Senior Director / Vice President, Clinical Operations
insitroAI-driven Drug company
South San Francisco, United StatesDirector
Andreessen Horowitz
BlackRock
CPP Investments
ARCH Venture Partners
Third Rock Ventures
Two Sigma Ventures
Operations & Strategy
About the role
TL;DR
Lead clinical operations for drug development at insitro.
- •Lead the Clinical Operations function at insitro; implementing clinical operations strategies to support the development of multiple therapeutics and diagnostics.
- •Key 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 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 Requirements 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) Thera
Required skills
Compliance ManagementStrategic Planning
Domain expertise
healthcare