Mayur Kherdikar
Drug Developer
Panjim
Summary
Proactive, performance-driven drug developer with overall 15 years of experience various areas of drug development such as program/project management, clinical operations and medical writing. Experienced across all major therapeutic areas (Cardiovascular metabolism, respiratory, neurosciences Infectious/immunological diseases and Oncology). Recognized as a strong/impactful performer in all the functions/ teams . Contributed to various global and local (site level) innovation/ process improvements, capability building and organizational culture building initiatives
Overview
15
15
years of professional experience
9
9
years of post-secondary education
Work History
Associate Global Trial Director
Novartis
Hyderabad
12.2017 - Current
- Currently leading largest phase III clinical trial including 15,000 pts ever conducted by Novartis. Through agile and rapid planning of start-up activities achieved FPFV two months ahead of the schedule. Recognized with Development Star Award for the excellent leadership
- Led planning and implementation of novel hybrid operational model in partnership with a vendor for key Phase III clinical trial
- Led largest non-interventional study ever conducted by Novartis for multiple sclerosis through maintenance, database lock and submission activities; achieving high quality submission on time.
- Overall led more than 10 Phase II/III clinical studies across therapeutic areas from protocol preparation to study report preparation and submission.
- Complete oversight of budget and resource allocation for assigned trial. For the currently Phase III study managing the total budget of 350mUSD and yearly forecast of ~50-60mUSD
- Actively listened to customers, handled concerns quickly and escalated major issues to supervisor
Senior Project Manager
Novartis
Hyderabad
05.2014 - 11.2017
- Supported Program Head and program team members in translating program strategy into a clear operational project plans for high value and priority assets for the enterprise
- Managed yearly and long term budget planning (3 year); forecasting for various drug development projects with yearly budget in the range of 30-50mioUSD and long term budget in range of 100 to 200mUSD.
- Developed project plans and managed project scope using methodologies to guide projects from conceptualization to implementation and maintenance in line with the program/brand strategy
Expert Clinical Manager
Novartis
Hyderabad
08.2011 - 04.2014
- Co-lead planning, execution, reporting and close out of multiple Phase III global multi-centric clinical trials
- Delivered two pivotal phase III studies for diabetes product for China submission ahead of schedule.
Senior Medical Writer
Novartis
Hyderabad
09.2007 - 08.2011
- Medical writing team lead : Led team of medical writers for delivery clinical study reports for assigned portfolio
- Experienced in writing Phase I-III clinical study reports (CSRs) and various program level documents (e.g. annual safety update reports, investigator brochure)
- Led ~ more than 20 patient narrative writing projects across therapeutic areas, involving Project Management & co-ordination activities and also training and mentoring of the team members
Education
Master of Science - Pharmaceutical Medicine
Hibernia University
Dublin 05.2014 - 05.2016
Master of Science - Clinical Research
Institute of Clinical Research, Cranfield Uni.
Mumbai 09.2005 - 09.2007
Bachelor of Dentistry - Dental Sciences
Maharashtra University of Health Sciences
Nashik 07.2000 - 07.2005
Skills
Project Management
Accomplishments
- Awarded Development STAR award for the rapid start-up of largest cardio-vascular outcome study set-up by Novartis
- Awarded Galaxy team award for database lock, close-out and submission for the largest non-interventional program in multiple sclerosis
- Awarded and Recognized by the Global Program Head for my leadership in delivery of the critical milestones (health authority submission for pediatric clinical study)
- ABOVE and BEYOND Ovation awards for
- Onboarding and mentoring of the new new associates
- Roll-out of operational strategy for biomarker samples in clinical trial
Timeline
Associate Global Trial Director
Novartis
12.2017 - Current
Senior Project Manager
Novartis
05.2014 - 11.2017
Master of Science - Pharmaceutical Medicine
Hibernia University
05.2014 - 05.2016
Expert Clinical Manager
Novartis
08.2011 - 04.2014
Senior Medical Writer
Novartis
09.2007 - 08.2011
Master of Science - Clinical Research
Institute of Clinical Research, Cranfield Uni.
09.2005 - 09.2007
Bachelor of Dentistry - Dental Sciences
Maharashtra University of Health Sciences
07.2000 - 07.2005
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