Bijan Nejadnik

Orca Bio, a late-stage biotechnology company focused on advancing high-precision cell therapies, has appointed Bijan Nejadnik, M.D., as Chief Medical Officer (CMO). 

The appointment reinforces the company’s leadership team as it continues to advance its clinical pipeline and development programs.

As part of the leadership transition, J. Scott McClellan, M.D., Ph.D., will move from his position as Chief Medical Officer to the newly created role of Chief Development Officer. In this capacity, he will lead the expansion of Orca Bio’s pipeline and oversee the progression of next-generation therapeutic programs into clinical development.

Dr. Nejadnik brings more than two decades of experience in global medical, clinical, and regulatory strategy. He joins Orca Bio from Tanabe Pharma, where he served as Chief Medical Officer and Head of Research & Development and Regulatory Affairs. Throughout his career, he has led multidisciplinary teams responsible for advancing biologics from early-stage development through regulatory approval and commercialization.

His experience includes overseeing regulatory submissions and approvals with major health authorities, including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). He has also played a significant role in guiding clinical programs across oncology, immunotherapy, and cell-based therapies.

In addition to his clinical and regulatory expertise, Dr. Nejadnik has served on the boards and executive leadership teams of several biotechnology companies, contributing to corporate strategy, fundraising initiatives, and merger and acquisition activities. Earlier in his career, he held academic appointments at Johns Hopkins University, Cornell University, and Stanford University.

Dr. Nejadnik earned his medical degree with honors from the Catholic University of Louvain in Belgium. As Chief Medical Officer, he will help drive Orca Bio’s clinical and regulatory strategy while supporting the continued development of the company’s cell therapy portfolio.