Dylan Lee, MD, PhD, MBA, FRSM

Founder & CMO

About

A global Chief Medical Officer and biotech executive with over 25 years of leadership across oncology, immunology, inflammation, gene therapy, anti-infectives. Combines deep clinical and scientific expertise with strategic business acumen, having led end-to-end clinical development, global operations, medical affairs, and corporate strategy in both early-stage ventures and multinational biopharma. Successfully directed 20+ IND submissions (FDA, EMA, NMPA) and achieved positive clinical outcomes leading to NDA filings in both the U.S. and China. Experienced in cross-border leadership roles spanning the United States, China, Europe, and the UK. Raised venture capital and led major M&A transactions. Proven ability to scale organizations from inception to global execution, managing cross-functional teams of 120+ across regions. Equally effective in hands-on clinical execution and strategic investor engagement. Served as Professor and Principal Investigator at leading institutions in both the U.S. and China.

Country

City

United States

Industry

Pharmaceuticals

Skill

Medical Affairs, principal investigator, Teaching, Molecular Medicine, Oncology, Academic Research, clinical reasearch, Patient Care, Regulatory Guidelines, Decision-Making, Resource Allocation, Budget Management, Site Selections, Stakeholder Engagement, Research Projects, Oncology Clinical Research, Organization Skills, Drug Development, Good Clinical Practice (GCP), Clinical Study Design

Experience

Founder & CMO

CuraStrategix

2025-1 - Present · 1 yr 9 mos

Founded and lead a U.S.-based S-corporation consulting firm specializing in clinical development strategy, regulatory submissions (FDA, NMPA, EMA), scientific communications, and global medical affairs. Provide high-impact advisory services across biotech and pharmaceutical sectors, guiding innovative products from early-phase development through global filings. Engage directly in trial design, regulatory engagement, and commercialization planning across immunology, oncology, and neuroinflammation.

Chief Medical Officer, Senior Vice President, Head of Corporate Development

百明信康生物技术（杭州）有限公司 Worgpharma

2023-1 - 2025-1 · 2 yrs 1 mo

Global

Led global medical strategy, clinical development, and business development activities. Oversaw clinical operations, IND/NDA preparation, strategic M&A, and investor relations. Drove Phase 1–3 trial design and execution in autoimmunity, transplant, and infectious diseases. Successfully managed cross-border licensing, corporate partnerships, and due diligence processes.

Head of Medicine, Chief Medical

Sinovent Pharma

2021 - 2023 · 2 yrs

Global

Directed all clinical development and regulatory activities across multiple immune, inflammatory, and oncology programs. Oversaw full trial lifecycle from protocol design to post-study analysis. Managed cross-functional medical teams and ensured alignment with global regulatory agencies (FDA, EMA, CDE).

Executive Medical, US Chief Medical

AnHeart Therapeutics

2019 - 2022 · 3 yrs

Served as U.S. clinical lead for biomarker-driven oncology assets, including three global Phase 2 and two Phase 1 trials. Directed IND submissions, FDA/CDE interaction, protocol design, CRO oversight, and medical writing. Led regulatory strategy and clinical development budgets.

Clinical Program Lead

Pharmaron

2018 - 2022 · 4 yrs

Oversaw global clinical programs (Phases I–IV) across solid tumor, hematology, and immunology indications. Directed regulatory submission strategies, team management, and GCP compliance. Built cross-border clinical SOPs and coordinated regulatory/medical/scientific teams.

Professor in Molecular Medicine

Case Western Reserve University School of Medicine

2016-1 - 2020-12 · 5 yrs

Delivered advanced molecular medicine curriculum. Served on the School of Medicine Admissions Committee.

Physician-Scientist, Research Leader

Cleveland Clinic

2010-3 - 2020-12 · 10 yrs 10 mos

Patient care, Built national biobank, regenerative medicine program, and translational programs. Led translational research in immunology and oncology. Directed multiple Phase I–III clinical trials on principal investigator role. Led clinical and translational research in immunoregulation. Directed multiple collaborative studies and scientific publications. Provided medical insight to early- to late-phase drug programs.

Interventional Cardiologist

NO 1 Hospital of Lanzhou University

2005-7 - 2010-4 · 4 yrs 10 mos

Worked as a stent implantation physician in the Catheterization Surgery Center and Intensive Care Unit at No.1 Hospital of Lanzhou University in China.