Clinical Development Strategy
Development plans, study concepts, endpoints, dose/exposure or performance questions, stopping criteria and practical risk-mitigation approaches.
Clinical Development & Translational Safety
Chirag Dhar,MBBS, MAS, DPM, FAPCR
Physician-scientist advising organizations across biopharma, medtech and diagnostics on clinical development, translational safety, medical monitoring and evidence strategy.
Clinical development strategy grounded in translational science, medical judgment and disciplined evidence interpretation.
Nonclinical
Translational
Clinical
Decision
Evidence, connected with intent.
About
Medicine, science and clinical development.
Chirag Dhar, MBBS, MAS, DPM, FAPCR, is a physician-scientist and clinical development consultant whose work brings together medical training, clinical research, translational science and industry clinical development.
Across academic and industry settings, he has worked with biological rationale, nonclinical pharmacology and toxicology, safety, efficacy, biomarkers and clinical data. His approach is evidence-first: clarify what the data support, identify uncertainty and frame the next development question.
Areas of work
Connecting evidence to practical development questions.
Focused support for teams navigating complex scientific, clinical and safety decisions.
Translational Safety
Connecting mechanism, pharmacology, toxicology, biodistribution, product performance, organ-system risk and disease biology to anticipate clinical safety questions.
Medical Monitoring and Clinical Safety
Interpreting safety, efficacy, performance, biomarker, eligibility and protocol-deviation data to support clear, timely study decisions.
Regulatory and Scientific Evidence
Building coherent evidence narratives across plans, protocols, intended-use questions, investigator materials, clinical summaries and briefing materials—without overstating what the data support.
Experience
Experience across the evidence continuum.
Work connecting translational evidence with clinical development and safety decisions.
His work spans clinical development and evidence strategy across vaccines, mRNA therapeutics, biologics, and cell and gene therapies, including AI/ML-driven biomarker development and the application of biomarkers for safety, efficacy, screening, and treatment response. His publicly disclosed industry affiliations have included PopVax, Biological E., Zumutor Biologics, and InterVenn Biosciences.
Organizations are identified for biographical context only. Their inclusion does not imply endorsement of independent consulting work.
Selected scholarship
Research across mechanistic, translational and clinical evidence.
Complete Scholar profile2026The Lancet Regional Health – Southeast AsiaImmunogenicity and safety of Biological E’s 14-valent pneumococcal conjugate vaccine (PNEUBEVAX 14®) administered in a 2p + 1 schedule to healthy infants2025The Lancet Regional Health – Southeast AsiaSafety and immunogenicity of booster doses of an XBB.1.5 RBD subunit COVID-19 vaccine among individuals aged 5–80 years in India2024British Journal of CancerDiagnosing and staging epithelial ovarian cancer by serum glycoproteomic profiling2021Proceedings of the National Academy of SciencesSialoglycan recognition is a common connection linking acidosis, zinc, and HMGB1 in sepsis2019Frontiers in ImmunologyFrom ‘Serum Sickness’ to ‘Xenosialitis’: Past, Present, and Future Significance of the Non-human Sialic Acid Neu5Gc
Beyond Work
Away from the desk, Chirag plays squash and pickleball, swims the open-water route between La Jolla Cove and the Marine Room, and dives off Neil and Havelock Islands. He also lends a hand restoring a friend’s 1959 Austin-Healey 100-6.
Get in touch
Discuss a clinical development question.
For consulting, advisory or scientific collaboration discussions across biopharma, medtech and diagnostics, please get in touch by email or LinkedIn.