Physician-Scientist | Clinical Development Executive | Regulatory Strategy Advisor
Kush Dhody, M.D., M.S.
Physician-scientist leading global clinical development and multi-regional regulatory strategy, with a focus on AI-enabled innovation in clinical research.
President, Amarex Clinical Research, LLC (An NSF Company)
Two Decades of Clinical Research Leadership
Dr. Kush Dhody is a physician–scientist and clinical research executive with more than two decades of experience leading global clinical development programs and regulatory strategy across the life sciences industry.
He has led multidisciplinary teams through the full arc of clinical development — from early-phase studies through pivotal trials and regulatory approval, across diverse therapeutic areas and global regulatory environments.
Dr. Dhody’s leadership integrates scientific expertise, operational discipline, and regulatory insight to drive efficient development pathways and consistent clinical execution across complex global programs.
He is currently focused on advancing technology-enabled innovation in clinical research through the integration of artificial intelligence and data-driven analytics. Through a strategic initiative with NSF and Microsoft Azure, he is leading the development of AI-enabled approaches to enhance regulatory processes and modernize clinical research operations. This work has been featured as a Microsoft customer success story.
Guiding Principles
The principles that guide leadership decisions, from resource allocation and risk management to team development and regulatory strategy.
Strategic Thinking
Aligning clinical development with regulatory success. Every development pathway must anticipate regulatory expectations, operational feasibility, and the evolving scientific landscape. Aligning these elements early, informed by extensive experience across global regulatory environments, strengthens the probability of success while protecting development timelines.
Scientific Integrity
Evidence-driven development and ethical research. Scientific credibility is the cornerstone of effective drug development. Decisions are grounded in rigorous data, transparent methodology, and uncompromising ethical standards, ensuring that research outcomes are reliable, reproducible, and trusted.
Operational Excellence
Execution discipline across global clinical programs. Even the strongest strategy requires disciplined execution. Operational excellence comes from building scalable, globally integrated systems and empowering cross-functional teams to deliver high-quality clinical trials consistently across development phases.
Professional Journey
- Expanding strategic partnerships and therapeutic scope
- Advancing AI-enabled innovation through the NSF/Microsoft Azure initiative
- Led operational strategy for diverse development programs, strengthening trial governance and cross-functional collaboration
- Built and scaled high-performing teams delivering clinical execution within a growing therapeutic portfolio
- Managed global clinical trials and built scalable operational infrastructure
- Strengthened clinical development capabilities across sponsor programs
Teaching & Curriculum Development
- Led instruction across drug development, regulatory strategy, clinical trial design, and GCP, integrating real-world case studies and applied learning
- Established program structure including curriculum design, evaluation frameworks, and industry engagement with NIH, NCI, and FDA participants
Therapeutic Areas
Clinical development leadership across 70+ clinical trials spanning Phase I–IV studies, including drugs, biologics, and medical devices. Programs have supported regulatory engagement with FDA, EMA, PMDA, Health Canada, and other international authorities across multiple therapeutic areas.
Core Leadership Competencies
The operational and strategic disciplines that drive consistent clinical program delivery across global regulatory environments.
Clinical Operations Management
Directing complex clinical trials from protocol design through regulatory submission, ensuring compliance with GCP and international standards.
Protocol Development & Governance
Design and implementation of clinical study protocols with focus on scientific rigor, patient safety, and regulatory alignment.
Regulatory Strategy & Compliance
Navigation of FDA and international regulatory frameworks, including IND submissions, audit preparation, and regulatory correspondence.
Team Building & Operational Excellence
Development of high-performing clinical operations teams with emphasis on accountability, data quality, and continuous improvement.
Strategic Partnerships
Identification and execution of collaborations that advance clinical research efficiency and operational capabilities.
Risk Management & Quality Assurance
Implementation of risk-based monitoring approaches and quality systems that ensure data integrity and patient protection.
Advisory Services
Strategic advisory for pharmaceutical and biotechnology startups, medical device innovators, investors, and academic research groups advancing therapies from scientific discovery through clinical development and regulatory approval.
Regulatory Strategy
Expert regulatory guidance to support efficient development pathways and effective engagement with global regulatory authorities.
- IND/IDE strategy, development planning, and submission readiness
- FDA meeting preparation and approval strategy
- Global development and approval pathway planning across major regulatory agencies
- Risk assessment and mitigation planning
Clinical Development
Clinical development strategies designed to maximize trial efficiency, regulatory alignment, and successful execution.
