Faisal Lodhi
Piscataway
Summary
Physician-trained Clinical Scientist with 20+ years of experience in clinical development, clinical research, and regulated healthcare environments. Proven track record supporting trial design, protocol development, site engagement, patient recruitment, safety monitoring, and data review across oncology, cardiovascular, gastroenterology, infectious disease, women’s health, and immunology-focused programs. Experienced in cross-functional collaboration with medical writing, clinical development, and operations teams to support study execution, protocol amendments, and high-quality clinical deliverables. Strong background in ICH-GCP, pharmacovigilance, and scientific review, with hands-on expertise in CAR-T and other advanced therapy environments.
Overview
25
25
years of professional experience
1
1
Certification
Work History
Cell Processing Specialist
CAR-T, Novartis
Morris Plains, NJ
02.2025 - Current
- Executed regulated CAR-T cell processing and T-cell isolation in compliance with cGMP standards, ensuring patient-derived cells were prepared for therapeutic use.
- Supported genetic modification processes to enhance CAR expression, maintaining rigorous documentation and adherence to regulatory requirements and GCP guidelines.
Clinical Scientist
Alpha Clinical Development
Piscataway, NJ
09.2023 - 02.2025
- Supported the design of clinical studies and development of endpoints in collaboration with cross-functional teams, ensuring adherence to regulatory requirements and ICH guidelines.
- Led the creation of the Medical Monitoring Plan, conducted thorough reviews of serious adverse event reports, and monitored data integrity through central lab evaluations.
- Provided scientific input for Safety Advisory Committees, Data Monitoring Committees, and adjudication committees, while enhancing data management processes including electronic data capture and case report form development.
- Authored and reviewed clinical trial protocols and amendments, including protocol clarification letters, and assessed protocol deviations for inclusion in clinical study reports.
- Mentored junior Clinical Scientists, fostering their professional development and enhancing team capabilities in clinical trial execution.
Revenue Cycle Analyst
Phoenix Health Management
Houston, TX
09.2021 - 09.2023
- Managed patient communications regarding procedural and safety inquiries, facilitating accurate information exchange and enhancing patient understanding.
- Collected and documented clinical and billing data, ensuring compliance with regulatory requirements and GCP guidelines.
- Conducted gap analyses to identify and resolve data discrepancies, contributing to the integrity of patient records.
Shift Supervisor (Part-Time)
CVS Health
Houston, TX
04.2021 - 09.2023
- Led patient education initiatives on medication safety and chronic disease management, improving patient understanding and adherence to treatment plans.
- Addressed patient inquiries with professionalism, enhancing service quality and fostering trust within the community.
Clinical Program Coordinator
Altus Hospital
Houston, TX
05.2018 - 04.2019
- Analyzed clinical outcomes to enhance treatment strategies, utilizing data analysis to identify patient response trends.
- Managed patient tracking and documentation, ensuring seamless continuity of care and adherence to regulatory requirements.
- Facilitated effective communication among physicians, administrative teams, and stakeholders to streamline operations.
- Optimized workflows through process improvement initiatives, leading to enhanced patient outcomes and compliance with GCP guidelines.
Product Specialist
Roche Pharmaceuticals
Jeddah, Saudi Arabia
01.2015 - 01.2016
- Supported communication of treatment related safety information through engagement with oncologists and healthcare providers.
- Facilitated discussions on therapy safety profiles and patient management considerations.
Product Specialist
3M Health Care
Jeddah, Saudi Arabia
01.2013 - 01.2015
- Led a multicenter clinical study on Tegaderm CHG IV dressings with over 1,200 patients, focusing on its effectiveness in reducing infections in oncology units.
- Achieved approximately 60% reduction in catheter-related bloodstream infections and eliminated central line-associated bloodstream infections through rigorous protocol adherence.
- Converted clinical outcomes into evidence-based value propositions, resulting in a successful government tender and exceeding revenue targets with $17M generated.
- Recognized with the Global Marketing Award for impactful contributions to clinical and commercial outcomes.
Product Manager – International Marketing
Organon Bio Sciences
Colombo, Sri Lanka
09.2011 - 06.2012
- Led the design and execution of a large-scale clinical program for the launch of Esomeprazole, focusing on GERD management and integrating clinical insights with strategic marketing.
- Engaged with gastroenterologists and specialists to facilitate the enrollment of over 1,000 patients, enhancing the program's reach and impact.
- Developed a cross-specialty strategy targeting physicians managing NSAID-induced GERD, ensuring comprehensive market coverage.
