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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