About the position

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.nWe 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.nThe application of AI and machine learning to diagnostics and drug development is accelerating, and regulatory science is catching up in real time. You will be at the forefront of implementing and influencing new regulatory policy across multiple jurisdictions using objective, data-driven approaches, treating health authorities as key partners who share our vision of bringing better, more targeted drugs to patients faster. This role can be either onsite three days per week in our South San Francisco office or hybrid at roughly one week per month, with additional travel to medical and regulatory science conferences and health authority engagements.

Responsibilities

Own the entire regulatory function across three therapeutic areas, diverse modalities, and novel laboratory and digital biomarkers, both internally developed and in-licensedBuild regulatory approaches that enable objective, data-driven go/no-go decisions and shorten the development cycle in an evolving landscapePersonally lead regulatory strategy for our initial clinical-stage assets, then hire and manage a focused team of global regulatory leads as the pipeline growsBe accountable for global regulatory strategy from IND/CTA through clinical proof-of-concept, spanning diverse regulatory pathwaysDirect the creation, review, assembly, and submission of INDs, CTAs, NDAs, BLAs, and MAAs across clinical, CMC, device, and nonclinical functionsServe as the primary interface with FDA and EMA, oversee interactions with other global health authorities and ethics committees, and ensure adherence to good clinical practice and regulatory standardsIdentify and address regulatory risks before they become development delaysShape regulatory policy for artificial intelligence and machine learning through original publications, presentations, and stakeholder engagementInterpret regulatory requirements for project teams, the executive team, the board of directors, and the scientific advisory boardRequirements

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 roleExperience taking therapeutics and diagnostic biomarkers from first-in-human through proof-of-concept to NDA/BLA submission in metabolic disease, neurology/neurodegeneration, or oncologyAdvanced degree in life sciences, technology, chemistry, or a related discipline, with a specialized degree in regulatory science (e.g., M.S.) or equivalent practical experienceDemonstrated command of the regulations and guidelines governing drug, diagnostic, and device development, including good clinical practice, clinical trial design and execution, clinical pharmacology, biostatistics, and clinical operationsYou work effectively with people of diverse backgrounds and job functions, including clinical, translational, computational, and life scientistsYour interpersonal skills bring out the best in the people around youYou are energized by standing up a function where none exists — writing the first SOPs yourself while setting the strategy for a department that doesn’t exist yetNice-to-haves

Exposure to regulatory approvals involving computationally-enabled tools or biomarkers, ideally including AI methodsBenefits

Annual Performance Bonus PlanEquity Incentive Plan401(k) plan with employer matchingMedical, dental, and vision coverageMental health and well-being supportOpen, flexible vacation policyPaid parental leave of at least 16 weeks to support parents who give birth, and 10 weeks for a new parent (inclusive of birth, adoption, fostering, etc)Quarterly budget for books and online courses for self-developmentNew hire stipend for home office setupMonthly cell phone & internet stipendAccess to free onsite baristas and daily lunch for employees who are either onsite or hybridAccess to a free commuter bus network that provides transport to and from our South San Francisco HQ from locations all around the Bay Area