- Utilized real-world clinical insights and physician feedback to inform evidence-based positioning, contributing to a successful national product launch.
Regional Sales Manager
Hilton Pharma
Lagos, Nigeria
06.2010 - 09.2011
- Led a multicenter clinical study on Tranexamic Acid involving over 750 women with menorrhagia, resulting in a 65% reduction in heavy menstrual bleeding and supporting successful product positioning.
- Coordinated recruitment efforts with gynecologists and general practitioners, ensuring adherence to Clinical Trial Protocols and effective clinical monitoring.
- Developed and prepared regulatory documentation, facilitating product registration with NAFDAC and ensuring compliance with Regulatory Requirements and GCP Guidelines.
- Directed cross-functional team activities, enhancing collaboration among clinical, regulatory, and commercial teams to streamline the pre-launch clinical strategy.
Professional Sales Representative
Merck Sharp & Dohme
Jeddah, Saudi Arabia
02.2004 - 01.2009
- Supported a clinical study on Simvastatin for high-risk dyslipidemia patients, collaborating with cardiologists, neurologists, and internal medicine physicians to enhance treatment strategies.
- Facilitated patient recruitment by engaging over 25 physicians, ensuring adherence to clinical trial protocols across multiple sites.
- Analyzed clinical data, contributing to a ~40% reduction in stroke risk among participants.
- Monitored safety and documented adverse events for over 900 patients as part of a pharmacovigilance project.
Clinical Research Physician
Jinnah Postgraduate Medical Centre
Karachi, Pakistan
09.2001 - 02.2004
- Led interventional and observational clinical studies, ensuring compliance with GCP guidelines and maintaining scientific integrity.
- Conducted clinical data analysis and safety monitoring, collaborating with cross-functional teams to enhance study execution.
- Developed and coordinated multiple clinical research studies, including establishing protocols and informed consents, gathering data from patient charts, recruiting and enrolling study participants, tabulating research data, recording results of experiments, preparing research manuscripts and research-presentations, and developing and maintaining research databases.
Education
Master of Science - EP, Heart & Pacemaker
University of Texas McGovern Medical School
01-2019
Postgraduate Diploma - Clinical Research & GCP
James Lind Institute
01-2015
Diploma - Sales & Marketing
Skill Development Council of Pakistan
01-2013
MD (Doctor of Medicine) - undefined
Jinnah Sindh Medical University
Karachi01-2001
Skills
- Clinical Trial Protocols
- Clinical Research Design
- Medical Monitoring Plans
- Regulatory Requirements
- ICH Guidelines
- GCP Guidelines
- Scientific Integrity
- Problem-Solving Skills
- Leadership Experience
- Mentoring Skills
- Informed consent process
- Adverse event reporting
- Clinical study reports
- Investigator relations
- Site selection
- Data management
- Protocol development
- Medical writing
- Clinical research design
- Patient safety monitoring
Certification
- Lean Six Sigma (Yellow & Green Belt)
- OSHA Certified
- Bloodborne Pathogens Certification
- Clinical Development and Operations – Coursera
- CNPR – National Association of Pharmaceutical Sales Representatives
LANGUAGES
English
Arabic
Hindi
Urdu
Timeline
Cell Processing Specialist
CAR-T, Novartis
02.2025 - Current
Clinical Scientist
Alpha Clinical Development
09.2023 - 02.2025
Revenue Cycle Analyst
Phoenix Health Management
09.2021 - 09.2023
Shift Supervisor (Part-Time)
CVS Health
04.2021 - 09.2023
Clinical Program Coordinator
Altus Hospital
05.2018 - 04.2019
Product Specialist
Roche Pharmaceuticals
01.2015 - 01.2016
Product Specialist
3M Health Care
01.2013 - 01.2015
Product Manager – International Marketing
Organon Bio Sciences
09.2011 - 06.2012
Regional Sales Manager
Hilton Pharma
06.2010 - 09.2011
Professional Sales Representative
Merck Sharp & Dohme
02.2004 - 01.2009
Clinical Research Physician
Jinnah Postgraduate Medical Centre
09.2001 - 02.2004
Postgraduate Diploma - Clinical Research & GCP
James Lind Institute
Diploma - Sales & Marketing
Skill Development Council of Pakistan
MD (Doctor of Medicine) - undefined
Jinnah Sindh Medical University
Master of Science - EP, Heart & Pacemaker
University of Texas McGovern Medical School