Senior Director Regulatory Strategy

Regulatory Strategy Lead - Gene Therapy / ASO

I'm partnering with an early-stage company building a new model for personalized genetic medicine in rare and ultra-rare disease. The team is looking for a hands-on regulatory strategist who can help shape early development pathways for individualized therapeutic programs.

This is a highly entrepreneurial environment where the right person will work closely with the founder and play a meaningful role in building the regulatory framework for programs where there often is not a clear precedent to follow.

What they're looking for

• Regulatory strategy experience across gene therapy and/or ASO / oligonucleotide programs
• Direct experience leading Pre-IND and IND submissions
• Strong understanding of rare / ultra-rare disease development
• Ideally experienced with n=1 / individualized medicine programs
• Experience in a biotech, CRO, consultancy, or similarly lean environment
• Ability to lead regulatory interactions and provide practical, execution-focused guidance
• Comfortable working in ambiguous, early-stage settings where creativity and ownership are essential
• Hands-on mindset - someone who can operate strategically but also get into the details

Ideal background

The strongest fit will likely be someone who has worked on early-stage genetic medicine programs in rare disease and has personally owned agency-facing regulatory work. This person should be comfortable building from the ground up, advising on what studies/data are needed, and helping move programs forward efficiently.

This is not a traditional large-pharma regulatory role. It is best suited for someone who enjoys solving novel problems, working closely with founders, and helping define the playbook in an emerging area of medicine.

If this sounds aligned with your background, feel free to reach out.