Kanhaiya Poddar MD MS
Physician | Scientist | Medical Affairs
Cleveland,OH
Summary
Experienced Cardiovascular Physician with over a decade of global clinical, Medical Affairs, and research experiences, including five years related to Class III medical devices. Proficient in conducting and leading clinical research, with a focus on drug and device development, scientific communication, safety, and FDA/regulatory submission strategy. Skilled at collaborating with physicians across departments to achieve positive outcomes.
Overview
18
18
years of professional experience
1
1
Certification
3
3
Languages
Work History
Principal Clinical Research Scientist
Johnson & Johnson MedTech / Abiomed
05.2023 - Current
- Strategize protocol development for Pilot/Pivotal Study
- Lead the preparation and submission of FDA PMA CSR and other relevant regulatory submissions
- Clinical Lead for product registration with national regulatory agencies
- Pioneer the development of Clinical Evidence and Generation Plan
- Lead publication initiatives leveraging internal Registry Data and external Real World Evidence Data
Medical Affairs Manager
Abiomed
04.2019 - 04.2023
- Lead the literature surveillance to proactively prioritize, identify, assess, and critically summarize relevant scientific and medical literature across therapeutic area
- Finalize the clinical safety data submitted to regulatory agencies
- Partner with KOL for scientific research and and publishing manuscripts
- Represent Medical Affairs at medical and promotional review meetings
- Expert medical review of external facing, marketing, scientific and communication content to ensure scientific/medical accuracy, compliance, and consistency with company strategy
Outcomes Research, Research Fellow
Cleveland Clinic
05.2017 - 08.2018
- Manage the full spectrum of the clinical trial process including recruitment and managing clinical follow-up, imaging, regulatory compliance, internal quality assessment, adherence to protocol, and monitoring of different methods during a clinical trial as per protocol and GCP guidelines
- Collaborate with the CRO for the smooth functioning of the clinical trial, maintaining a comprehensive focus on safety, regulations, and scientific principles
- Manage submission of all necessary regulatory documents related to the studies, identification of AE, and documentation
- Increased clinical trial enrollment by more than 100% during the tenure
HealthCare Consultant
Somatus
03.2017 - 08.2017
- Developed market analysis strategy for nationwide expansion of the company
- Strategized the expansion of the company down to the county and city level through dedicated qualitative and quantitative analysis
- Identified future challenges associated with the market expansion and provided solutions.
Research Fellow
Cleveland Clinic
01.2011 - 01.2017
- Published extensively in high impact interventional cardiology journals, and presented abstracts at major scientific conferences
- Implemented and managed clinical research projects related to cardiovascular drug and devices, including working on cardiovascular research protocols for upcoming research studies
- Led the research of relevant literature, managing and analyzing clinical data using sophisticated statistical modeling, and data interpretion
- Analyzed cardiovascular images publication of scientific articles in renowned peer-reviewed journals, as well as authoring book chapters and abstracts
- Complex data management, research software development, and independent statistical analysis including regression models, propensity score matching, and other complex analysis
International Research Fellow
Guro Hospital, Korea University
06.2008 - 01.2011
- Systemized the data management structure at the cardiovascular department to assimilate data from the institution with the nationwide cardiovascular database registry, Korean Acute Myocardial Registry (KAMIR), increasing institutional efficiency
- Published and presented numerous abstracts along with 15 peer-reviewed publications on interventional cardiology research
- Developed in-depth familiarity with advanced methods in data analysis, data management, statistical analysis, and research methodology, as well as assisting in clinical procedures and cardiovascular imaging procedures as necessary.
Senior House Officer
B M Birla Heart Research Center
09.2006 - 04.2008
- Training in cardiovascular and peripheral vascular disease management, perform and analyze cardiovascular procedures such as EKG, Echocardiography, TMT, and others
- Managed emergency patients with emphasis on cardiovascular disease treatment, providing top-quality care with a focus on positive patient health outcomes
- Independently managed patients in the Coronary Care Unit (CCU), using comprehensive understanding of coronary issues and care to stabilize critical cases and formulate treatment plans
Education
Master of Science in Healthcare Management - Business Management
Johns Hopkins Carey Business School
BaltimoreMaster of Medical Science in Clinical Research - Medical Science
Korea University
South KoreaPost Graduate Diploma in Clinical Cardiology -
B M Birla Heart Research Centre
Kolkata, IndiaBachelor of Medicine and Surgery (License to Practice Medicine; equivalent to MD) -
Calcutta University
Kolkata, IndiaSkills
Medical Affairs
Certification
Licensed MD
Timeline
Principal Clinical Research Scientist
Johnson & Johnson MedTech / Abiomed
05.2023 - Current
Medical Affairs Manager
Abiomed
04.2019 - 04.2023
Outcomes Research, Research Fellow
Cleveland Clinic
05.2017 - 08.2018
HealthCare Consultant
Somatus
03.2017 - 08.2017
Research Fellow
Cleveland Clinic
01.2011 - 01.2017
International Research Fellow
Guro Hospital, Korea University
06.2008 - 01.2011
Senior House Officer
B M Birla Heart Research Center
09.2006 - 04.2008
Licensed MD
Master of Science in Healthcare Management - Business Management
Johns Hopkins Carey Business School
Master of Medical Science in Clinical Research - Medical Science
Korea University
Post Graduate Diploma in Clinical Cardiology -
B M Birla Heart Research Centre
Bachelor of Medicine and Surgery (License to Practice Medicine; equivalent to MD) -
Calcutta University
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