers from 5 countries and one CCPM specialist, Conducting performance review and management, Talent management and support career development for regional Project Managers.
- Regular coordination with regional director to work on strategic intent for the region and bring consistency in work approach and cycle time reduction for each country.
- Work closely with operational leaders and PDST on portfolio clinical studies allocation for countries depending on disease state burden, cycle times, market to propose list of countries.
- Regular discussion with CRO/TPOs and other partners working for Lilly in functional outsource model on portfolio execution and addressed challenges faced.
- Follow up with CRO functional head for AMERIT to understand PTL allocation, study management activities, coordination between the PTL and CSM.
- Attend regional and global meetings with respective country clinical operations head of the region and discuss regional matrix focusing on study delivery and cycle times.
- Work with CRO functional head on high level of coordination of project management work so that cycle time could be reduced at country and regional level.
- Provides project management oversight for the region and help regional CSMs in tracking of enrolment, resolves enrolment issues, implements enrolment acceleration and patient retention programs.
- Oversee study specific kick off meetings planned by regional CSMs.
- Regular meeting with individual Clinical Study Project Manager and get study updates and help in resolving operational and project management issues wherever needed.
- Doing Performance management for regional project manager team and help team members to overcome issues and be successful in the role.
Senior Manager-Clinical Research
Eli Lilly and Company
03.2009 - 01.2011
- My work responsibilities included Project management as well as Line management for my team which involved 5 members with global clinical trials in Oncology, Endocrinology, Psychiatry therapeutic areas.
- My job responsibilities include involvement in activities related to country related activities for clinical operations like budget management, Project cost finalisation etc.
- Attending visits at MoH to explain on study protocols along with regulatory affair colleagues.
- Final Patient allocation process management for India. Providing details to senior leadership and following up for India allocation.
- Providing realistic estimation on study bidding process based on experience in disease state/therapeutic area, study timelines, study feasibility.
- Finalisation of study budget and providing it global study team.
- Finalisation of country level timelines, achieving the FPV at country level.
- Ensuring that clinical studies are conducted according to the global timelines and objectives set forth in the overall Project Management Plan.
- Doing the performance management, career development planning for all the team members.
- Interacting with cross functional departments for operational and study specific requirements.
- Looking after different study team project specific requirement and the need of study specific trainings.
- Keeping regular meetings with study team for meeting the quality standards (ICH-GCP, Company SOPs), timelines for the study.
- Helping the team to resolve study related problems/issues. Following up with study teams at regular intervals for timely resolution of issues.
- Taking up responsibility for new initiative at affiliate level for making the operational end more systematic.
- Owning responsibility for the implementation of daily operations associated with managing clinical studies.
- Applying effective project management skills including translating development objectives into relevant, tangible, and measurable goals; monitoring progress toward goals; and participating in problem identification and resolution.
- Better managing the resources in a clinical study.
- Coordinating with the DRA colleagues for MoH submission and approval status.
- Aligning and motivating team members to meet customer needs and organizations’ strategic direction.
- Being responsible for inspiring, motivating and promoting team health.
Manager-Clinical Research
Eli Lilly and Company
07.2007 - 03.2009
- My work responsibilities included Project management as well as Line management for my team which involved 5 members with global clinical trials in Oncology, Endocrinology, Psychiatry therapeutic areas.
- My job responsibilities include involvement in final patient allocation process with corporate based on company’s objective and compound planning.
- Providing realistic estimation on study bidding process based on experience in disease state/therapeutic area, study timelines, study feasibility.
- Finalisation of study budget and providing it global study team.
- Finalisation of country level timelines, achieving the FPV at country level.
- Ensuring that clinical studies are conducted according to the global timelines and objectives set forth in the overall Project Management Plan.
- Doing the performance management, career development planning for all the team members.
- Interacting with cross functional departments for operational and study specific requirements.
- Looking after different study team project specific requirement and the need of study specific trainings.
- Keeping regular meetings with study team for meeting the quality standards (ICH-GCP, Company SOPs), timelines for the study.
- Helping the team to resolve study related problems/issues. Following up with study teams at regular intervals for timely resolution of issues.
- Taking up responsibility for new initiative at affiliate level for making the operational end more systematic.
- Owning responsibility for the implementation of daily operations associated with managing clinical studies.
- Applying effective project management skills including translating development objectives into relevant, tangible, and measurable goals; monitoring progress toward goals; and participating in problem identification and resolution.
- Better managing the resources in a clinical study.
- Coordinating with the DRA colleagues for MoH submission and approval status.
- Aligning and motivating team members to meet customer needs and organizations’ strategic direction.
