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South San Francisco Hybrid Employment

insitro is hiring a Chief Medical Officer

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 with regulatory agencies to shape and accelerate the deployment of AI methods into clinical development and pharmacovigilance
  • Strategic Leadership and Corporate Guidance - End-to-End Input: Provide clinical leadership and strategic input across the entire drug development lifecycle, from indication selection and target validation to late-stage development and post-marketing activities
  • Shape Corporate Vision: Collaborate with other executive leaders to guide corporate strategy and therapeutic area prioritization, anchoring decisions in patient unmet need, clinical tractability, and favorable regulatory pathways
  • Broad Communication and External Engagement - Partnerships: Foster strategic collaborations with external partners, Key Opinion Leaders (KOLs), and leading academic institutions to expand insitro’s scientific and clinical reach
  • Stakeholder Communication: Effectively articulate the company's clinical vision, strategy, and progress to all critical stakeholders, including the Board of Directors, investors, and regulatory agencies

Requirements

  • Medical Doctor (MD) or equivalent degree with board certification in a therapeutically relevant area (preference for Cardiometabolic Disease or Neuroscience)
  • 20+ years of progressive experience in clinical development within the pharmaceutical or biotechnology industry, with a demonstrated track record of successful IND and NDA/BLA submissions
  • Leading role in the successful design and execution of multiple clinical trials, ideally spanning more than one therapeutic area and/or more than one therapeutic modality
  • Deep experience with the strategic use of biomarkers, including diagnostic and prognostic markers, and a history of implementing innovative or adaptive clinical trial designs
  • In-depth knowledge of global regulatory requirements (e.g., FDA, EMA) and a proven track record of successful, collaborative interactions with regulatory agencies
  • Genuine curiosity for cutting-edge computational, AI/ML, and data science methods and their application in clinical development
  • Strong appreciation for human genetics and its application in target identification and rigorous validation
  • Highly data-driven and quantitative in your decision-making, with a proven ability to collect, interpret, and leverage novel data in clinical development
  • Possess a "can-do" attitude consistent with a high-growth startup environment, combining speed, intellectual rigor, and relentless execution
  • Track record in building, scaling, and leading a high-performance clinical team
  • Exceptional ability to interact and collaborate effectively across disciplinary boundaries, including with engineers, AI scientists, and biologists
  • Outstanding interpersonal skills and the ability to convey complex medical, scientific, and computational concepts to diverse audiences spanning very different backgrounds
  • Demonstrated breadth and strategic thinking, with a transformative, future-forward approach to medical leadership

Nice to Have

  • Significant, strategic role in at least one New Chemical Entity (NCE) that has acquired full regulatory approval (BLA or NDA)
  • Direct experience applying AI/ML methods in clinical trials, including in biomarker discovery, trial design, regulatory submission packages, or operations execution
  • Experience spanning both large biopharma organizations and agile, small startups
  • Experience communicating and dealing with investors

Benefits

  • 401(k) plan with employer matching for contributions
  • Excellent medical, dental, and vision coverage as well as mental health and well-being support
  • Open, flexible vacation policy
  • Paid 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-development
  • New hire stipend for home office setup
  • Monthly cell phone & internet stipend
  • Access to free onsite baristas and daily lunch for employees who are either onsite or hybrid
  • Access to a free commuter bus network that provides transport to and from our South San Francisco HQ from locations all around the Bay Area

Work Arrangement

Hybrid — South San Francisco

About company
insitro

At insitro, we combine 20+ petabytes of automated cellular experiments with population-scale genetics to build Physical AI systems that reveal the true causal drivers of human disease and deliver targeted therapeutics.

insitro’s Virtual HumanTM is built on the world’s largest integrated multimodal corpus of human clinical and cellular data. It is a genetically anchored, causal AI engine that reveals how disease begins, progresses, and can be resolved—precisely identifying causal disease targets prior to candidate optimization.

TherMLTM is insitro’s modality-agnostic, AI-driven therapeutics design engine, spanning small molecules, oligonucleotides, and complex biologics. By matching the best-fit modality to each target and indication, TherML shifts drug discovery from stochastic screening to predictive, adaptive engineering—advancing better molecules, faster.

We’ve built a unique culture where life scientists, data scientists, engineers, and drug hunters work together to identify the most important questions, design and scale experiments, build models, and analyze the results. Our differences enhance our strengths, and our collective expertise comes together to generate scientific breakthroughs.

All jobs at insitro Visit website
Job Details
Department Clinical Development
Category other
Posted 3 months ago