Clara Cambon Thiebaud

Fractional Regulatory Affairs Executive | Strategic Leader | Transforms Regulatory obstacles into opportunities | Thrives on complex drug development challenges | Board Director Nonprofit AIxBio 👉 BioLiterate

Role
Board Director - Clinical Development & Regulatory Strategy at Bioliterate
Location
Brooklyn, NY, US
LinkedIn followers
500 followers

About Clara Cambon Thiebaud

Hello/Bonjour! I serve as a Consultant and Fractional VP of Regulatory Affairs for biotech companies navigating complex global development programs, bringing both strategic leadership and deep scientific grounding as a trained Pharmacist. I help small- to mid-sized clinical-stage companies overcome Regulatory hurdles. I am based in NYC. Are you wondering how to craft a Global Regulatory strategy that can differentiate, accelerate, and de-risk your development program? Looking for an expert to pressure-test assumptions before your next investment? Curious about positioning an asset through an efficient Clinical Development Plan but unsure how to engage regulators to endorse your innovative trial designs?These are the complex challenges I focus on in my independent consulting practice. With experience spanning Pharma and biotech, from early clinical-stage rare diseases to marketed blockbusters, I help companies develop competitive products at every stage of development by working with the end in mind. I specialize in progressing therapeutics for serious conditions and/or rare diseases. I partner with high-performing, ambitious drug developers (small molecules and biologics) who want to lay out the steps for a successful Health Authority engagement strategy rooted in science. Your relationship with regulators is a tremendous asset. I can help you: design clinical trials that are cleared globally, collaborate with Health Authorities, and evaluate and manage regulatory risk. I also partner with VCs to evaluate risk and the probability of regulatory success for companies in their portfolio.Regulatory excellence is a cornerstone of biotech strategy and execution, and my clients who best understand this have found Pharma partners or been acquired, with combined exits exceeding $6 billion.I have also developed a robust network of experts and am happy to make introductions to help get your program to the next stage.I\'d welcome the chance to connect.

Experience

  1. Board Director - Clinical Development & Regulatory Strategy

    Bioliterate

    Jan 2026 — Present · New York, NY, US

    As a Regulatory Affairs and Drug Development leader, I joined a nonprofit cultivating AI literacy at the intersection of biopharma and healthcare.Our mission is to build a vibrant community of practice where biomedical professionals develop the skills to responsibly leverage AI for faster drug development, breakthrough treatments, and better patient outcomes.

Education

  • Paris-Sud University (Paris XI)

    Master's of Science, International Drug Development and Registration

  • Université Paul Sabatier Toulouse III

    Pharm. D., Pharmacy

Skills

  • Clinical Development
  • R&D
  • Biotechnology
  • Regulatory Affairs
  • Cross-Functional Team Leadership
  • Oncology
  • Drug Development
  • Pharmacovigilance
  • Pharmaceutical Industry
  • Fda
  • Product Development
  • Regulatory Strategy
  • Regulatory Submissions
  • Cds
  • Pharmaceuticals
  • Regulatory Requirements
  • Life Sciences

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Clara Cambon Thiebaud — Board Director - Clinical Development & Regulatory Strategy at Bioliterate in Brooklyn, NY, US | Unifers