Senior Director / Vice President, Clinical Operations
About The Position
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.
Requirements
- BA/BS or MS in Life Sciences or equivalent experience
- 10+ years in Biotech/Pharma clinical operations, including leadership roles
- Full-cycle management from FIH through NDA/BLA submission (must include Proof-of-Concept)
- Direct experience with therapeutics/biomarkers in Metabolic, Neurology, or Ophthalmology
- Operations experience in ex-US territories (China or Australia preferred)
- Practical exposure to AI/LLMs in clinical development.
- Expert knowledge of GCP, diagnostic/drug guidelines, and clinical pharmacology.
- Proficiency in trial design, biostatistics, and computational drug development.
- Proven ability to lead cross-functional, diverse teams and translate complex data for stakeholders
- Ability to drive team performance and meet high-stakes project milestones
Responsibilities
- Lead the Clinical Operations function with a primary focus on the IND/CTA through Clinical Proof-of-Concept phase
- 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
- Drive trial execution utilizing laboratory and digital biomarkers, diverse therapeutic modalities, and innovative regulatory pathways across metabolic disease, neurodegeneration, and ophthalmology
- Take full accountability for clinical operations strategy, Good Clinical Practice (GCP), and strict adherence to regulatory standards
- Own the clinical trial CRO selection and oversight process, including all site and regulatory authority clinical operations documents and interactions
- Ensure the efficient delivery, transfer, and reporting of high-quality, source-verified clinical trial data
- Develop departmental SOPs, establish staffing and resourcing needs, and ensure operational readiness for a growing pipeline
- Direct the application of agentic AI tools, AI collaborations, and AI/ML approaches to clinical development environments
- Partner with key counterparts in clinical, regulatory, computational, and translational medicine to ensure unified project delivery
Benefits
- Annual Performance Bonus Plan
- Equity Incentive Plan
- 401(k) plan with employer matching
- Medical, dental, and vision coverage
- 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
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Associate degree
