About the role
The Opportunity The unprecedented convergence of multi-modal data, advanced disease modeling, and computational power is revolutionizing drug discovery. insitro is harnessing this moment to redefine how medicines are developed for complex diseases. Our AI/ML-enabled platforms integrate and scale data to rapidly discover novel biological insights to redefine complex diseases and identify new targets and drugs. To enable this vision we are seeking a Senior Director / Vice President of Clinical Operations who will build an AI-forward operations capability. This role will partner with Discovery, Translational Medicine, Technical Operations, Clinical, Regulatory, External R&D, Biostatistics and Procurement teams to directly improve patients' lives by leading clinical trial operations across neurological, ophthalmological and metabolic indications, advancing innovative medicines and diagnostics in a patient-focused way. You will lead the Clinical Operations function at insitro; implementing clinical operations strategies to support the development of multiple therapeutics and diagnostics. Identification of the right patients, enrolling them efficiently, and acquiring robust clinical data to inform decision making remain key challenges for clinical trial operations. You will be at the forefront of designing and implementing innovative, accelerated operations approaches, and you will have the opportunity to utilize insitro's machine learning expertise to achieve operational excellence. You will report directly to the Chief Medical Officer. This role can be either onsite (3 days per week) in our South San Francisco office or hybrid (~1 week per month) in our office. Additional travel may be needed to relevant medical and health authorities, study sites etc. This is an excellent opportunity for a seasoned Clinical Operations professional who is passionate about using their skills and experience to accelerate the drug development process and bring better drugs to the patients who can benefit most.
Responsibilities Strategic Leadership & Execution Function Ownership: Lead the Clinical Operations function with a primary focus on the IND/CTA through Clinical Proof-of-Concept phase Asset Management: Serve as the Clinical Operations lead for initial clinical-stage assets; build and manage a focused team of Clinical Operations leads as the pipeline grows Specialized Modalities: Drive trial execution utilizing laboratory and digital biomarkers, diverse therapeutic modalities, and innovative regulatory pathways across metabolic disease, neurodegeneration, and ophthalmology Accountability & Compliance End-to-End Strategy: Take full accountability for clinical operations strategy, Good Clinical Practice (GCP), and strict adherence to regulatory standards External Oversight: Own the clinical trial CRO selection and oversight process, including all site and regulatory authority clinical operations documents and interactions Data Integrity: Ensure the efficient delivery, transfer, and reporting of high-quality, source-verified clinical trial data Infrastructure & Innovation Organizational Build: Develop departmental SOPs, establish staffing and resourcing needs, and ensure operational readiness for a growing pipeline AI Integration: Direct the application of agentic AI tools, AI collaborations, and AI/ML approaches to clinical development environments Cross-Functional Collaboration: Partner with key counterparts in clinical, regulatory, computational, and translational medicine to ensure unified project delivery About You Education: BA/BS or MS in Life Sciences or equivalent experience Experience: 10+ years in Biotech/Pharma clinical operations, including leadership roles Clinical Lifecycle: Full-cycle management from FIH through NDA/BLA submission (must include Proof-of-Concept) Therapeutic Areas: Direct experience with therapeutics/biomarkers in Metabolic, Neurology, or Ophthalmology Regional Reach: Operations experience in ex-US territories (China or Australia preferred) Tech Stack: Practical exposure to AI/LLMs in clinical development. Core Competencies Regulatory: Expert knowledge of GCP, diagnostic/drug guidelines, and clinical pharmacology Execution: Proficiency in trial design, biostatistics, and computational drug development. Collaboration: Proven ability to lead cross-functional, diverse teams and translate complex data for stakeholders Leadership: Ability to drive team performance and meet high-stakes project milestones