Associate Director Clinical Operations

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. This responsibility should be part of our day-to-day working life by (i) living up to high quality standards and (ii) by recognizing the sense of urgency in areas of high medical need.

Description

The Associate Director, Clinical Operations will lead the execution and delivery of all operational project activities related to a product and/or individual trials related to a product depending on the needs and skill set required. They will drive tactics and implement department and corporate strategy. They align activity within the cross functional project team which consists, at a minimum, of representatives from Medical, Quality, Clinical Supply, Clinical Operations and Regulatory Affairs departments. Projects are conducted according to International guidelines and regulations e.g. ICH-GCP, CTD, GMP.

Responsibilities (including but not limited to)

• Lead the management and execution of a clinical trial or multiple trials within a clinical program, depending on need and skillset required. This includes but is not limited to, ensuring operational logistics, cost, quality and timelines are met. The Associate Director will still have direct trial management responsibilities for trials.
• Develop and maintain budgets for study(s) that include short and long-range clinical forecasting and accruals based on clinical activity
• Collaborate with the appropriate functions in defining the outsourcing strategy for the program/project needs 
• Establish, manage and/or oversee the operational standards for the program or project (e.g., monitoring plans, risk mitigation strategy, and oversight of operational vendors (e.g., monitoring, labs, imaging, etc.) 
• Assist in the authoring and reviewing of key regulatory documents (e.g., clinical development plan, briefing packages), study protocols, investigator’s brochures, annual IND progress reports, study postings, and CSR.
• Develop in-depth knowledge of the clinical data and assures appropriate transfer of that knowledge to cross-functional study teams to achieve operational excellence 
• Provide input and works closely with Program Management 
• Ensure that study objectives are in line with the clinical development strategy and the overall corporate goals 
• Ensure that external vendors are selected and managed to deliver within established timelines and budget. This also includes site qualification and initiation 
• Support the creation of clinical operations Standard Operating Procedures (SOPs), systems, and processes across the trials; ensures compliance with regulatory and other applicable standards and guidelines 
• Collaborate with KOLs for feedback on study protocols and development plans
• Ensures effective communication channels exist and are managed across cross functional teams, including third party vendors.
• May support and/or directly manage clinical trial managers and clinical trial associates

Qualifications & Skills

• Bachelor’s degree required; advanced degree preferred; medical related degree preferred
• 8 years of strong hands on global clinical trial execution leadership at a CRO or pharmaceutical company
• Strong vendor management skills, with proven ability to build strong relationships with external vendor partners
• Ability to work independently and collaboratively in a fast paced environment
• Detail and process oriented, with excellent project management skills, including risk assessment and contingency planning.
• Effective communication and interpersonal skills; effective interaction with senior management.
• Solid well-grounded experience in vendor selection, setup, execution and operational management of domestic and international Phase 1, 2, and 3 clinical trials across an array of therapeutic areas
• Proficient in use of electronic clinical database software and other programs such as Microsoft Office
• Flexibility to travel domestically and internationally as required
• Read, write and speak fluent English
• Excellent written, oral communication and presentation skills
• Current knowledge of ICH-GCP, EU CT Directive and FDA regulations. Prior experience in Gene Therapy trials is preferable.

Core competencies

• Enthusiastic and proactive; ability to fill work gaps as needed
• Flexible
• Excellent problem-solving capabilities. Solution oriented.
• Able to cope with ambiguity, has interpersonal savvy and perseverance,
• Composure under stressful circumstances