Senior Medical Director, GI Oncology & Biosimilars Program Lead at Shanghai Henlius Biotech, Inc. (2025-08 – Present)
Lead the GI oncology and biosimilars division with six direct reports. Scope covers late-stage immuno-oncology, HER2-targeted therapy, and a biosimilar portfolio of eleven molecules at varying stages of development and commercialization in the United States, the European Union, and Asia-Pacific.
- Medical Monitor and Clinical Lead for three active trials: HLX43-NSCLC201 (NSCLC), HLX10-005-SCLC301-E (extensive-stage SCLC, serplulimab-based regimen, BLA in preparation), and HLX22-GC-301 (gastric cancer, HER2-targeted). Full sponsor-level responsibility for safety surveillance, protocol deviation management, and the sponsor interface with the independent data monitoring committee.
- Biosimilar portfolio includes HLX01 (rituximab), HLX02 (trastuzumab / HERCESSI™ / Zercepac®), HLX04 (bevacizumab), HLX11 (pertuzumab / POHERDY®), HLX14 (denosumab / Bildyos®), HLX17 (pembrolizumab), and five additional molecules across oncology and supportive care.
- Built the medical monitoring training curriculum for the GI team, on the basis that the quality of monitoring decisions determines both patient safety and data integrity.
Founder at OCREA (Oncology Clinical Research Excellence Academy), Nieto Hernandez Investments LLC (2024-02 – Present)
- Built a 61-module curriculum across ten tracks for oncology Medical Monitors, Clinical Scientists, and Clinical Science Liaisons, organized by the operational sequence of the role, with a nine-tool kit mapped to the Medical Monitor workflow.
- Authored the Oncology Medical Monitor and Clinical Scientist Handbook, covering protocol review, data monitoring, safety signal detection, and result interpretation across all trial phases.
- Publishes a recurring LinkedIn series on oncology clinical development practice for an audience of Medical Monitors, Clinical Scientists, and foreign medical graduates entering the field.
Independent Senior Research Physician at Independent Contractor / Consultant (2024-06 – 2025-08)
- Advised multiple sponsors on oncology drug development strategy: study design, safety surveillance frameworks, benefit-risk assessment, and IND/BLA preparation, across immuno-oncology, targeted therapy, and biosimilar programs in United States, European Union, and Asia-Pacific regulatory environments.
- Ran external scientific advisory boards and steering committees, aligning development decisions with KOL input and evolving FDA and EMA expectations.
- Evaluated drug assets for business development purposes: endpoint viability, safety signal risk, competitive positioning, and development pathway.
Senior Medical Director / Global Clinical Lead at Pfizer Inc. (2007-12 – 2024-02)
Senior Medical Director – GB TA Clinician (January 2019 – February 2024) and Senior Medical Director / Medical Director – Global Clinical Lead (March 2009 – January 2019) and Medical Director, Clinician Oncology – RCC & Solid Tumors (December 2007 – March 2009).
- Clinical Lead and Medical Monitor for Besponsa (inotuzumab ozogamicin, ADC/ALL) and lorlatinib (ALK/ROS1 TKI, NSCLC) through Phase 2–4, including NDA/BLA/MAA submissions, post-marketing studies, and IDMC oversight from the sponsor side.
- For Besponsa: primary medical responsibility for veno-occlusive disease and hepatotoxicity surveillance, benefit-risk documentation, and REMS strategy. For lorlatinib: CNS toxicity monitoring, hypercholesterolemia and lipid management protocols, and RECIST-based response tracking through approval.
- Prepared and negotiated NDA, BLA, and MAA submissions supporting multiple oncology approvals. Conducted Type B and Type C meetings with FDA and EMA and participated in label negotiations in the United States, the European Union, and Japan. Authored the clinical sections of those packages.
- Led cumulative safety reviews with the Safety Risk Lead, authored PSUR/PBRER content, and delivered post-marketing commitments on schedule.
- Medical leadership from proof of concept through late phase across solid tumors and hematologic malignancies. Defined endpoint strategy, RECIST/iRECIST criteria, and scientific rationale for multiple programs.
- Managed a team of eight in global trial execution: site selection, KOL and investigator qualification, and patient population strategy across the United States, Europe, Latin America, and Asia-Pacific. Implemented biomarker-enriched enrollment and adaptive design elements where feasible.
- Owned the sponsor interface with independent data monitoring committees and endpoint adjudication committees: briefing book preparation, interim analysis governance, protocol integrity oversight, and implementation of committee recommendations.
- Coordinated five medical and clinical sub-teams across regulatory, biostatistics, pharmacovigilance, and clinical operations. Wrote the integrated safety and efficacy narratives for clinical study reports, IDMC briefing books, regulatory packages, and peer-reviewed manuscripts.
- Built the oncology medical monitor training curriculum used by the group.
- Medical Monitor of record on the global sunitinib expanded-access trial (51 countries, N > 4,000) and the renal cell carcinoma brain metastases cohort study. Results published in The Lancet Oncology (2009) and Cancer (2011); both studies generated data that informed the sunitinib label in RCC.
Research Consultant – Oncology and Rare Diseases at Various Sponsors (1995-01 – 2007-12)
Sponsor-level consultancy across oncology and rare disease programs: protocol development, safety monitoring, and regulatory strategy in early- and late-phase studies.
