Insitro · San Francisco
OtherClinical DevelopmentFullTimeposted 3mo ago
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.
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
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
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
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. We may also adjust this range in the future based on market data.
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.
In addition, insitro also provides our employees:
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
insitro is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
We believe diversity, equity, and inclusion need to be at the foundation of our culture. We work hard to bring together diverse teams–grounded in a wide range of expertise and life experiences–and work even harder to ensure those teams thrive in inclusive, growth-oriented environments supported by equitable company and team practices. All candidates can expect equitable treatment, respect, and fairness throughout the interview process.
Please be aware of recruitment scams: we never request payments, all recruitment communications are from @insitro.com, and if in doubt, contact us at info@insitro.com.
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About insitro
insitro is a drug discovery and development company using machine learning (ML) and data at scale to decode biology for transformative medicines. At the core of insitro’s approach is the convergence of in-house generated multi-modal cellular data and high-content phenotypic human cohort data. We rely on these data to develop ML-driven, predictive disease models that uncover underlying biologic state and elucidate critical drivers of disease. These powerful models rely on extensive biological and computational infrastructure and allow insitro to advance novel targets and patient biomarkers, design therapeutics and inform clinical strategy. insitro is advancing a wholly owned and partnered pipeline of insights and therapeutics in neuroscience and metabolism. Since launching in 2018, insitro has raised over $700 million from top tech, biotech and crossover investors, and from collaborations with pharmaceutical partners. For more information on insitro, please visit www.insitro.com.