Vimal V.

Founder/Member Board Of Directors at Innovspace - Business Solutions/Coworking
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Contact Information
us****@****om
(386) 825-5501
Languages
  • English Native or bilingual proficiency
  • Tamil Native or bilingual proficiency
  • Kannada Native or bilingual proficiency

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Krishnakumar Rangaswamy

I recall Deuteronomy Rabbah - "In vain have you acquired knowledge if you have not imparted it to others", I am very impressed with Dr Vimal not because of his depth of knowledge and experience in the advanced fields of Science but because of his eagerness to share with the Youth. One of the best example of "Brain Gain", We Coimbatorians look forward to leap into the Global Science World with Dr Vimal's Stewardship

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Credentials

  • RAC
    Regulatory Affairs Professionals Society (RAPS)

Experience

    • India
    • Business Consulting and Services
    • 1 - 100 Employee
    • Founder/Member Board Of Directors
      • Feb 2017 - Present

      As the visionary Founder of Innovspace, I broke new ground by launching the first-ever coworking space in Coimbatore, a tier-two region. My innovative approach has revolutionized workspace solutions in an underserved market, setting a new standard for quality and accessibility. With a keen eye for strategic planning, location selection, and aesthetic design, I've cultivated a thriving community of freelancers, remote workers, and small businesses. My leadership extends beyond daily operations… Show more As the visionary Founder of Innovspace, I broke new ground by launching the first-ever coworking space in Coimbatore, a tier-two region. My innovative approach has revolutionized workspace solutions in an underserved market, setting a new standard for quality and accessibility. With a keen eye for strategic planning, location selection, and aesthetic design, I've cultivated a thriving community of freelancers, remote workers, and small businesses. My leadership extends beyond daily operations to encompass data-driven marketing and financial stewardship. By adeptly navigating market challenges and leveraging unique opportunities, I've positioned Innovspace as a leader in the coworking industry Show less As the visionary Founder of Innovspace, I broke new ground by launching the first-ever coworking space in Coimbatore, a tier-two region. My innovative approach has revolutionized workspace solutions in an underserved market, setting a new standard for quality and accessibility. With a keen eye for strategic planning, location selection, and aesthetic design, I've cultivated a thriving community of freelancers, remote workers, and small businesses. My leadership extends beyond daily operations… Show more As the visionary Founder of Innovspace, I broke new ground by launching the first-ever coworking space in Coimbatore, a tier-two region. My innovative approach has revolutionized workspace solutions in an underserved market, setting a new standard for quality and accessibility. With a keen eye for strategic planning, location selection, and aesthetic design, I've cultivated a thriving community of freelancers, remote workers, and small businesses. My leadership extends beyond daily operations to encompass data-driven marketing and financial stewardship. By adeptly navigating market challenges and leveraging unique opportunities, I've positioned Innovspace as a leader in the coworking industry Show less

    • United States
    • Biotechnology Research
    • 1 - 100 Employee
    • Sr. Director, GCP/ PV
      • Dec 2022 - Present

      As a seasoned Head of Clinical QA, my leadership is defined by a robust technical acumen and a strategic approach to quality assurance in Good Clinical Practice (GCP), Pharmacovigilance (PV), and Computer System Validation (CSV). I spearhead cross-functional teams, instilling a culture of excellence and compliance aligned with ICH guidelines, FDA regulations, and EMA standards. My leadership skills extend to risk-based auditing, CAPA management, and SOP development, ensuring that we meet and… Show more As a seasoned Head of Clinical QA, my leadership is defined by a robust technical acumen and a strategic approach to quality assurance in Good Clinical Practice (GCP), Pharmacovigilance (PV), and Computer System Validation (CSV). I spearhead cross-functional teams, instilling a culture of excellence and compliance aligned with ICH guidelines, FDA regulations, and EMA standards. My leadership skills extend to risk-based auditing, CAPA management, and SOP development, ensuring that we meet and exceed industry benchmarks. With a focus on data integrity, patient safety, and regulatory compliance, I have successfully led initiatives that have elevated the quality of clinical development. Show less As a seasoned Head of Clinical QA, my leadership is defined by a robust technical acumen and a strategic approach to quality assurance in Good Clinical Practice (GCP), Pharmacovigilance (PV), and Computer System Validation (CSV). I spearhead cross-functional teams, instilling a culture of excellence and compliance aligned with ICH guidelines, FDA regulations, and EMA standards. My leadership skills extend to risk-based auditing, CAPA management, and SOP development, ensuring that we meet and… Show more As a seasoned Head of Clinical QA, my leadership is defined by a robust technical acumen and a strategic approach to quality assurance in Good Clinical Practice (GCP), Pharmacovigilance (PV), and Computer System Validation (CSV). I spearhead cross-functional teams, instilling a culture of excellence and compliance aligned with ICH guidelines, FDA regulations, and EMA standards. My leadership skills extend to risk-based auditing, CAPA management, and SOP development, ensuring that we meet and exceed industry benchmarks. With a focus on data integrity, patient safety, and regulatory compliance, I have successfully led initiatives that have elevated the quality of clinical development. Show less

