Giuseppe Russo

About Giuseppe Russo

Executive Director–level Clinical Science & Clinical Development leader with 30+ years of combined experience in cancer research in academia, clinical science and oncology drug development across global pharma and public biotech in the US and Europe. I build and lead Clinical Science functions, establish fit-for-purpose governance, and drive scientific execution across Phase programs in solid tumors and hematologic malignancies.My expertise spans ADCs, bispecific antibodies, and immuno-oncology, with hands-on ownership of protocol strategy, medical monitoring, safety oversight, and regulatory documentation supporting IND and BLA submissions. I have supported interactions with the FDA and European Health Authorities, including the EMA, and contributed to the FDA approval of KEYTRUDA for Merkel cell carcinoma at Merck.In biotech settings, I have built Clinical Science infrastructure from the ground up—leading multi-program portfolios, hiring and mentoring teams (3–5 direct and dotted-line reports), defining decision rights, and partnering closely with Clinical Development, Regulatory, Safety, Biometrics, and Translational functions to advance programs efficiently through key regulatory milestones.My leadership style is pragmatic and people-focused: clear standards, direct communication, and accountable, data-driven decision-making, always centered on patients.Focus: Clinical Science and clinical development leadership • Oncology development (Phase • FDA/EMA interactions • IND/BLA strategy • Medical monitoring • Team building • Project Management • Clinical Operations

Experience

1. Executive Director, Integrated Clinical Development Cells Lead

   SystImmune

   Mar 2026 — Present · Princeton, NJ, US

   Serve as the single point of accountability for the entire development program, owning everything from early strategy through execution- setting and driving the asset development strategy, providing clinical and scientific oversight across all program clinical trials (including protocol development, study oversight, and data review)- leading cross-functional project management- shaping the competitive landscape assessment

Education

• Università degli Studi di Napoli Federico II

  B.S, M.S, Biology summa cum laude

  1988 — 1997

• Università di Siena

  PhD, Pathology

  2001 — 2005