Senior Director Regulatory Strategy

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