Head of Clinical Operations

A Curie.Bio portfolio company who is developing an oral therapy targeting benign hematology disorders is seeking a Fractional Clinical Operations Consultant to help build and execute its early clinical development infrastructure as the company advances toward first-in-human studies.

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Key Responsibilities

Clinical Operations Strategy & Execution

• Lead clinical operations planning for a Phase 1 healthy volunteer study (Australia-based)
• Translate clinical development strategy into operational plans and timelines
• Support IND-enabling activities and transition into the clinic

CRO Selection & Oversight

• Solicit, evaluate and refine proposals from clinical CROs
• Lead clinical CRO selection process
• Oversee CRO scope, performance, and deliverables
• Develop and manage clinical trial budgets and timelines

Vendor & Infrastructure Build-Out

• Establish clinical operations infrastructure, including:
• Data management strategy (in-house vs CRO-based)
• Central and specialty lab selection (PK, biomarkers) and management
• Lab kit and manual development
• Coordinate cross-functional vendors to ensure trial readiness

Quality & Process Development

• Help design and implement a fit-for-purpose Quality Management System (QMS) as the company approaches clinical stage
• Ensure operational readiness for regulatory and clinical execution

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Preferred Experience

• Strong clinical operations leadership experience, including early-phase trials
• Direct experience running or supporting Phase 1 healthy volunteer studies
• Experience with CRO selection and oversight, including budget management
• Familiarity with Australia-based clinical trials preferred
• Background in hematology or myeloproliferative disorders (PV, ET, myelofibrosis) is a plus
• Experience building clinical infrastructure in early-stage biotech environments

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How to Apply

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