Translational Study Manager

il y a 2 semaines

Paris, Île-de-France Barrington James Temps plein

Translational Study Manager (Gene Therapy, Ophthalmology)

Location: Paris (on-site / hybrid)

About the role:

I'm working with a unique venture-backed European biotech is advancing a next generation gene therapy platform focused on precision delivery in ophthalmology. This is a hands on, high impact role in a fast moving biotech environment. The company is progressing its lead program toward first-in-human studies and is building a lean, high calibre translational team to support IND enabling development.

This role sits at the critical junction between preclinical science and clinical readiness.

Role Overview:

The Translational Study Manager will lead the design, execution, and oversight of IND enabling preclinical studies required to transition gene therapy candidates into the clinic. You job will bet to own outsourced study delivery across biodistribution, toxicology and safety, ensuring scientific rigor, regulatory alignment and execution through CRO partners.

You Will

  • Design and deliver
    IND-enabling preclinical studies
    (GLP & non-GLP), including biodistribution, toxicology, and safety
  • Author and critically review
    study protocols
    , ensuring scientific robustness and regulatory relevance
  • Lead
    CRO selection, qualification, and management
    , including scopes of work and service agreements
  • Monitor study progress, timelines, budgets, and milestones across external partners
  • Perform
    critical scientific review of raw data, interim analyses, and final reports
  • Coordinate development and validation of
    bioanalytical assays
    (e.g. qPCR/ddPCR, immunoassays)
  • Proactively identify and resolve risks related to quality, timelines, or cost
  • Ensure full compliance with
    regulatory and quality standards
  • Contribute to
    regulatory documentation
    supporting clinical trial applications
  • Collaborate cross-functionally with research, development, and regulatory colleagues

Essential Experience

  • PhD in Life Sciences, Biotechnology, or a related discipline
  • 5+ years' experience
    in preclinical in vivo and/or translational development
  • Hands-on experience in ophthalmology animal models is essential
  • Strong understanding of
    IND-enabling study design
  • Proven experience managing CROs end to end (selection, oversight, contracts)
  • Gene therapy experience strongly preferred (biotech or pharma)
  • Non human primate study experience is a plus
  • Fluent English required; additional European languages advantageous

What I'm looking for in candidates

  • Strong data driven judgement
    (someone who is scientifically rigorous)
  • Delivery focused
    (knows what to do and how to do it)
  • Someone comfortable managing multiple external programs in parallel
  • A proactive problem solver who anticipates issues before they escalate
  • Collaborative mindset, a communicator with good experience working across stakeholders

Why This Role

  • Direct ownership of
    IND enabling strategy and execution
  • Exposure to a
    first in class gene therapy delivery platform
  • Small team, high accountability, visible impact
  • Strong investor backing and clear clinical trajectory

  • Translational Pharmacology

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