The Opportunity

insitro is pioneering a new approach to drug discovery and development, enabled by the use of machine learning to interrogate large amounts of both cellular and clinical data to increase the probability of clinical success. At a time when several of insitro’s therapeutic discovery programs are heading towards the clinic, we are seeking an innovative, data-driven Chief Medical Officer, who will drive our development strategy, and ensure that we maximize our machine learning capabilities both to increase the success of our clinical programs and to accelerate them. This effort will involve a careful design of innovative, adaptive clinical trials, using machine learned biomarkers on high-content clinical and real-world data to select the right patients, to optimize dosing regimens (including combinations), and to craft quantitative, clinically significant endpoints.

Your work will therefore begin well before our programs enter the clinic, as you partner with our discovery, translational medicine and operations teams to help lay the foundation for these novel clinical trial designs. In addition to your scientific role, you will also be a partner in hiring the team, and in setting the culture of the company to ensure teamwork across people of very diverse subject areas.

Your primary duties will be:

Lead all aspects of Clinical Development:

• Build and lead a team of clinical development professionals, including clinical scientists, medical directors, and clinical trial managers
• Drive the development and execution of clinical trial protocols, investigator brochures, and clinical development plans
• Supervise and evaluate ongoing clinical trials, making data-driven decisions to optimize trial progress or appropriate termination
• In partnership with leading external providers, develop a groundbreaking global trial operations platform

Drive strategy on clinical trial design and innovation:

• Own the development and implementation of innovative clinical trial designs that leverage AI and data analytics to optimize patient recruitment, improve trial efficiency, and increase the probability of success
• Collaborate with cross-functional teams, including machine learning scientists, bioinformaticians, and statisticians, to craft and implement ground breaking clinical trials that incorporate adaptive and Bayesian methodologies
• Design and incorporate novel biomarkers and surrogate endpoints to accelerate decision-making in clinical development

Collaborate on broader company strategy:

• Provide medical leadership and strategic input across all stages of drug development, from target identification to post-marketing activities
• Work with other company leaders to guide our corporate and therapeutic area strategy, bringing in perspectives on patient unmet need, tractability of clinical development and availability of regulatory pathways

Regulatory affairs:

• Oversee medical affairs, pharmacovigilance, and regulatory affairs to maintain the highest standards of patient safety and compliance
• Ensure compliance with global regulatory standards and guidelines, working closely with regulatory affairs to support successful submissions and approvals

Broader communication:

• Foster collaborations with external partners, key opinion leaders, and academic institutions to enhance our scientific and clinical capabilities
• Effectively communicate the company's clinical strategy and progress to stakeholders, including the board of directors, investors, and regulatory agencies

About You

Scientific experience

• Medical Doctor (MD) or equivalent degree with board certification in a relevant therapeutic area (oncology, metabolic disease, immunology, or neuroscience) 20+ years of proven experience in clinical development within the pharmaceutical or biotechnology industry, with a track record of successful IND and NDA submissions. Leading role in the design and execution of multiple clinical trials, ideally across more than one therapeutic area, with at least one regulatory approval
• Experience with the use of complex biomarkers in clinical development, as well as innovative clinical trial designs
• In-depth knowledge of regulatory requirements, including FDA and EMA guidelines, and a track record of successful interactions with regulatory agencies
• Curiosity about cutting-edge computational and data science methods Appreciation for human genetics and its use in target identification or validation

Leadership/personality traits

• Data-driven, quantitative approach, and a track record of collecting and using data in clinical development
• Track record in building and leading a high-performance team, with extensive experience at the executive level
• Ability to interact optimally across disciplinary boundaries, including people from a diverse set of backgrounds
• A can-do demeanor consistent with a startup environment, including the ability to move quickly, work hard, and do what it takes to be successful
• Excellent interpersonal skills, including the ability to convey complex medical and scientific concepts to diverse audiences
• Demonstrated critical thinking and a transformative approach to medical leadership in the context of AI-driven drug development

Nice to have

• Significant strategic role in at least one NCE that has acquired full regulatory approval (BLA or NDA)
• Experience working across multiple therapeutic modalities
• Experience working across multiple therapeutic areas
• Experience in both large biopharma and small startups