    • India
    • Hospitals and Health Care
    • 200 - 300 Employee
    • Vice Chairperson, Institutional Ethics Commitee
      • Jun 2018 - Jan 2023

      As the Vice Chairperson of the Institutional Ethics Committee, I bring a blend of ethical rigor and clinical expertise to oversee the integrity of clinical trials. My leadership is pivotal in ensuring compliance with ethical standards, informed consent processes, and regulatory guidelines. With a focus on patient safety and data validity, I collaborate with cross-functional teams to review and approve trial protocols, monitor ongoing studies, and evaluate adverse events. My role is instrumental… Show more As the Vice Chairperson of the Institutional Ethics Committee, I bring a blend of ethical rigor and clinical expertise to oversee the integrity of clinical trials. My leadership is pivotal in ensuring compliance with ethical standards, informed consent processes, and regulatory guidelines. With a focus on patient safety and data validity, I collaborate with cross-functional teams to review and approve trial protocols, monitor ongoing studies, and evaluate adverse events. My role is instrumental in upholding the ethical principles that guide clinical research, making a significant impact on both patient outcomes and scientific validity. Show less As the Vice Chairperson of the Institutional Ethics Committee, I bring a blend of ethical rigor and clinical expertise to oversee the integrity of clinical trials. My leadership is pivotal in ensuring compliance with ethical standards, informed consent processes, and regulatory guidelines. With a focus on patient safety and data validity, I collaborate with cross-functional teams to review and approve trial protocols, monitor ongoing studies, and evaluate adverse events. My role is instrumental… Show more As the Vice Chairperson of the Institutional Ethics Committee, I bring a blend of ethical rigor and clinical expertise to oversee the integrity of clinical trials. My leadership is pivotal in ensuring compliance with ethical standards, informed consent processes, and regulatory guidelines. With a focus on patient safety and data validity, I collaborate with cross-functional teams to review and approve trial protocols, monitor ongoing studies, and evaluate adverse events. My role is instrumental in upholding the ethical principles that guide clinical research, making a significant impact on both patient outcomes and scientific validity. Show less

    • United States
    • Biotechnology Research
    • 1 - 100 Employee
    • Director
      • Dec 2021 - Dec 2022