- Phase I–III clinical trial design aligned with regulatory expectations
- Site network strategy and patient enrollment optimization
- CRO selection, oversight, and governance
- Global clinical trials execution
- Practical application of AI to improve efficiency and consistency in clinical development and regulatory workflows
Biotech & Medtech Growth
Strategic advisory for emerging life-science companies advancing innovative therapies and technologies.
- Product development strategy from discovery through commercialization
- Clinical and strategic positioning for investor readiness
- Risk-based quality and operational frameworks
- Strategic partnerships and development collaborations
Accelerating
AI Innovation
in Clinical Research
A landmark collaboration with NSF and Microsoft Azure. By leveraging advanced AI tools, we are drastically reducing audit turnaround times, transforming weeks into days and enabling faster patient access to critical therapies.
“We're using AI to transform how we conduct regulatory audits, reducing review cycles from weeks to days while maintaining the highest quality standards.”
In the News
Coverage from industry publications and technology partners highlighting clinical development milestones, partnerships, and innovation.
NSF International Accelerates Clinical Audits with Azure OpenAI
“We're using AI to transform how we conduct regulatory audits, reducing review cycles from weeks to days while maintaining the highest quality standards.”
December 2025“Introducing AI has not only helped us reduce inefficiencies but also minimize the risk of human error when manually working with thousands of documents.” — Kush Dhody, President, Amarex Clinical Research
$1M MSCRF Grant Powers Novel Adipose Tissue Allograft Therapy
Amarex partners with Britecyte and ROSM on a clinical study for a novel osteoarthritis treatment, funded by the Maryland Stem Cell Research Fund.
November 2025“We are proud to be the partner of choice for Britecyte and ROSM, supporting the clinical study funded by the MSCRF grant. Bringing innovative therapies to market is part of our DNA at Amarex.” — Kush Dhody, President, Amarex Clinical Research
Britecyte's Adipose Tissue Allograft Earns 'Safe to Proceed' from FDA
Amarex Clinical Research handled the IND application as clinical research partner, securing FDA authorization to proceed with the clinical trial.
February 2025“For millions of people trapped in debilitating pain, this news is a welcome relief. We were proud to handle the Investigational New Drug (IND) application for Britecyte and honored to act as their clinical research partner as they bring this life-enhancing product to market.” — Kush Dhody, President, Amarex Clinical Research
Selected Publications & Research
Peer-reviewed publications, white papers, and research contributions across oncology, infectious disease, and immunology.
Implementing ICH M11: A CRO Leadership Perspective on Protocol Standardization and AI Integration
White Paper
AI-Enabled Clinical Research Operations: From Concept to Implementation
White Paper
The Evolving CRO-Sponsor Partnership Model: Strategic Value Beyond Outsourcing
White Paper
Risk-Based Quality Management in a Post-Pandemic CRO Environment
White Paper
Conference Presentations
Invited and selected speaker at leading global scientific and clinical conferences.
Phase Ib/II Study in CCR5+ mTNBC Patients
Oral abstract presented at AACR Annual Meeting — Philadelphia, PA. Cancer Res 2020;80(16 Suppl): Abstract nr CT233.
A Phase 2 Study for Mild to Moderate Coronavirus Disease 2019 (COVID-19)
Abstract selected for oral presentation at isirv-AVG Special Virtual Conference “Therapeutics for COVID-19” — Virtual, Oct 6–8, 2020.
Final Results of the Pivotal Study in Heavily Treatment-Experienced HIV Patients
Oral abstract and poster presented at ASM/ICAAC — San Francisco, CA, Jun 20–24, 2019.
A Long-Acting, Single-Agent Maintenance Therapy (SAMT) for HIV-1 Infection
Abstract selected for poster presentation at CROI — Seattle, WA, Mar 4–7, 2019.
What Colleagues Say
Beyond the Boardroom
Golf & Strategic Mindset
Golf reflects the principles of clinical development leadership: patience, long-term vision, and disciplined execution. It reinforces the importance of thoughtful decision-making, adaptability, and composure under pressure.
Mentorship
Committed to developing the next generation of clinical research leaders, grounded in a long-standing engagement in academic teaching and a belief that leadership is ultimately measured by what you build in others.
Get in Touch
For speaking engagements, partnership opportunities, advisory inquiries, or media requests.
Response Time
Typically within 2-3 business days for professional inquiries