- Being responsible for inspiring, motivating and promoting team health.
Senior Clinical Research Associate
Novartis Pharmaceuticals
09.2005 - 07.2007
- Company Overview: International Clinical Research Operation running in 72 countries out of global presence of 140 countries
- Worked with Novartis Pharmaceuticals in their clinical research operation which is a part of ICRO.
- I was responsible for phase II to phase IV of clinical trials according to ICH-GCP guidelines.
- I had been involved with two global trials of cardiology (Indications: Hypertension), metabolic diseases (Indication: Diabetes) and one global trial on Dermatology & Immunology (Renal Transplant) across 10 sites.
- I had also been involved with psychiatry trials during the pre-start up and start up activities.
- Here my job responsibilities were mainly related to the following activities: Site Selection: Identifying the potential investigators for the study.
- Contacts and visits potential investigators.
- Ensures adequacy of clinical research staff/facilities with regard to SOPs, GCP, and appropriate regulatory requirements.
- Identifying issues and arranges for resolutions with the help of team members.
- Compiling the regulatory documents and handing over to the regulatory colleagues for MoH submission.
- Doing the EC submission as per the submission timelines of the different sites.
- International Clinical Research Operation running in 72 countries out of global presence of 140 countries
Clinical Research Associate
Reliance Clinical Research Services
07.2004 - 09.2005
- Worked with Reliance Clinical Research Services as a Clinical Research Associate.
- I had been mainly involved with three Oncology projects (Indications: Lung Cancer, Multiple Myeloma, Cerebral Tumours) and one project on Sepsis across seven sites.
- Here my job responsibilities were mainly involving: Prestart up Phase: Collecting all documents for regulatory submission.
- Preparing the internal documents and getting the documents approved as per the company SOPs (mainly ICF, Letter of agreement).
- Organising and doing the EC submission for study approval at the site.
- Interacting with vendors for conducting the start up meeting.
- Site Initiation: Conducting the site initiation visit after receiving the EC approval, approved signed copy of letter of agreement was received.
- Preparing and compiling the site related documents.
- Giving a presentation on the protocol and ICH-GCP guidelines.
- Giving a presentation on informed consent process, SAE reporting.
- Familiarising the site with study related documents which needs to be filled mainly ICF, CRF, Lab requisition.
- Discussion on study related documents and getting it signed from Principal Investigator (Confirmation of source documents, Signature and function log).
- Resolving all the queries related to study related procedures.
Resident Doctor
N.D.M.C Charak Palika Hospital
01.2004 - 06.2004
- Worked with N.D.M.C Charak Palika Hospital, New Delhi as a resident doctor in the Emergency Deptt.
- Reviewing all kind of emergencies.
- Starting the treatment and shifting the patient in respective departments.
- Attending OPD in day duty.
Resident Doctor
Safdarjung Hospital
08.2003 - 01.2004
- Company Overview: Govt. of India
- Worked with Safdarjung Hospital in the Deptt. Of Neurosurgery as a resident doctor.
- Reviewing and managing the inpatient in neurosurgery department.
- Attending and seeing the patient in Neurosurgery OPD.
- Attending the emergency duties and reviewing the emergency cases mainly head injuries (EDH, SDH).
- Govt. of India
Education
MBA - General Management
Indian Institute of Management
Kolkata03-2024
M.B.B.S - General Medicine
University of Mumbai
Mumbai08.2003
XIIth -
G. B Sr. Sec. School
New Delhi01.1996
Xth -
G.B Sr. Sec. School
New Delhi01.1994
Certification in Clinical Research -
Royal College of Physician
UKSkills
- Regulatory compliance
- Clinical trial management
- Risk management
- Budget management
- Product portfolio planning
- Stakeholder engagement
- Team leadership
- Strategic planning
- Third party management
- Policy advocacy
- Visionary leadership
- Cross-functional team leadership
- Project management
- Legal and regulatory compliance
Certification
- Representing Eli Lilly India in India OPPI.
- Part of global regulatory network EFPIA.
- CIPM: Certificate in International Project Management from IAPM, UK.
- VSCR: Certified Clinical Research professional from Vienna School of Clinical Research.
Previous Jobs
- Head Clinical Operations for India, Eli Lilly and Company, 01/01/15, 03/01/18, Leading the India clinical operations team comprising 12 team members., Third party management for executing clinical studies at country level., Overall finance and budget management for India clinical operation and studies allocated.
- Regional Project Management lead (Associate Director-Clinical Research), Eli Lilly and Company, 01/01/11, 01/01/15, Regional responsibility for South Africa, Middle East, Russia, Israel, India, Turkey, Ukraine., Leading a team of 8 Clinical Study Project Managers from 5 countries.
