Senior Clinical Operations Lead

Immunocore

Radnor (Delaware County)

On-site

USD 175,000 - 190,000

Full time

8 days ago

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Job summary

Immunocore is seeking an Associate Director of Clinical Operations to oversee complex programs and cross-functional teams across global studies, ensuring timelines, quality, and budgets are met. You will drive operational strategy, collaborate with CROs and internal stakeholders, and provide executive updates.

Essential qualifications include a science BA/BS with 10+ years in biotech/pharma or CRO settings, oncology or related areas, and strong regulatory and GCP knowledge.

Qualifications

  • BA/BS in science; 10+ years' biotech/pharma or CRO experience; clinical study management in Phase I–III and global studies.
  • Experience in oncology, autoimmune, or infectious disease is highly desired.
  • Strong computer skills; proficient with MS Office and Immunocore IRT/EDC systems.
  • Vendor oversight and global regulatory knowledge (US CFR, EU CTD, ICH-GCP).
  • Proven project/program management and matrix leadership.

Responsibilities

  • Oversee one or more complex programs or studies, delivering milestones on time and budget.
  • Be the key operations contact for portfolio leaders and cross-functional teams.
  • Participate in program strategy meetings and develop operational plans.
  • Lead cross-functional teams to ensure on-time program delivery and data quality.
  • Foster partnerships to standardize study delivery, data collection and reporting.
  • Provide direction and support to Clinical Operations; develop strategy and scenarios.
  • Review clinical documents (protocols, SAPs, study reports) for drug development.
  • Provide regular executive updates to senior management.
  • Ensure inspection readiness and manage risks across studies.
  • Support study budget negotiations; coordinate with outsourcing, finance, and leadership.
  • Participate in CRO/vendor selections and management throughout studies.
  • Collaborate with internal/external teams to align milestones with company strategy.
  • Identify and escalate program issues impacting budget/resources/timelines.
  • Contribute to governance committees and SOP development.

Skills

Project management
Cross-functional leadership
Vendor management
Global regulatory knowledge
GCP/ICH familiarity
Strategic planning
Communication skills
Presentation skills
Independent work

Education

Bachelor's degree in science

Tools

MS Word
MS Excel
MS PowerPoint
MS Project
SharePoint
Immunocore IRT systems
EDC systems

Job description

Immunocore is seeking an Associate Director of Clinical Operations to oversee complex programs and cross-functional teams across global studies, ensuring timelines, quality, and budgets are met. You will drive operational strategy, collaborate with CROs and internal stakeholders, and provide executive updates.

Essential qualifications include a science BA/BS with 10+ years in biotech/pharma or CRO settings, oncology or related areas, and strong regulatory and GCP knowledge.

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