3h ago
Head of Clinical Operations
Cambridge, MA
full-timedirectorbiotechnology
Description
You will lead the transition of internal programs from discovery to clinical-stage execution, building the Clinical Operations function, team, and systems. This high-impact role bridges long-term strategy with tactical excellence, leveraging AI to manage a large clinical portfolio with speed and high probability of success.
Requirements
- Bachelor’s in life sciences or related field
- Visionary leadership to build Clinical Operations function
- Experience in oncology and/or inflammation therapeutic areas
- Expertise in clinical trial management and GxP systems
- Ability to manage CROs and vendors globally
Responsibilities
- Establish Clinical Operations capabilities, infrastructure, SOPs, and GxP systems for clinical-stage transition
- Provide strategic input into risk management, therapeutic area expertise, and long-range planning
- Drive operational roadmap from IND enabling studies through FIH, POC, and pivotal trials
- Manage study start-up activities including feasibility, site selection, and contract negotiations
- Collaborate with cross-functional teams to develop TPPs, CDP, and study-specific documents
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