Senior Director / Vice President, Clinical Operations

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

Compensation & Benefits at insitro

Our target starting salary for successful US-based applicants for this role is $259,000 - $312,000. 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
• Support to attend professional conferences that are meaningful to your career growth and role's responsibilities
• 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.

#LI-Hybrid

Please be aware of recruitment scams: we never request payments, all recruitment communications are from @insitro.com, and if in doubt, contact us at View email address on click.appcast.io.

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