Senior Clinical Operations Leader — Complex Programs

Immunocore Ltd.; Gaithersburg (MD); Sur place; USD 175 000 - 190 000; Plein temps

Résumé du poste

Immunocore Ltd. in Gaithersburg, MD (with proximity to Radnor, PA) seeks an Associate Director of Clinical Operations to lead the operational delivery of complex programs.

The role interfaces with portfolio leaders and cross-functional teams to meet timelines, quality standards, and budgets. The successful candidate will guide study strategy, contribute to regulatory documentation, and ensure program-wide coordination from planning through execution, while providing executive updates and

Qualifications

• Essential Qualifications: BA / BS. or higher in science related field (biological science, pharmacy or other health related discipline)
• At least 10 years relevant experience in a biotechnology/pharmaceutical industry and/or clinical research organization
• Experience in early phase clinical studies/Phase I-III studies and global/international studies or programs
• Experience in oncology, Autoimmune or Infectious Disease is highly desired
• Demonstrated computer skills; proficiency in MS Office and ability to develop proficiency in Immunocore IRT and EDC systems
• Experience in applying principles of effective clinical project practices, supporting stakeholders for successful delivery
• Vendor Oversight experience
• Expertise in global regulatory and compliance requirements for clinical research (US CFR, EU CTD, ICH GCP)
• Knowledge of GCP, ICH, GDP and relevant CFRs
• Experience presenting high level presentations

Responsabilités

• Oversee operational delivery of one or more complex programs or studies
• Be the primary contact for assigned programs in the operational team for portfolio leaders
• Lead cross-functional collaboration to ensure on-time study delivery within budget
• Develop program strategy and operational plans linked to value drivers and timelines
• Review clinical documents and provide input on study protocols and reports
• Provide regular executive updates to senior management
• Ensure inspection readiness and manage study budgets with Outsourcing Management and Finance
• Participate in vendor selection and management of CROs and other vendors
• Support governance and process improvements within Clinical Operations

Connaissances

MS Word

MS Excel

MS PowerPoint

MS Project

SharePoint

Immunocore IRT

EDC systems

Outlook

MS Office suite

Formation

BA/BS in science-related field

Outils

Immunocore IRT

EDC systems

Description du poste

Immunocore Ltd. in Gaithersburg, MD (with proximity to Radnor, PA) seeks an Associate Director of Clinical Operations to lead the operational delivery of complex programs.

The role interfaces with portfolio leaders and cross-functional teams to meet timelines, quality standards, and budgets. The successful candidate will guide study strategy, contribute to regulatory documentation, and ensure program-wide coordination from planning through execution, while providing executive updates and