      As the Director of Clinical Quality at Arcellx, a leader in the cell therapy oncology domain, I've set new standards for leadership in Clinical QA. My technical acumen and strategic approach have been instrumental in advancing Good Clinical Practice (GCP), Pharmacovigilance (PV), and Computer System Validation (CSV) within the organization. Leading cross-functional teams, I've instilled a culture of excellence and compliance that aligns with ICH guidelines, FDA regulations, and EMA standards… Show more As the Director of Clinical Quality at Arcellx, a leader in the cell therapy oncology domain, I've set new standards for leadership in Clinical QA. My technical acumen and strategic approach have been instrumental in advancing Good Clinical Practice (GCP), Pharmacovigilance (PV), and Computer System Validation (CSV) within the organization. Leading cross-functional teams, I've instilled a culture of excellence and compliance that aligns with ICH guidelines, FDA regulations, and EMA standards. My specialized skills in risk-based auditing, CAPA management, and SOP development have not only met but exceeded industry benchmarks. With a steadfast commitment to data integrity, patient safety, and regulatory compliance, I've successfully elevated the quality of Arcellx's clinical development in the highly specialized field of cell therapy oncology Show less As the Director of Clinical Quality at Arcellx, a leader in the cell therapy oncology domain, I've set new standards for leadership in Clinical QA. My technical acumen and strategic approach have been instrumental in advancing Good Clinical Practice (GCP), Pharmacovigilance (PV), and Computer System Validation (CSV) within the organization. Leading cross-functional teams, I've instilled a culture of excellence and compliance that aligns with ICH guidelines, FDA regulations, and EMA standards… Show more As the Director of Clinical Quality at Arcellx, a leader in the cell therapy oncology domain, I've set new standards for leadership in Clinical QA. My technical acumen and strategic approach have been instrumental in advancing Good Clinical Practice (GCP), Pharmacovigilance (PV), and Computer System Validation (CSV) within the organization. Leading cross-functional teams, I've instilled a culture of excellence and compliance that aligns with ICH guidelines, FDA regulations, and EMA standards. My specialized skills in risk-based auditing, CAPA management, and SOP development have not only met but exceeded industry benchmarks. With a steadfast commitment to data integrity, patient safety, and regulatory compliance, I've successfully elevated the quality of Arcellx's clinical development in the highly specialized field of cell therapy oncology Show less

    • United States
    • Software Development
    • Member Board Of Directors
      • Jan 2021 - Nov 2022

      As the visionary Founder of Zita.ai, I conceptualized an AI-powered recruitment platform aimed at transforming the hiring landscape. While the idea was mine, its successful execution has been led by a high-caliber team that I've personally groomed. Together, we've developed a platform that modernizes and simplifies recruitment through essential ATS features and cutting-edge AI algorithms. My leadership has been instrumental not only in ideation but also in cultivating a team that has turned… Show more As the visionary Founder of Zita.ai, I conceptualized an AI-powered recruitment platform aimed at transforming the hiring landscape. While the idea was mine, its successful execution has been led by a high-caliber team that I've personally groomed. Together, we've developed a platform that modernizes and simplifies recruitment through essential ATS features and cutting-edge AI algorithms. My leadership has been instrumental not only in ideation but also in cultivating a team that has turned this vision into a reality, setting new industry standards for efficiency and effectiveness in talent acquisition. Show less As the visionary Founder of Zita.ai, I conceptualized an AI-powered recruitment platform aimed at transforming the hiring landscape. While the idea was mine, its successful execution has been led by a high-caliber team that I've personally groomed. Together, we've developed a platform that modernizes and simplifies recruitment through essential ATS features and cutting-edge AI algorithms. My leadership has been instrumental not only in ideation but also in cultivating a team that has turned… Show more As the visionary Founder of Zita.ai, I conceptualized an AI-powered recruitment platform aimed at transforming the hiring landscape. While the idea was mine, its successful execution has been led by a high-caliber team that I've personally groomed. Together, we've developed a platform that modernizes and simplifies recruitment through essential ATS features and cutting-edge AI algorithms. My leadership has been instrumental not only in ideation but also in cultivating a team that has turned this vision into a reality, setting new industry standards for efficiency and effectiveness in talent acquisition. Show less

    • United States
    • Biotechnology Research
    • 1 - 100 Employee
    • Director, Clinical Quality
      • Jun 2019 - Nov 2021

