Chief Medical Officer

About the role

The owns the end-to-end clinical development strategy that translates the Virtual Human platform into tangible patient outcomes. This leader is responsible for architecting innovative trial methodologies that leverage the company's proprietary TherML capabilities to maximize the probability of clinical success. They will design and execute Phase 1 trials to bridge translation to the clinic and establish human proof of concept for pivotal Phase 2 programs. The role requires deep translational thinking to ensure that every clinical program is built on a robust and data-driven foundation from its inception. The CMO will directly partner with AI and discovery teams to integrate computational insights into clinical design and regulatory strategy. This position demands a proven track record of leading complex drug development programs from IND submission through late-stage trials. The Chief Medical Officer will serve as the key interface between Insitro's cutting-edge science and global regulatory authorities.

Key facts

What you'll do

• Build and mentor a world-class clinical development team comprising clinical and preclinical DMPK and safety scientists, translational and biomarker scientists, regulatory experts, medical directors, and clinical trial managers.
• Design and own the execution of clinical trial protocols, Investigator Brochures, and comprehensive clinical development plans to ensure scientific and operational rigor.
• Supervise and dynamically evaluate ongoing clinical trials using a data-driven approach to guide progression, de-risking, and pivotal decision-making.
• Partner with leading external providers to establish and scale a high-efficiency global clinical trial operations platform.
• Oversee Medical Affairs, Pharmacovigilance, and Regulatory Affairs to maintain the highest global standards for patient safety, ethical conduct, and compliance.
• Lead successful interactions and submissions with major global regulatory bodies such as the FDA and EMA to secure approvals for novel clinical programs.
• Define and implement innovative clinical trial methodologies, including adaptive, basket, and Bayesian designs, that leverage AI and data science to optimize patient stratification and operational efficiency.
• Collaborate closely with AI/ML scientists, bioinformaticians, and statisticians to integrate cutting-edge computational approaches into every aspect of trial execution.
• 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.
• Work with regulatory agencies to shape and accelerate the deployment of AI methods into clinical development and pharmacovigilance frameworks.
• 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.
• Collaborate with executive leadership to guide corporate strategy and therapeutic area prioritization, anchoring decisions on unmet patient need, clinical tractability, and favorable regulatory pathways.
• Foster strategic collaborations with Key Opinion Leaders, academic institutions, and external partners to expand Insitro's scientific and clinical reach.
• Clearly articulate the company's clinical vision, strategy, and progress to both internal and external stakeholders to build trust and alignment.
• Drive the development of a best-in-class clinical development function that embodies Insitro's commitment to innovation and scientific excellence.
• Ensure that all clinical programs are positioned for efficient and successful IND submission and subsequent regulatory milestones.
• Establish a strong foundation for pharmacovigilance and regulatory affairs that supports global expansion and compliance.
• Act as a thought leader in the application of AI to clinical development, contributing to the broader scientific community and regulatory discourse.

Requirements

Candidates must possess a medical degree (MD) or an equivalent doctoral degree in medicine. Board certification or eligibility in internal medicine, pharmacology, or a related specialty is required. A minimum of 10 years of progressively responsible experience in clinical development, drug development, or translational medicine within the pharmaceutical or biotechnology industry is mandatory. Demonstrated success in designing and executing Phase 1 and Phase 2 clinical trials is essential, with a strong portfolio of programs that have advanced to proof of concept. Extensive experience in leading cross-functional teams and managing complex global clinical trial operations is required. Deep expertise in regulatory affairs, including interactions with the FDA and EMA, is a non-negotiable prerequisite. A strong understanding of pharmacometrics, pharmacokinetics, and pharmacodynamics is necessary to guide dose selection and trial design. Proficiency in interpreting complex datasets and applying statistical reasoning to solve clinical development challenges is required. Excellent written and verbal communication skills are necessary to engage with senior executives, regulatory bodies, and external partners. The ability to thrive in a fast-paced, dynamic environment where ambiguity is common is essential. Commitment to upholding the highest standards of ethics, integrity, and patient safety is mandatory. Experience in AI-driven drug development or exposure to machine learning applications in clinical development is strongly valued. A collaborative mindset and the ability to build consensus among diverse scientific stakeholders is required.

Nice to have

Preferred experience with biotechnology or pharmaceutical companies developing therapies in areas such as MASH, ALS, obesity, and dry AMD. Familiarity with adaptive trial designs and Bayesian statistical methods. Prior experience interacting with regulatory agencies on AI/ML-driven clinical development strategies.

Practical notes

This role is based in South San Francisco, California, and requires availability for approximately three days of in-office work per week or a hybrid schedule with one to two weeks of on-site presence per month. Travel may be required for meetings, regulatory interactions, and scientific conferences. The position is exempt and full-time. Insitro is an equal opportunity employer committed to diversity in the workplace.