Insitro

Insitro

Chief Medical Officer

South San Francisco, CA · Exec

Sponsorship not specified$450k-$480kDetected 54 days ago
Machine LearningData ScienceStakeholder ManagementClinical TrialsFDA RegulatoryPharmacovigilanceAnimal StudiesLeadershipCommunicationRegulatory Affairs

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.
  • 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.

Responsibilities

  • Lead and Scale Clinical Development
  • Design and Execute Strategy: Own the development, execution, and oversight of clinical trial protocols, Investigator Brochures, and comprehensive clinical development plans (CDPs)
  • Global Platform: Partner with leading external providers to establish and scale a high-efficiency global clinical trial operations platform
  • 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
  • Partnerships: Foster strategic collaborations with external partners, Key Opinion Leaders (KOLs), and leading academic institutions to expand insitro's scientific and clinical reach
  • Leadership Track Record: 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

Requirements

  • 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
  • Highly data-driven and quantitative in your decision-making, with a proven ability to collect, interpret, and leverage novel data in clinical development
  • Biomarker Acumen: Deep experience with the strategic use of biomarkers, including diagnostic and prognostic markers, and a history of implementing innovative or adaptive clinical trial designs

Nice to have

  • Significant, strategic role in at least one New Chemical Entity (NCE) that has acquired full regulatory approval (BLA or NDA)
  • Experience spanning both large biopharma organizations and agile, small startups
  • Experience communicating and dealing with investors

Compensation

  • Our target starting salary for successful US-based applicants for this role is $450,000- $480,000.
  • To determine starting pay, we consider multiple job-related factors including a candidate's skills, education and experience, market demand, business needs, and internal parity.
  • This role is eligible for participation in our Annual Performance Bonus Plan (based on company targets by role level and annual company performance) and our Equity Incentive Plan, subject to the terms of those plans and associated policies.

Benefits

  • To determine starting pay, we consider multiple job-related factors including a candidate's skills, education and experience, market demand, business needs, and internal parity.
  • Effectively articulate the company's clinical vision, strategy, and progress to all critical stakeholders, including the Board of Directors, investors, and regulatory agencies
  • 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)

Company info

  • 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.

Equal opportunity

  • insitro is an equal opportunity employer.
Apply directly at Insitro →Create a free account for alerts like thisView Insitro immigration profile

This listing is sourced directly from Insitro's careers page and normalized into a canonical job model.