Associate Director, Associate Clinical Operations Asset Lead (aCOAL)
Core
Lead operational strategy and delivery for complex oncology late-phase clinical development streams, ensuring alignment with clinical development plans and regulatory-grade data quality.
Role type
Senior IC Associate Clinical Operations Asset Lead (Oncology)
Builds
Late-phase oncology clinical studies and global development programs
Domain
Biopharma / Oncology / Clinical Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Oncology clinical development, Vendor management (CRO oversight), Good Clinical Practice (GCP), Global study oversight, Protocol development, Operational feasibility assessment, Risk management, Budget forecasting
Preferred skills
Phase II-III program management, Multi-indication program experience, Regulatory submission support, Clinical supplies/bio-sample management, Matrix team leadership, Mentoring
Technologies
Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), Statistical software
Responsibilities
Lead operational strategy for late-phase development streams; Coordinate cross-functional inputs from clinical, biostatistics, safety, and vendors; Represent DevOps at EDT/MDT; Contribute to protocol development and resourcing decisions; Maintain inspection readiness and quality oversight; Provide operational input for regulatory deliverables and governance forums; Act as a point of contact for stakeholders and vendors.
Seniority
Senior, hands-on IC with strategic influence
