Dr. Mukesh Ahuja

Dr. Mukesh Ahuja is a global Clinical and Medical Affairs leader with more than 20 years of experience driving clinical strategy, clinical operations, medical affairs, and evidence generation across biologics, pharmaceuticals, and medical devices. His expertise spans the full clinical development lifecycle, from study start-up and early-phase development through regulatory submissions, pivotal trials, post-market studies, and real-world evidence generation.

Dr. Ahuja has led global Phase I–IV clinical development programs and supported IND, IDE, BLA, CTA, and CTN regulatory submissions across North America, Europe, Asia-Pacific, and other international markets. His therapeutic expertise includes orthopedics, spine, musculoskeletal disorders, osteoarthritis, regenerative medicine, hematology, and rare diseases, with additional cross-therapeutic experience in endocrinology, ophthalmology, immunology, inflammation, and pain.

Throughout his career, Dr. Ahuja has built and scaled clinical organizations, establishing clinical operations, medical affairs, pharmacovigilance, safety, risk-management, and evidence-generation frameworks. He has led multidisciplinary teams, managed CROs and global vendors, and aligned clinical and regulatory strategies with market access, commercial, academic, and investor objectives.

As Global Clinical Head of Osteoarthritis at Paradigm Biopharmaceuticals, Dr. Ahuja led global clinical development programs exceeding $300 million across more than 120 sites in the United States, Australia, Europe, the United Kingdom, Canada, and Brazil. He directed Clinical Affairs, Clinical Operations, Clinical Trial Liaison, and Project Management functions; led adaptive Phase IIb/IIIa and pivotal Phase III programs involving more than 990 participants; and achieved key regulatory milestones, including IND, CTA, and CTN clearances and FDA Fast Track designation. He also oversaw global vendors and implemented strategic governance and risk-management initiatives that generated more than $20 million in cost savings.

Previously, as Vice President of Clinical & Medical Affairs at Ortho RTI, Dr. Ahuja led the clinical and medical strategy for a first-in-human Phase I/II soft-tissue repair and regeneration drug-biologic combination program, achieving IND clearance. His responsibilities included clinical strategy, protocol development, CRO and vendor oversight, biomarker and imaging programs, safety governance, regulatory interactions, and the development of foundational clinical operations infrastructure.

His broader industry experience includes clinical affairs and program leadership in motion preservation and cervical disc arthroplasty, including clinical evidence planning, site and study design, regulatory strategy, systematic reviews, implant retrieval programs, and surgeon and KOL engagement.

Dr. Ahuja also serves as a Medical Advisory Board Member at Cytonics Corporation, providing strategic and scientific guidance across clinical research, regulatory planning, translational research, business development, and partnership development. In addition, he has served as a consultant supporting industry-sponsored research programs at Rush University Medical Center.

Known for connecting scientific and clinical development with business objectives, Dr. Ahuja works with startups, emerging and established biotechnology companies, global healthcare organizations, and academic institutions to advance clinical programs, manage risk and cost, strengthen evidence strategies, and translate scientific innovation into sustainable market value.

His core areas of expertise include global clinical strategy and trial leadership, regulatory submissions, medical affairs, pharmacovigilance, real-world evidence and post-market clinical follow-up, KOL engagement, CRO and vendor oversight, clinical risk management, financial governance, and strategic partnerships.