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

About You

Scientific and Clinical Expertise: We prioritize agility of thinking that would allow effective execution across multiple TAs, with experience in metabolic disease or neuroscience being highly desirable. 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 submissionsLeadership 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 modalityBiomarker Acumen: Deep experience with the strategic use of biomarkers, including diagnostic and prognostic markers, and a history of implementing innovative or adaptive clinical trial designsRegulatory Mastery: In-depth knowledge of global regulatory requirements (e.g., FDA, EMA) and a proven track record of successful, collaborative interactions with regulatory agenciesComputational Mindset: Genuine curiosity for cutting-edge computational, AI/ML, and data science methods and their application in clinical developmentGenetic Foundation: Strong appreciation for human genetics and its application in target identification and rigorous validation Leadership and Personal Attributes: Quantitative Approach: Highly data-driven and quantitative in your decision-making, with a proven ability to collect, interpret, and leverage novel data in clinical developmentOperational Excellence with a Startup Mentality: Possess a "can-do" attitude consistent with a high-growth startup environment, combining speed, intellectual rigor, and relentless executionTeam Builder: Track record in building, scaling, and leading a high-performance clinical teamCollaborative: Exceptional ability to interact and collaborate effectively across disciplinary boundaries, including with engineers, AI scientists, and biologistsCommunication: Outstanding interpersonal skills and the ability to convey complex medical, scientific, and computational concepts to diverse audiences spanning very different backgroundsStrategic Thinker: Demonstrated breadth and strategic thinking, with a transformative, future-forward approach to medical leadership