      As the Director of Clinical Quality, I led the organization to a landmark achievement—the successful approval of the breakthrough drug Mavacampten. Leveraging technical expertise in Good Clinical Practice (GCP), Pharmacovigilance (PV), and Computer System Validation (CSV), I implemented risk-based auditing and CAPA management strategies that exceeded regulatory standards. My collaborative leadership united cross-functional teams and streamlined processes, resulting in accelerated timelines and… Show more As the Director of Clinical Quality, I led the organization to a landmark achievement—the successful approval of the breakthrough drug Mavacampten. Leveraging technical expertise in Good Clinical Practice (GCP), Pharmacovigilance (PV), and Computer System Validation (CSV), I implemented risk-based auditing and CAPA management strategies that exceeded regulatory standards. My collaborative leadership united cross-functional teams and streamlined processes, resulting in accelerated timelines and impeccable data integrity. This culminated in meeting and surpassing compliance benchmarks, setting a new industry standard for clinical trial excellence. Show less As the Director of Clinical Quality, I led the organization to a landmark achievement—the successful approval of the breakthrough drug Mavacampten. Leveraging technical expertise in Good Clinical Practice (GCP), Pharmacovigilance (PV), and Computer System Validation (CSV), I implemented risk-based auditing and CAPA management strategies that exceeded regulatory standards. My collaborative leadership united cross-functional teams and streamlined processes, resulting in accelerated timelines and… Show more As the Director of Clinical Quality, I led the organization to a landmark achievement—the successful approval of the breakthrough drug Mavacampten. Leveraging technical expertise in Good Clinical Practice (GCP), Pharmacovigilance (PV), and Computer System Validation (CSV), I implemented risk-based auditing and CAPA management strategies that exceeded regulatory standards. My collaborative leadership united cross-functional teams and streamlined processes, resulting in accelerated timelines and impeccable data integrity. This culminated in meeting and surpassing compliance benchmarks, setting a new industry standard for clinical trial excellence. Show less

    • United States
    • Information Technology & Services
    • 1 - 100 Employee
    • Member Board Of Directors
      • Jan 2018 - Jul 2021

      As the Founder and Member of the Board of Sense7AI, I've been instrumental in steering the company's vision and strategy for delivering innovative, intelligent software solutions. My dual role allows me to blend entrepreneurial drive with governance oversight, ensuring not only the commercial success of our products but also long-term sustainability. Specializing in everything from digital product strategy to data analytics and UX design, I've led Sense7AI from concept to commercialization… Show more As the Founder and Member of the Board of Sense7AI, I've been instrumental in steering the company's vision and strategy for delivering innovative, intelligent software solutions. My dual role allows me to blend entrepreneurial drive with governance oversight, ensuring not only the commercial success of our products but also long-term sustainability. Specializing in everything from digital product strategy to data analytics and UX design, I've led Sense7AI from concept to commercialization, empowering businesses to stay ahead of technological trends. My leadership is characterized by strategic acumen, operational excellence, and a keen focus on measurable outcomes, setting a high standard in the industry. Show less As the Founder and Member of the Board of Sense7AI, I've been instrumental in steering the company's vision and strategy for delivering innovative, intelligent software solutions. My dual role allows me to blend entrepreneurial drive with governance oversight, ensuring not only the commercial success of our products but also long-term sustainability. Specializing in everything from digital product strategy to data analytics and UX design, I've led Sense7AI from concept to commercialization… Show more As the Founder and Member of the Board of Sense7AI, I've been instrumental in steering the company's vision and strategy for delivering innovative, intelligent software solutions. My dual role allows me to blend entrepreneurial drive with governance oversight, ensuring not only the commercial success of our products but also long-term sustainability. Specializing in everything from digital product strategy to data analytics and UX design, I've led Sense7AI from concept to commercialization, empowering businesses to stay ahead of technological trends. My leadership is characterized by strategic acumen, operational excellence, and a keen focus on measurable outcomes, setting a high standard in the industry. Show less

    • United States
    • Biotechnology Research
    • 700 & Above Employee
    • Strategy Lead - Clinical Quality Assurance & Risk Management
      • Dec 2008 - Jun 2015

