Kiran Chatha
Miami,USA
Summary
Dynamic Associate Medical Director at DermaSensor Inc, skilled in clinical strategy and regulatory submissions. Proven track record in manuscript preparation and cross-functional collaboration, leading to successful FDA applications and breakthrough designations. Passionate about driving business growth through strategic planning and team leadership, fostering strong relationships with key opinion leaders.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Associate Medical Director
DermaSensor Inc
08.2024 - Current
- Responsible for developing and executing medical affairs strategy to support the continued development and commercialization of the DermaSensor device.
- Responsible for contributing to clinical strategy (including sponsored studies and investigator initiated trials), supporting regulatory activities (including presubmissions to the FDA for pipeline projects) and medical affairs activities (including publication planning, publication execution, management of vendors, KOL engagement strategy and conference planning).
- Worked collaboratively across cross-functional teams with internal and external stakeholders including clinical investigators, regulatory agencies and commercial teams.
Clinical and Medical Science Liaison
DermaSensor Inc
01.2022 - 08.2024
- Responsible for literature review, developing research reports and presenting information on relevant similar devices, diagnostic techniques and treatments related to skin cancer detection and management.
- Provide medical and scientific guidance on developing clinical studies, create post market clinical study plans and protocols, assist with coordinating with physicians and writers for planning, writing and publication.
- Responsible for providing expertise and guidance for promotional materials, manuscript preparation, study set up, post market study planning.
- Supported Director of Medical Affairs in collaborating with field experts in study and publication development.
- Supported reporting to the FDA, EU and Australian regulatory bodies, overseeing and collaborating with biostatistical experts.
- Attended multiple national, regional and local conferences collecting relevant insights from KOLs.
- Developed and maintained relationships with multiple KOLs.
- Support publication of multiple manuscripts and posters for data dissemination purposes.
- Wrote and supported review of multiple clinical study reports and regulatory documentation to support FDA application.
- Responsible for creation of post market clinical study plans and protocols, engaging advisors for input.
- Developed understanding of payer approval process for garnering a CPT code for a device.
- Drafted Breakthrough designation application, awarded breakthrough designation Dec 2023.
Associate Clinical Writer Manager
Applied Medical
06.2021 - 01.2022
- Responsible for all general Clinical Writing responsibilities as well as mentoring junior Clinical writers, providing support with project management, reviewing clinical evaluation plans and reports, assisting with SOP development as well as updates.
- Manage a team of up to 4 Clinical Writers and 1 intern through their day-to-day activities.
- Trained new hires on the complete process of writing Clinical Evaluations to be compliant with MDR regulations for 2021 submissions.
- Worked closely with the product teams to evaluate whether new design changes would require updates to Clinical Evaluations.
- Worked closely with engineering and product development teams to provide background literature review and consultation for risks and benefits associated with potential new product development.
Clinical Consultant
DermaSensor Inc
06.2021 - 12.2021
- Responsible for providing expertise and guidance for clinical study design, statistical analysis and final manuscript preparation.
- Assisted with development of SOPs, manuscripts, SAPs, abstracts and other device and procedural documentation.
- Assisted with liaising with various stakeholders to provide information regarding the device and clinical applications.
- Assisted the executive team in approaching and liaising with KOLs on input for device use and efficacy.
- Assisted with clinical development plans regarding algorithm selection and optimization.
- Provided input on cross functional teams regarding marketing materials in patient and physician facing settings.
Clinical Writer
Applied Medical
10.2020 - 06.2021
- Responsible for preparing, editing and updating clinical evaluation plans and reports, post market surveillance plans, post market clinical follow-up studies as needed for various stages of development for surgical devices.
- Working with a team to prepare and update regulatory documentation and SOPs as needed.
- Review and update current documentation as well as provide background literature for product development documentation during risk assessment process.
- Familiarized myself with MEDDEV 2.7/1 Regulations for the MDR transition as well as being an expert resource for other teams (including Engineering and product development).
- Prepared and edited 5 complete Clinical Evaluation Reports for various minimally invasive surgical devices.
- Standardized feedback forms for field collection to generate data for clinical evaluations.
- Consulted with clinical development and engineering teams to develop clinical studies for new and existing product lines.
Clinical Research Coordinator, Levitetz Dept of Orthopedic Surgery
Cleveland Clinic Florida
10.2018 - 06.2020
- Company Overview: Cleveland Clinic Florida’s Orthopedic Surgery Department is one of the highest-ranking orthopedics providers in South Florida.
