About the job
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.
Responsibilities
- 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
- 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
- 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
- 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
- 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
Qualifications
Minimum
- Education: Medical Doctor (MD) or equivalent degree with board certification in a therapeutically relevant area (preference for Cardiometabolic Disease or Neuroscience)
- Experience: 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
- 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
- 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
- Regulatory Mastery: In-depth knowledge of global regulatory requirements (e.g., FDA, EMA) and a proven track record of successful, collaborative interactions with regulatory agencies
- Computational Mindset: Genuine curiosity for cutting-edge computational, AI/ML, and data science methods and their application in clinical development
- Genetic Foundation: Strong appreciation for human genetics and its application in target identification and rigorous validation
Preferred
- 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