About Nathalie Riebel

Over 30 years in oncology clinical trials

I'm an independent, hands-on clinical operations leader who's run every kind of oncology trial — from first-in-human dose escalation through global phase 3, including investigator-initiated and master protocols. Founders bring me in when they have a promising asset and need an operator to take it into the clinic.

13+

years in Pharma

Eli Lilly • GSK

Ran clinical operations at two of the world's largest oncology companies, including a custom-built Head of Inspection Readiness role.

15+

years in CRO Leadership

IQVIA • ICON

Led project management, portfolio and program delivery, and full trial teams as a Director across large and mid-size CROs.

7+

years in Biotech Leadership

ImClone • Delcath • PDS Biotech

Built clinical operations from the ground up: the departments, standards, systems, and teams early-stage biotechs don't have yet.

Three decades across pharma, CRO, and biotech. Here's what it does for you.

Clinical trial consultant Nathalie Riebel of Oncospire presenting CRO oversight strategy to biotech leadership team

If you're a founder with a promising molecule in preclinical and no in-house clinical operations, this is where I come in. I help you design and operationalize your first-in-human trial and carry it from preclinical through IND filing to first patient dosed.

  • Protocol design

  • CRO selection and oversight

  • Phase 1 and phase 2 trial setup

  • Fit-for-purpose vendor oversight — right-sized to your trial, not a bloated system

I don't advise from the sidelines — I’m the operator, from IND filing to the first patient dose.

Tumor Types

  • Experience in:

    • Breast cancer

    • Ocular Melanoma

    • Cholangiocarcinoma

    • Colorectal

    • Small Cell Lung Cancer

    • Melanoma

    • Head and Neck Cancer

    • Pancreatic and Renal Cancer

    • Acute Myeloid Leukemia

    • Chronic Lymphocytic Leukemia

  • Infantile Hemangioma

Treatment Modalities

    • Monoclonal Antibodies

    • Immuno-modulator

    • Interferons

    • Interleukins

    • Immune Checkpoints

    • Oncolytics

  • T cell activating platforms

    • Tyrosine kinase

    • RAF

    • VEGF

Publications

  • ASCO 2023 Price KAR, Kaczmar JM, Worden FP, Wood LV, Schaaf DT, Riebel N, Chaney MF, Weiss J. Safety and efficacy of immune checkpoint inhibitor (ICI) naïve cohort from study of PDS0101 and pembrolizumab in HPV16-positive head and neck squamous cell carcinoma (HNSCC). Journal of Clinical Oncology 41, no. 16_suppl (June 01, 2023) 6012-6012. DOI: 10.1200/JCO.2023.41.16_suppl.6012 Published online May 31, 2023.

  • ASCO 2022 Weiss J, Chintakutlawar AV, Price KAR, Kaczmar JM, Riebel N, Bedu-Addo FK, Chaney MF, Wood LV. PDS0101, a novel type I interferon and CD8 T-cell activating immunotherapy, in combination with pembrolizumab I subjects with recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma. Journal of Clinical Oncology 40, no. 16_suppl (June 01, 2022) 6041-6041. DOI: 10.1200/JCO.2022.40.16_suppl.6041

  • ESMO TAT 2023 Wood L, McCarthy S, Schaaf D, Riebel N, Jones S, Cotty A, Bick J. HPV16-specific CD4 and CD8 T-cell activation and functionality in patients receiving combination PDS0101 immunotherapy. ESMO TAT 2023, Paris, France, March 6-8, 2023. Abstract 246.

  • ESMO 2023 Harrington K, Weiss J, Price K, Kaczmar J, Schaaf D, Riebel N, Jones S, Cotty A, McCarthy S, Wood L. Polyfunctional HPV16-specific T cell responses in subjects receiving PDS0101 and pembrolizumab combination treatment for recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC).  ESMO 2023, Madrid, Spain, October 20-24, 2023. Final Publication Number [FPN] 924P. (Note: the submitted assigned abstract # was 6982).

Built to withstand the inspection before it happens.

For [x] years I served as Head of Inspection Readiness for [company]'s oncology franchise — a role created specifically for me, building the program from the ground up. Inspection readiness isn't something you scramble for when the FDA calls; it's built into how a trial runs from day one. That's how I run yours — so when scrutiny comes, your trial is already prepared for it.

Clinical trial consultant Nathalie Riebel of Oncospire Consultants specializing in CRO selection and oversight systems

##+

people on the largest team led

$$$+

in clinical trial budgets overseen

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trials from setup to execution

You have a molecule in preclinical. Let's get it to first patient dose.

Working alongside your team, I design and operationalize your first-in-human study so it meets its milestones, withstands scrutiny, and stays on timeline.

Book Your Clinical Momentum Call