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Salary: USD 313,000 - 333,000 / annual
Insitro is a physical AI company developing a Virtual Human™ platform to unlock causal human biology and accelerate drug discovery. The company combines AI-driven target identification with its TherML™ platform to translate findings into therapeutics across small molecules, biologics, and oligonucleotides. With multiple programs in metabolic disease and neuroscience advancing toward the clinic and the first IND submission planned for late 2026, the company is at a critical inflection point.
You will be insitro's first dedicated Vice President of Regulatory Affairs, reporting directly to the Chief Medical Officer. This is a founding role to build the regulatory function from the ground up, developing and implementing global regulatory strategies supporting multiple therapeutic modalities and diagnostic approaches across three therapeutic areas: neurology/neurodegeneration, metabolism/cardiovascular, and ophthalmology.
Key responsibilities include: leading the entire regulatory function across diverse modalities and novel biomarkers; designing innovative regulatory approaches that enable data-driven decision-making and accelerate development cycles; serving as the primary global regulatory lead for initial clinical-stage assets, then building and managing a team of regulatory leads as the pipeline expands; owning end-to-end regulatory strategy from IND/CTA through clinical proof-of-concept; directing creation and submission of INDs, CTAs, NDAs, BLAs, and MAAs; serving as primary interface with FDA and EMA; and shaping emerging regulatory policy for AI/ML in drug development through publications, presentations, and stakeholder engagement.
You bring 10+ years of regulatory affairs experience in biotech/pharma, including direct regulatory leadership roles. You have a proven track record taking therapeutics and diagnostic biomarkers from first-in-human through proof-of-concept to NDA/BLA submission, ideally in metabolic disease, neurology, or oncology. You hold an advanced degree in life sciences, chemistry, or related discipline, with specialized regulatory science training or equivalent practical experience. You demonstrate deep command of drug, diagnostic, and device development regulations, GCP, clinical trial design, clinical pharmacology, biostatistics, and clinical operations.
You excel as a cross-functional collaborator working with clinical, translational, computational, and life scientists. You are a motivating leader who brings out the best in diverse teams. You thrive as a zero-to-one builder, energized by establishing a function from scratch—writing initial SOPs while setting department strategy. Exposure to computationally-enabled tools, biomarkers, or AI methods in regulatory approvals is preferred.
The role is hybrid: three days per week onsite in South San Francisco or approximately one week per month, with travel to medical/regulatory conferences and health authority engagements.