- I managed sponsored studies including FDA trials, sponsored investigator-initiated trials and approximately 20 internal projects during my funded research time.
- Lead and managed the lifecycle for 4 clinical trial protocols for devices and biologics in under 1 year, totaling over $2 million in funding from investigational device and drug sponsors.
- Worked closely with 3 principal investigators on developing internal research projects from protocol development with literature review through data collection, analysis and manuscript production.
- Standardized and implemented clinical data collection procedures using RedCAP for internal patient registries.
- Managed budget allocation and regulatory documents for sponsored studies.
- Completed internal feasibility checks for all internal investigator-initiated studies in conjunction with central database teams.
- Standardized protocol and ICF template for investigator-initiated studies including industry funded studies.
- Managed regulatory submissions with the Cleveland Clinic Florida Institutional Review Board (IRB).
- Managed a team of 8 medical students and 3 research fellows through the research process from protocol initiation through to manuscript production.
- Cleveland Clinic Florida’s Orthopedic Surgery Department is one of the highest-ranking orthopedics providers in South Florida.
Clinical Research Fellow, Levitetz Dept of Orthopedic Surgery
Cleveland Clinic Florida
03.2017 - 10.2018
- Company Overview: Cleveland Clinic Florida’s Sports and Shoulder Surgeon group is among the highest ranking in South Florida.
- Worked with Dr Gregory Gilot and Dr Vani Sabesan, both shoulder and sports surgeons on producing 20 manuscripts from study initiation through to manuscript submission and journal acceptance.
- Initiated, wrote, and managed a trial on opioid free shoulder surgery considering the opioid crisis and HB-21 regulations which was also submitted and received grant funding both internally and externally.
- Learned proficiency with statistical analysis using SPSS software platform.
- Presented research at the local, national, and international level with 21 podium presentations.
- Worked with a team of 3 other fellows in managing a RedCAP database for collecting clinical patient reported outcomes.
- Won the American Medical Association’s Best Abstract/Presentation Award on 2 occasions (Nov 2017, Oct 2018).
- Won Florida Orthopedic Society’s Best Presentation Award (Jun 2018).
- Cleveland Clinic Florida’s Sports and Shoulder Surgeon group is among the highest ranking in South Florida.
Research Project (Intern Research Project)
Larkin Hospital Department of General Surgery
11.2016 - 12.2016
- During a clinical rotation I worked on a unique research project looking at breast cancer prognosis and outcomes for a series of stage 4 patients undergoing a radical mastectomy.
- Researched and wrote up medical history for the patient.
- Completed literature review for stage 4 cancer prognosis and detailed treatment protocols.
- Completed poster and manuscript production with imaging analysis from pathology reports.
Education
Master of Science - Public Health
University of Liverpool
05-2020
M.D. - Medical Doctor
Trinity University School of Medicine
03-2016
Bachelor of Science - Biomedical Science
University of British Columbia
05-2012
Skills
- Clinical strategy and medical affairs
- Regulatory submissions and compliance
- Manuscript preparation and publication
- Cross-functional collaboration and teamwork
- Vendor management and partnerships
- Key opinion leader engagement and networking
- Conference planning and execution
- Team leadership and development
- Medical expertise and education
- Strategic planning and project management
- Clinical research and studies
- Business growth strategies
Accomplishments
- AMA National Presentation Competition Winner - 2018
- AMA National Poster Competition Winner - 2017
- Governor General's Academic Achievement Award - 2007
Languages
English
Native/ Bilingual
Punjabi
Professional
Spanish
Professional
Certification
- BLS/ACLS Certification - Expires 2027
- CITI Training - Expires 2026
Timeline
Associate Medical Director
DermaSensor Inc
08.2024 - Current
Clinical and Medical Science Liaison
DermaSensor Inc
01.2022 - 08.2024
Associate Clinical Writer Manager
Applied Medical
06.2021 - 01.2022
Clinical Consultant
DermaSensor Inc
06.2021 - 12.2021
Clinical Writer
Applied Medical
10.2020 - 06.2021
Clinical Research Coordinator, Levitetz Dept of Orthopedic Surgery
Cleveland Clinic Florida
10.2018 - 06.2020
Clinical Research Fellow, Levitetz Dept of Orthopedic Surgery
Cleveland Clinic Florida
03.2017 - 10.2018
Research Project (Intern Research Project)
Larkin Hospital Department of General Surgery
11.2016 - 12.2016
Master of Science - Public Health
University of Liverpool
M.D. - Medical Doctor
Trinity University School of Medicine
Bachelor of Science - Biomedical Science
University of British Columbia
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