Gordon I.

About Gordon I.

I am an accomplished Senior Medical Executive with experience spanning clinical development, medical affairs, and academia, with deep expertise in immunology, organ transplantation, and liver disease. My work has focused primarily on Phase 2 and Phase 3 global programs, leading complex development efforts in high-unmet-need indications from strategy through execution.My foundation includes hands-on patient care, authorship of investigator-initiated clinical research, peer-reviewed publications and abstracts, national and international scientific presentations, and precepting students and residents. This clinical and academic grounding continues to inform my approach to drug development and medical leadership.Known for strategic vision and cross-functional leadership, I translate complex clinical and scientific data into clear development strategy and decisive action. My experience spans portfolio evaluation, regulatory strategy, clinical development and medical affairs leadership, and mentoring high-performing multidisciplinary teams. I also actively apply my development expertise to angel investing and biotech opportunity assessment, with growing involvement in search, evaluation, and diligence of emerging life science companies.Throughout my career, I am proud to have- Designed and executed a global Phase 3 clinical development program in antibody-mediated rejection (AMR) in kidney transplantation, advancing from concept to first patient enrolled in nine months- Successfully integrated and scaled a novel transplant program post-acquisition within a large pharmaceutical organization, aligning cross-functional teams and accelerating execution- Led regulatory strategy and high-stakes interactions with the FDA and global health authorities, shaping clinical and scientific narratives for complex indications- Built and mentored high-performing clinical development teams across Clinical Operations, Biometrics, Translational Medicine, and Medical Affairs, earning credibility with investigators and internal stakeholders- Applied clinical development expertise to angel investing and portfolio evaluation, assessing scientific risk, clinical differentiation, and strategic fit for emerging biotech companies.Outside of work, I am passionate about travel, food, and staying active. Having explored over 70 countries, I value the cultural perspective and adaptability that global experiences bring to both leadership and innovation.

Experience

1. Senior Medical Director, Global Clinical Development Program Lead

   Hi-Bio A Biogen Company

   Feb 2024 — Present

   Lead clinical development strategy and execution for the transplantation portfolio, providing medical expertise across all phases of clinical programs and guiding cross-functional teams from proof-of-concept through Phase 3. Serve as a subject matter expert, representing the company to regulatory authorities, investigators, and KOLs, while integrating patient perspectives into clinical trial design and development planning- Chaired the transplant clinical development governance body, overseeing 15–20 mid- to senior-level managers and ensuring alignment on asset strategy, regulatory planning, and development milestones- Designed and executed comprehensive clinical development plans, regulatory strategies, and clinical trials adhering to ethical and regulatory standards- Authored and reviewed critical clinical and regulatory documents, including protocols, IBs, ICFs, CSRs, CRFs, DSURs, abstracts, posters, and manuscripts- Built, mentored, and led a high-performing team of medical directors, clinical scientists, and consultants, shaping clinical development strategies and advancing pipeline programs- Advanced patient-centric initiatives, incorporating patient feedback into trial design and product lifecycle strategies- Monitored competitive intelligence and emerging data to inform program decisions and enhance scientific credibility externally.

Education

• The University of North Carolina at Chapel Hill

  Bachelor of Science, Pharmacy

• The University of North Carolina at Chapel Hill

  Doctor, Pharmacy