Jie Shen

25 years of experience in the pharma/device industry, with increasing responsibility leading teams of technical and managerial staff to guide nonclinical and clinical development activities. Global project team leader directing preclinical to Ph2/3 clinical programs (ophthalmology, medical dermatology/aesthetics), responsible for strategy, timeline, budget, and communication with governing bodies, KOLs, as well as global health agencies for clinical development plans and study designs. Highlighted experience: - Organizational leadership/talent development - Drug development and regulatory interactions, with strategic positioning of nonclinical (PK+PD+Tox), CMC, and clinical pharmacology data - Post approval marketing support and KOL engagement - Advisory board engagement - Due diligence for in-licensing opportunities with a focus on ophthalmology and dermatology/aesthetic assets Expertise: - Bioanalysis/Biomarker/PK/Clin Pharm/Immunogenicity/Immunosafety, including Ph1/2a FIH study design and conduct for neurotoxin, aesthetic and ophthalmology assets - Drug delivery (sustained delivery including cell/gene therapy for ophthalmic indications/novel delivery platform for skin and muscle) - Ophthalmology, Dermatology, Aesthetics, Neurology - Nonclinical and clinical drug development - Partnership and governance in co-development programs with biotech startups