Associate Director, Clinical Operations

Amsterdam Area
Hybrid ✅
Full-time
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Apply before: 
Mar 17, 2024

Job Description

uniQure is dedicated to bringing innovative therapies for unmet medical needs to patients. In doing so, each function in uniQure is directly or indirectly responsible for the lives of patients, and this responsibility is incorporated into our day-to-day work by living up to high-quality standards and by recognizing a sense of urgency in areas of high medical need.

Clinical Operations Associate Director (AD)/ Director

The Clinical Operations Associate Director (AD)/ Director is a highly skilled, outside of the box thinker and a top-performing expert in the business of developing new drugs and clinical project management. The AD/Director is the expert on the critical aspects of the study and is responsible for overall execution and delivery of the program activities including the direct line management of the Clinical Operations team members assigned to this program. This individual will be part of the Clinical Operation leadership team and will be tasked to drive and implement departmental and corporate level strategy plans and process improvement initiatives.

Key Result Areas (major duties, accountabilities, and responsibilities)

  • Accountable for oversight and delivery of a program to achieve agreed timelines, scope, quality, and budget and in accordance with ICH-GCP, uniQure policies, and applicable SOPs
  • Leads the Clinical Operations execution of development strategies for a program and effectively plans, leads, codifies, and evaluates trials across a range of phases and regions
  • Coordinates strategy and stakeholder alignment to effectively execute plans, communicate big-picture implications and considerations of development strategies
  • Maintains focus on long-term strategy while successfully adapting to changing environmental conditions
  • Manage, train and direct Clinical Trial Manager(s) and Clinical Trial Associate(s) and act as an escalation level for decision making related to the program risks
  • Manages staffing to ensure adequate resources are assigned to achieve project deliverables, in collaboration with Clinical Operations leadership
  • Actively contributes to cross-functional discussions on the development strategy the program as part of the program clinical development team
  • Provides timely and accurate input to Clinical Development Plans including timeline forecasting, feasibility assessment for protocol design, resource estimation, and project-level budget
  • Leads Clinical Operations efforts in completing relevant sections of document filings
  • Writes or oversees writing (in collaboration with technical experts) of clinical trial protocol(s) and amendment(s), Clinical Study Reports (CSR), and reviews all clinical trial-related documents
  • Influences and drives cross-functional patient-centric strategies for trial execution
  • Understands Investigational Medicinal Product (IMP) labeling, distribution, and clinical supply
  • Demonstrates solutions-oriented mindset to troubleshoot study-specific procedures, providing guidance to cross-functional subject matter experts.
  • Communicates organizational strategies, plans, procedures, and objectives of career development infrastructure
  • Monitors compliance with ICH-GCP, uniQure policies, and applicable SOPs, Supports inspection readiness procedures
  • Directs vendor selection, contracting and management, and leads efforts to monitor vendor performance in order to ensure timely delivery of contracted activities

Qualifications & Skills

  • Minimum of 9 - 12 years of Clinical Operations/ Clinical Development experience with a minimum of 3 years leadership experience, and a minimum of 5 years’ experience either in a CRO or a pharmaceutical company
  • Experienced in conducting complex clinical research projects and early drug development, with preferred experience in gene therapy. Proven substantial experience in rare/ ultra-rare disease is a must
  • Demonstrates a deep understanding of key global regulations that affect program and trial design and proactively recommends optimizations of the program execution including countries participating considering regulatory aspects
  • Excellent track record of consistently delivering high-quality outcomes to patients and internal and external stakeholders both individually and as a leader of teams and functions
  • Demonstrates a deep understanding and application of ICH/GPP, EU CTR, and FDA regulations, as well as other GxP regulations in the context of trial execution; understands regulatory environmental changes and impact on trial design and execution
  • Demonstrates exceptional ability to build and maintain strong working relationships in departmental and cross-functional efforts of multiple individuals, workgroups, or teams to accomplish a project or corporate goals
  • Augment tactical skills with the ability to think and act strategically
  • Strong people manager with a proven track record of leading successful teams
  • Strong vendor management skills
  • Excellent interpersonal and communication skills, including written, oral communication, and presentation skills
  • Detail and process-oriented, with excellent project management skills, including risk assessment and contingency planning
  • Excellent problem-solving capabilities; solution-oriented
  • Demonstrates the ability to establish a team culture that values the importance of innovative technology in bringing efficiency to operations and can lead organization-wide change efforts to improve technological elements of Clinical Operations
  • Demonstrates exceptional ability to deal with interpersonal and/or politically challenging situations diplomatically
  • Able to read, write and speak fluent English
  • Bachelor’s degree required; master’s degree preferred

Core and Technical Competencies

uniQure Clinical Operations has defined a set of core and technical competencies that inform the work we do and how we do it. These competencies align with our ability to achieve uniQure’s strategic intent and have been defined for Clinical Operations employees at all career levels to provide clear expectations for their current role, where they fit within the organization, and what it looks like to operate at the next level.

Core Competencies

  • Collaboration
  • Communication and transparency
  • Achieving Results
  • Problem Solving and Decision Making
  • Self-Awareness
  • Flexibility and Responsiveness
  • Managing and Improving Processes
  • Influencing and Persuading
  • Leading with integrity
  • Managing & Developing People

Technical Competencies

  • Drug Development
  • GCP
  • Technology
  • Processes, Procedures, and Best Practices
  • Regulatory Environment
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Apply before: 
Mar 17, 2024

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