Chief Medical Officer

THE OPPORTUNITY 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 programs in key therapeutic areas like MASH, ALS, obesity, and dry AMD advancing toward the clinic, and our first IND submission for MASH slated for the second half of this year, we are at a pivotal inflection point. Since its founding in 2018, insitro has raised approximately $800M from capital raises and discovery partnerships with pharmaceutical companies, including Bristol Myers Squibb and Eli Lilly. We are seeking an innovative, highly quantitative, and data-driven Chief Medical Officer (CMO) to architect and lead our end-to-end clinical development strategy. This role is paramount to ensuring we fully leverage our AI/ML capabilities to maximize the probability of clinical success and accelerate timelines. A key success factor in this role will be a proven track record of designing and leading the execution of Phase 1 trials bridging the gap between translational medicine and the clinic and successfully designing and delivering Phase 2 trials, establishing human POC. You will achieve this by leveraging our AI/ML capabilities to architect innovative trial designs that optimize patient selection and dosing from the outset. By imbuing translational thinking into our discovery efforts and working with our discovery teams, you will ensure that the clinical foundations for every program are built from the start to ensure optimal outcomes and rapid development. In this role, you will report directly to the CEO and be a key member of the executive leadership team. The role is either based in South San Francisco and is expected to be onsite ~3 days a week or hybrid and expected to be on-site for 1-2 weeks per month. RESPONSIBILITIES Lead and Scale Clinical Development - Build and Mentor: Continue to build, lead, and inspire a world-class team of clinical development professionals, including: clinical and preclinical DMPK and safety scientists, translational / biomarker scientists, regulatory experts, medical directors, and clinical trial managers - Design and Execute Strategy: Own the development, execution, and oversight of clinical trial protocols, Investigator Brochures, and comprehensive clinical development plans (CDPs) - Operational Excellence: Supervise and dynamically evaluate ongoing clinical trials, employing a data-driven approach to guide progression, de-risking, and pivotal decision-making - Global Platform: Partner with leading external providers to establish and scale a high-efficiency global clinical trial operations platform Regulatory and Quality Oversight - Compliance and Safety: Oversee Medical Affairs, Pharmacovigilance, and Regulatory Affairs to maintain the highest global standards for patient safety, ethical conduct, and compliance - Agency Interaction: Lead successful interactions and submissions with major global regulatory bodies (e.g., FDA, EMA) to secure approvals for insitro’s novel clinical programs Drive AI-Powered Clinical Innovation - Pioneer Trial Design: Define and implement innovative clinical trial methodologies — including adaptive, basket, and Bayesian designs — that directly leverage AI and data science to optimize patient stratification, enhance operational efficiency, and significantly increase the probability of success - Cross-Functional Leadership: Collaborate deeply with AI/ML scientists, bioinformaticians, and statisticians to integrate cutting-edge computational approaches into every aspect of trial execution - Biomarker Strategy: Design and incorporate novel, AI-derived biomarkers and robust surrogate endpoints to enable accelerated go/no-go decision-making in early and mid-stage clinical development - Regulatory Engagement: Work