At insitro, we are building a different kind of drug company to bring better drugs faster to the patients who can benefit most. Through the power of machine learning (ML) and data at scale, we decode the complexities of biology to unlock transformative new... Backed by SoftBank VF, a16z and GV.
About the role
insitro is a physical AI company dedicated to unlocking causal human biology and accelerating the delivery of better medicines to patients. Our unique Virtual Human™ platform identifies novel, high-impact genetic intervention points, which our TherML™ platform translates into therapeutics—whether small molecules, biologics, or oligos.
What they're looking for
- Proven Tenure: 10+ years of experience in regulatory affairs in the biotechnology and/or pharmaceutical industries, including time directly as a regulatory lead and in a leadership role
- Clinical Delivery Track Record: Experience taking therapeutics and diagnostic biomarkers from first-in-human through proof-of-concept to NDA/BLA submission in metabolic disease, neurology/neurodegeneration, or oncology
- Education: Advanced degree in life sciences, technology, chemistry, or a related discipline, with a specialized degree in regulatory science (e.g., M.S.) or equivalent practical experience
- Computational Regulatory Experience: Exposure to regulatory approvals involving computationally-enabled tools or biomarkers, ideally including AI methods
More about this role
insitro is a physical AI company dedicated to unlocking causal human biology and accelerating the delivery of better medicines to patients. Our unique Virtual Human™ platform identifies novel, high-impact genetic intervention points, which our TherML™ platform translates into therapeutics—whether small molecules, biologics, or oligos. With multiple programs in metabolic disease and neuroscience advancing toward the clinic, and our first IND submission slated for the second half of this year, we are at a pivotal inflection point.
We are seeking a Vice President of Regulatory Affairs to build our regulatory function from the ground up. Reporting directly to the Chief Medical Officer, you will develop and implement global regulatory strategies supporting multiple therapeutics — small molecules, biologics, and oligonucleotides — and diagnostics across our three therapeutic areas: neurology/neurodegeneration, metabolism/cardiovascular, and ophthalmology. This is a founding role: you will be insitro's first dedicated regulatory leader, shaping the function's strategy, systems, and team as our first programs reach the clinic.
The application of AI and machine learning to diagnostics and...
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