About · OncAdios LLC

Jesús Gómez-Navarro, M.D.

A senior oncology drug development consultant and board-certified medical oncologist with 30+ years turning oncology science into development programs the FDA, EMA, PMDA, and NMPA have approved — now the independent advisory practice behind OncAdios.

Jesús Gómez-Navarro, M.D. — senior oncology drug development consultant
Currently advising a Series A oncology company through pre-IND endpoint selection and trial design

Jesús Gómez-Navarro is a board-certified medical oncologist with more than three decades in oncology drug development. As VP, Head of Clinical R&D at Takeda Oncology (2011–2020) and Takeda's inaugural Distinguished R&D Fellow (2020–2022), his strategic and technical leadership contributed to advancing the anti-CTLA-4 antibody tremelimumab from first-in-human through Phase 3, and to seven anticancer approvals across FDA, EMA, PMDA, and NMPA. Earlier in his career he held oncology drug-development roles at Pfizer and at Millennium Pharmaceuticals in Cambridge, Massachusetts.

He founded OncAdios LLC in 2022 to bring that judgment to AI-oncology and biotech companies as a fractional CMO, board director, or co-founder — the seat that carries a program through its endpoint, indication, trial-design, and FDA decisions. He is its sole principal; the practice has no partners, associates, or other named principals. Based in Madrid; much of the career above was built in the Boston and Cambridge oncology cluster, and he travels there when an engagement warrants it.

Career

Three decades in oncology drug development, then an independent practice.

Early career

Pfizer

Oncology drug development

Mid career

Millennium Pharmaceuticals

Oncology drug development
Cambridge, MA

2011 – 2022

Takeda Oncology

VP, Head of Clinical R&D (2011–2020)
Distinguished R&D Fellow (2020–2022)
Cambridge, MA

2022 – present

OncAdios LLC

Founder · Fractional CMO · Board director · Co-founder

Approvals contributed to across the career arc

NINLARO · ADCETRIS · ALUNBRIG · ICLUSIG · ZEJULA · CABOMETYX · EXKIVITY · and tremelimumab (later approved as IMJUDO) advanced from first-in-human through Phase 3.

What He Advises On

The decisions that determine whether an oncology molecule reaches the next phase.

  • Endpoint and indication strategy the FDA can actually review — translating AI-discovered targets and prioritized candidates into endpoint structures, trial designs, and pre-IND positions the agency has precedent to accept, and knowing when the science warrants a reasoned departure the evidence can defend.
  • Trial designs that enroll — pressure-testing inclusion/exclusion logic, referral patterns, line-of-therapy windows, and combination practicality against what community oncologists will actually prescribe, before the protocol is locked.
  • Regulatory translation — putting the science into the language and documentation tier a CDER review division will accept.
  • Independent adjudication for boards and investors — an independent read on whether a third party's oncology development story is calibrated, before a round, a partnership, or a disciplined no.

The engagement shapes range from a fixed-scope Calibration Sprint through a fractional CMO role, a board or scientific-advisor seat, or — rarely — a co-founder seat. The through-line is a single senior operator who stays accountable for the decision. How the consulting works →

Scientific & Professional Record

The verifiable record.

OncAdios is a public credibility and verification surface. The identity and scientific record above can be verified directly at the independent sources below — the authoritative places to find the peer-reviewed publication and presentation history.

Board-certified medical oncologist · 30+ years in oncology drug development · Contributions across FDA, EMA, PMDA, and NMPA approvals.

Start a Conversation

A small number of engagements per year.

If the decision in front of your program in the next 90 to 180 days is real and the program turns on it, the conversation is worth having. The fixed-scope Calibration Sprint is the front door.