- Senior Manager-Clinical Research, Eli Lilly and Company, 03/01/09, 01/01/11, Project management as well as Line management for my team., Involvement in activities related to country related activities for clinical operations.
- Manager-Clinical Research, Eli Lilly and Company, 07/01/07, 03/01/09, Project management as well as Line management for my team., Involvement in final patient allocation process with corporate.
- Sr. Clinical Research Associate, Novartis Pharmaceuticals, 09/01/05, 07/01/07, Responsible for phase II to phase IV of clinical trials according to ICH-GCP guidelines.
- Clinical Research Associate, Reliance Clinical Research Services, 07/01/04, 09/01/05, Involved with three Oncology projects and one project on Sepsis.
- Resident Doctor, N.D.M.C Charak Palika Hospital, 01/01/04, 06/30/04, Reviewing all kind of emergencies.
- Resident Doctor, Safdarjung Hospital, 08/01/03, 01/31/04, Reviewing and managing the inpatient in neurosurgery department.
Family Details
A.K Shrivastava, Sunaina Shrivastava, Anu Sinha, 2
Personal Information
- Date of Birth: 07/27/78
- Gender: Male
- Nationality: Indian
Projects
India business transition for diabetes, 2021 Third party management from regulatory perspective for India neighbouring countries, 2021 Lilly global project as part clinical development transition to IQVIA, 2021 Six sigma efforts on New Product Planning, 2011 Six sigma efforts on Portfolio Planning, 2011 Setting the Regional CSM team for AMERIT, 2011 Site Activation Team for AMERIT, 2011 Global Site Monitoring Process (GSMP) from India, 2011 Six Sigma Kaizen Project, 2008
Training
- Clinical Trial Summit, 05/01/21, Guest Speaker
- Indian Society of Clinical Research Annual conference, 01/01/16, Guest Speaker
- International Pharmacogenomic conference, San Francisco, 04/01/11, Guest Speaker
- Partnership in Clinical Trial Asia Pacific, 2010, Guest Speaker
- Clinical Trials & Partnering India, 2010, Guest Speaker
- Accelerated Leadership Training Development Program, 05/01/16
- Employee Self Development Program, UK
- CIPM training from IAPM, UK
- Advance GCP training from Vienna School of Clinical Research
- GCP Compliance Exam at Workshop on Clinical Research & ICH- GCP guidelines, Beijing, China
- Effective Communication & Leadership skills, MDI, Gurgaon
- Team Leader training meeting, Shanghai, China
- Oncology Clinical Trial Workshop, Indianapolis, US
- ICH-GCP training from Reliance Clinical Research Services
- Time Management skills from Mercuri International
Current Job
Director-Regulatory Affairs & Pharmacovigilance, Eli Lilly and Company, 03/01/18, Leading the regulatory affairs and pharmacovigilance responsibility for India & sub region., Involved in India affiliate strategy for new product portfolio, planning the pipeline products, clinical research/operations strategy for India and sub region., Regulatory alliance management for diabetes portfolio with local companies., Third party alliance management and governance from regulatory perspective., Core member of India industry groups for policy shaping and related regulatory interactions.
Activities
- Playing Badminton
- Reading Books
- Watching documentaries and movies
Accomplishments
- Received big project accomplishments from global leadership on strategic projects completed in clinical development and regulatory affairs
- Recognized by emerging market leadership for a partnership project with IQVIA
- Achieved regional/local projects with large CFTs.
Timeline
Director-Regulatory Affairs & Pharmacovigilance
Eli Lilly and Company
03.2018 - Current
Head Clinical Operations for India
Eli Lilly and Company
01.2015 - 03.2018
Regional Project Management Lead (Associate Director-Clinical Research)
Eli Lilly and Company
01.2011 - 01.2015
Senior Manager-Clinical Research
Eli Lilly and Company
03.2009 - 01.2011
Manager-Clinical Research
Eli Lilly and Company
07.2007 - 03.2009
Senior Clinical Research Associate
Novartis Pharmaceuticals
09.2005 - 07.2007
Clinical Research Associate
Reliance Clinical Research Services
07.2004 - 09.2005
Resident Doctor
N.D.M.C Charak Palika Hospital
01.2004 - 06.2004
Resident Doctor
Safdarjung Hospital
08.2003 - 01.2004
MBA - General Management
Indian Institute of Management
M.B.B.S - General Medicine
University of Mumbai
XIIth -
G. B Sr. Sec. School
Xth -
G.B Sr. Sec. School
Certification in Clinical Research -
Royal College of Physician
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