Aimed at senior clinical development leaders who integrate AI/ML into trial design and execution, requiring onsite presence in South San Francisco.
Derived from job-description analysis by Serendipath's career intelligence engine.
Original posting from Insitro via Ashby
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 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 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
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 development
- Operational Excellence with a Startup Mentality: Possess a "can-do" attitude consistent with a high-growth startup environment, combining speed, intellectual rigor, and relentless execution
- Team Builder: Track record in building, scaling, and leading a high-performance clinical team
- Collaborative: Exceptional ability to interact and collaborate effectively across disciplinary boundaries, including with engineers, AI scientists, and biologists
- Communication: Outstanding interpersonal skills and the ability to convey complex medical, scientific, and computational concepts to diverse audiences spanning very different backgrounds
- Strategic Thinker: 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 deali
Source: Insitro careers (Ashby)