Executive Director, Clinical Development (Gene Therapy)
Remote United States
Seeking an accomplished Clinical Development Leader with a strong background in Gene Therapy and / or Immunology to drive the strategic planning, trial design, and KOL engagement for our cutting-edge AAV Gene Therapy biotech.
In this pivotal role, you will lead the clinical development of our innovative pipeline, with two promising programs set to enter the clinic in 2025.
Key responsibilities include :
- Lead cross-functional teams to advance investigational therapies through the clinical pipeline.
- Interact with global health authorities, file INDs, and design / execute Phase 1 / 2 and later phase trials.
- Collaborate with therapeutic area experts and investigators to ensure clinical excellence.
- Analyze and interpret clinical data to guide strategic decisions.
- Serve as a key advisor to upper management, contributing innovative ideas that will shape programs targeting high unmet medical needs.
Qualifications :
- M.D. degree in a Scientific discipline (Gene Therapy preferred)
- Board-certified (or Eligible) Geneticists
- 4+ years of biopharmaceutical industry experience.
- Proven expertise in Gene Therapy is required and / or a depth in Immunology.
- Strong background in early development, with a track record of driving the clinical development of transformative gene therapies.
- Neurodegenerative disease experience is a plus.
- Experience in Phase 1 / 2 clinical trials.
- Demonstrated success in stakeholder engagement and advancing candidates into the clinic.
- Experience with IND filings, IBs, and protocol writing.
- Strategic thinker with strong execution skills.
- Comfortable working in a fast-paced startup environment.
If you're an expert in Gene Therapy where you've driven early development of gene therapies, led Phase 1 / 2 trials, and excel in a fast-paced startup, contact Bria Gaber at [email protected] .
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