      As the Strategy Lead for Clinical Quality Assurance & Risk Management, my standout achievement has been the successful implementation of a robust Quality Management System (QMS) during the early development phase at gRED. Specializing in quality risk management, I've pioneered risk-based auditing and risk-based monitoring guidance. A significant milestone under my leadership was the creation of analytics for audit data, which has been instrumental in providing key metrics and KPIs for our… Show more As the Strategy Lead for Clinical Quality Assurance & Risk Management, my standout achievement has been the successful implementation of a robust Quality Management System (QMS) during the early development phase at gRED. Specializing in quality risk management, I've pioneered risk-based auditing and risk-based monitoring guidance. A significant milestone under my leadership was the creation of analytics for audit data, which has been instrumental in providing key metrics and KPIs for our annual report. These analytics have enhanced our understanding of compliance levels, risk profiles, and operational efficiencies. My initiatives have not only ensured adherence to Good Clinical Practice (GCP), Pharmacovigilance (PV), and Computer System Validation (CSV) but have also set new benchmarks for quality and risk management in the industry. Show less As the Strategy Lead for Clinical Quality Assurance & Risk Management, my standout achievement has been the successful implementation of a robust Quality Management System (QMS) during the early development phase at gRED. Specializing in quality risk management, I've pioneered risk-based auditing and risk-based monitoring guidance. A significant milestone under my leadership was the creation of analytics for audit data, which has been instrumental in providing key metrics and KPIs for our… Show more As the Strategy Lead for Clinical Quality Assurance & Risk Management, my standout achievement has been the successful implementation of a robust Quality Management System (QMS) during the early development phase at gRED. Specializing in quality risk management, I've pioneered risk-based auditing and risk-based monitoring guidance. A significant milestone under my leadership was the creation of analytics for audit data, which has been instrumental in providing key metrics and KPIs for our annual report. These analytics have enhanced our understanding of compliance levels, risk profiles, and operational efficiencies. My initiatives have not only ensured adherence to Good Clinical Practice (GCP), Pharmacovigilance (PV), and Computer System Validation (CSV) but have also set new benchmarks for quality and risk management in the industry. Show less

    • United States
    • Higher Education
    • 700 & Above Employee
    • Clinical Scientist | Regulatory Affairs Project Manager
      • Dec 2006 - Dec 2008

      As a Clinical Project Manager and Regulatory Liaison, I have extensive experience in transitioning projects from bench research to clinical stage, including specialized work in CD34 stem cell therapy for cardiovascular regenerative medicine and bench-side research in neurodegeneration. My role encompasses comprehensive oversight of project management, regulatory affairs, and clinical research, including IND submissions, protocol development, and the submission of annual and safety reports. My… Show more As a Clinical Project Manager and Regulatory Liaison, I have extensive experience in transitioning projects from bench research to clinical stage, including specialized work in CD34 stem cell therapy for cardiovascular regenerative medicine and bench-side research in neurodegeneration. My role encompasses comprehensive oversight of project management, regulatory affairs, and clinical research, including IND submissions, protocol development, and the submission of annual and safety reports. My multidisciplinary expertise has been crucial in ensuring seamless transitions and compliance with industry and regulatory standards. My leadership has been key in meeting project milestones, navigating the complexities of regulatory submissions, and maintaining the integrity of clinical trials Show less As a Clinical Project Manager and Regulatory Liaison, I have extensive experience in transitioning projects from bench research to clinical stage, including specialized work in CD34 stem cell therapy for cardiovascular regenerative medicine and bench-side research in neurodegeneration. My role encompasses comprehensive oversight of project management, regulatory affairs, and clinical research, including IND submissions, protocol development, and the submission of annual and safety reports. My… Show more As a Clinical Project Manager and Regulatory Liaison, I have extensive experience in transitioning projects from bench research to clinical stage, including specialized work in CD34 stem cell therapy for cardiovascular regenerative medicine and bench-side research in neurodegeneration. My role encompasses comprehensive oversight of project management, regulatory affairs, and clinical research, including IND submissions, protocol development, and the submission of annual and safety reports. My multidisciplinary expertise has been crucial in ensuring seamless transitions and compliance with industry and regulatory standards. My leadership has been key in meeting project milestones, navigating the complexities of regulatory submissions, and maintaining the integrity of clinical trials Show less

    • United States
    • Higher Education
    • 500 - 600 Employee
    • Clinical Project Manager & Sr. Researcher
      • Jul 2004 - Dec 2006

