Senior Clinical Operations Leader - Complex Studies

BioSpace

Radnor (Delaware County)

On-site

USD 175,000 - 190,000

Full time

7 days ago
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Job summary

Immunocore is seeking an Associate Director of Clinical Operations to oversee complex study programs and lead cross-functional teams to ensure timely, budget-conscious, and high-quality delivery. The role requires extensive experience in biotech/pharma clinical operations and global study oversight.

You will provide strategic operational input across trial documents, manage budgets, and interact with senior leadership to drive regulatory milestones and study success.

Qualifications

  • BA/BS or higher in science related field.
  • At least 10 years relevant experience in biotech/pharma and/or CRO with focus on clinical study/project management.
  • Experience in oncology, autoimmune, or infectious disease projects.
  • Familiarity with regulatory requirements (GCP/ICH/US CFR) and global regulatory environment.

Responsibilities

  • Oversee operational delivery of complex programs or studies ensuring milestones are met within budget and quality.
  • Serve as key point of contact for assigned programs in the operations team.
  • Participate in program strategy meetings and guide operational strategy.
  • Lead cross-functional teams to deliver programs on time and within budget.
  • Develop program/study operational plans including scenarios that optimize delivery and value.
  • Review clinical documents (synopsis, protocols, study reports) for expert input.
  • Provide regular executive updates to senior management.
  • Ensure inspection readiness and manage spend with outsourcing and finance teams.
  • Sponsor CRO/vendor selection and management throughout the study lifecycle.
  • Support governance with vendors and participate in department initiatives.

Education

BA/BS in science

Tools

MS Office
Immunocore IRT
EDC systems
SharePoint

Job description

Immunocore is seeking an Associate Director of Clinical Operations to oversee complex study programs and lead cross-functional teams to ensure timely, budget-conscious, and high-quality delivery. The role requires extensive experience in biotech/pharma clinical operations and global study oversight.

You will provide strategic operational input across trial documents, manage budgets, and interact with senior leadership to drive regulatory milestones and study success.

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