Qi Dong, MD, MPH, MBA

Medial Director/Senior Medical Director, Clincial Science - Oncology @ Takeda

About

Clinical development leader in oncology with experience across early- and late-stage programs. Currently serving as Global Clinical Lead for pancreatic cancer development, focused on translating scientific rationale into pragmatic, patient-centered clinical strategies. Experienced in first-in-human, proof-of-concept, and registrational studies, including biomarker-driven and combination approaches. Brings extensive global experience, with deep and hands-on engagement across Asia, and works closely with cross-functional teams across Clinical Operations, Translational Medicine, Regulatory, Biostatistics, and Commercial, as well as external partners, to support development strategy, governance discussions, and selected external collaboration activities. Motivated by advancing innovative therapies for patients with high unmet medical need.

Country

City

United States

Industry

Pharmaceuticals

Skill

Clinical Development, Pharmaceutical Industry, Clinical Trials, Biotechnology, Life Sciences, Oncology, CRO, Regulatory Submissions, Clinical Research, Regulatory Affairs, GCP, MBA

Experience

Medial Director/Senior Medical Director, Clincial Science - Oncology

Takeda

2021-7 - Present · 5 yrs 3 mos

Cambridge, MA

Serve as Global Clinical Lead for pancreatic cancer development, with end-to-end responsibility for clinical strategy and execution across early- and late-stage oncology programs. Lead development planning for first-in-human, proof-of-concept, and registrational studies, including biomarker-driven and combination approaches. Drive cross-functional alignment across Clinical Operations, Translational Medicine, Regulatory, Biostatistics, Safety, and Commercial to support high quality trial execution and data driven decision making. Actively contribute to governance discussions, lifecycle planning, and selected external evaluation and collaboration activities to advance innovative oncology assets.

Associate Medical Director / Medical Director, Oncology Clinical Development

Takeda

2018-11 - 2021-7 · 2 yrs 9 mos

Shanghai, China

Led oncology clinical development activities for China within global programs, with a focus on adapting global trial strategies to regional regulatory and clinical requirements. Played a key role in achieving two landmark NDA approvals in China, including development of companion diagnostics and support of the first Breakthrough Therapy Designation granted in China. Acted as a strategic bridge between global teams and local stakeholders, aligning global development goals with regional execution.

Senior Director, Clinical Development and Portfolio Management

Ascentage Pharma

2017-5 - 2018-11 · 1 yr 7 mos

Shanghai, China

Provided clinical leadership for early-stage oncology programs across a small-molecule portfolio. Served as clinical lead for multiple Phase 1 studies conducted in China and Australia, including first-in-human development. Led IND clearance with the US FDA and execution of early clinical studies, while supporting academic collaborations and external partnerships to advance portfolio and development strategy.

Assistant Director, Asia Pacific Project Lead & Clinical Lead

Sanofi

2015-3 - 2017-5 · 2 yrs 3 mos

Shanghai, China

Led clinical development programs across cardiovascular and immunology portfolios in the Asia Pacific region. Managed IND and NDA submissions across multiple Asian markets and strengthened cross-functional execution through improved project governance and operational frameworks. Played a key role in aligning regional development activities with global strategy.

Operation Manager & Sr. Clinical Research Manager

Sanofi

2011-10 - 2015-3 · 3 yrs 6 mos

Beijing, China

Study Manager

Bayer

2009-12 - 2011-10 · 1 yr 11 mos

Beijing, China

Education

Harvard T.H. Chan School of Public Health

Epidemiology

2022 - 2024 · 2 yrs

Focused on epidemiologic methods, biostatistics, and real-world evidence to support data-driven clinical development and public health decision making.