      As a Sr. Scientist, I've spearheaded clinical operations and regulatory affairs across a diverse portfolio of clinical programs. My leadership has been instrumental in advancing Phase I & II clinical trials in cardiovascular diseases such as CHF and CAD, as well as vascular diseases like CLI and PAD, leveraging cutting-edge Gene Therapy and Stem Cell research. In addition, my involvement in bench research for neurodegeneration has led to multiple publications in areas like Alzheimer's… Show more As a Sr. Scientist, I've spearheaded clinical operations and regulatory affairs across a diverse portfolio of clinical programs. My leadership has been instrumental in advancing Phase I & II clinical trials in cardiovascular diseases such as CHF and CAD, as well as vascular diseases like CLI and PAD, leveraging cutting-edge Gene Therapy and Stem Cell research. In addition, my involvement in bench research for neurodegeneration has led to multiple publications in areas like Alzheimer's, Parkinson's, and Inclusion body myositis. My role has been pivotal in IND submissions, protocol development, and the submission of annual and safety reports, setting new benchmarks for clinical and regulatory excellence. Show less As a Sr. Scientist, I've spearheaded clinical operations and regulatory affairs across a diverse portfolio of clinical programs. My leadership has been instrumental in advancing Phase I & II clinical trials in cardiovascular diseases such as CHF and CAD, as well as vascular diseases like CLI and PAD, leveraging cutting-edge Gene Therapy and Stem Cell research. In addition, my involvement in bench research for neurodegeneration has led to multiple publications in areas like Alzheimer's… Show more As a Sr. Scientist, I've spearheaded clinical operations and regulatory affairs across a diverse portfolio of clinical programs. My leadership has been instrumental in advancing Phase I & II clinical trials in cardiovascular diseases such as CHF and CAD, as well as vascular diseases like CLI and PAD, leveraging cutting-edge Gene Therapy and Stem Cell research. In addition, my involvement in bench research for neurodegeneration has led to multiple publications in areas like Alzheimer's, Parkinson's, and Inclusion body myositis. My role has been pivotal in IND submissions, protocol development, and the submission of annual and safety reports, setting new benchmarks for clinical and regulatory excellence. Show less

    • Germany
    • Research Services
    • 700 & Above Employee
    • Scientist - Metabolism and Toxicokinetics
      • Jan 2001 - Jul 2004

      As a Scientist specializing in Metabolism and Toxicokinetics, I've been a key collaborator within a multidisciplinary research team, working closely with industry partners. My contributions have been groundbreaking in the field of high-throughput toxicokinetics, where I've been involved in both mathematical and experimental modeling. I've successfully generated and validated new models, setting new standards for accuracy and reliability in the field. My work has not only advanced our… Show more As a Scientist specializing in Metabolism and Toxicokinetics, I've been a key collaborator within a multidisciplinary research team, working closely with industry partners. My contributions have been groundbreaking in the field of high-throughput toxicokinetics, where I've been involved in both mathematical and experimental modeling. I've successfully generated and validated new models, setting new standards for accuracy and reliability in the field. My work has not only advanced our understanding of toxicokinetics but has also been recognized through co-authored research papers, underscoring my commitment to scientific excellence and collaborative research. Show less As a Scientist specializing in Metabolism and Toxicokinetics, I've been a key collaborator within a multidisciplinary research team, working closely with industry partners. My contributions have been groundbreaking in the field of high-throughput toxicokinetics, where I've been involved in both mathematical and experimental modeling. I've successfully generated and validated new models, setting new standards for accuracy and reliability in the field. My work has not only advanced our… Show more As a Scientist specializing in Metabolism and Toxicokinetics, I've been a key collaborator within a multidisciplinary research team, working closely with industry partners. My contributions have been groundbreaking in the field of high-throughput toxicokinetics, where I've been involved in both mathematical and experimental modeling. I've successfully generated and validated new models, setting new standards for accuracy and reliability in the field. My work has not only advanced our understanding of toxicokinetics but has also been recognized through co-authored research papers, underscoring my commitment to scientific excellence and collaborative research. Show less

Education

  • Northwestern University
    Project Management, Medical Clinical Sciences/Graduate Medical Studies
    2008 - 2008
  • Regulatory Affairs Professional Society
    Regulatory Affiars Certification, USFDA and Global Strategy, Pharmacy Administration and Pharmacy Policy and Regulatory Affairs
    2004 -
  • University of Madras
    PhD, Biochemistry
    1999 - 2001

Community

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