Insitro
Senior Director / Vice President, Clinical Operations
South San Francisco, CA · Exec
Sponsorship not specified$259k-$312kDetected 74 days ago
GCPMachine LearningLLMsAgentic AIProcurementPharmacologyLeadershipCommunicationCollaborationGxPBiostatistics
About the role
- 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.
- Identification of the right patients, enrolling them efficiently, and acquiring robust clinical data to inform decision making remain key challenges for clinical trial operations.
Responsibilities
- 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
- External Oversight: Own the clinical trial CRO selection and oversight process, including all site and regulatory authority clinical operations documents and interactions
- Organizational Build: Develop departmental SOPs, establish staffing and resourcing needs, and ensure operational readiness for a growing pipeline
- Cross-Functional Collaboration: Partner with key counterparts in clinical, regulatory, computational, and translational medicine to ensure unified project delivery
- 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
- Support to attend professional conferences that are meaningful to your career growth and role's responsibilities
- We rely on these data to develop ML-driven, predictive disease models that uncover underlying biologic state and elucidate critical drivers of disease.
Requirements
- Direct experience with therapeutics/biomarkers in Metabolic, Neurology, or Ophthalmology
- Expert knowledge of GCP, diagnostic/drug guidelines, and clinical pharmacology
- Proficiency in trial design, biostatistics, and computational drug development.
Nice to have
- Operations experience in ex-US territories (China or Australia preferred)
Skills
- Core Competencies
- Direct the application of agentic AI tools, AI collaborations, and AI/ML approaches to clinical development environments
Compensation
- 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.
- 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.
Benefits
- 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.
- To enable this vision we are seeking a Senior Director / Vice President of Clinical Operations who will build an AI-forward operations capability.
- You will report directly to the Chief Medical Officer.
Equal opportunity
- insitro is an equal opportunity employer.
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This listing is sourced directly from Insitro's careers page and normalized into a canonical job model.