(Associate) Director, Clinical Affairs - Head of Infectious Diseases

(Associate) Director, Clinical Affairs - Head of Infectious Diseases

QIAGEN

Remote, Europe

Position Description

This is a Global role, we are looking for a candidate to be located within Europe. Main countries: UK, Poland, France and Spain, can be home-based.

The role will manage of a team of Clinical Study Leads to deliver clinical studies on new infectious diseases diagnostic assays and platforms, and may also manage studies directly. Working cross-functionally with both internal and external stakeholders is required to ensure high quality studies are completed on time and within budget. Leadership and management activities include: team development, identification/ addressing resource requirements, management of clinical tasks (strategy, budgeting, planning, execution), and ensuring continuous improvement of processes and team. The role-holder will use their expert knowledge in infectious diseases and clinical affairs to determine clinical strategy and ensure the scientific integrity of studies.

Key responsibilities

• Manage delivery of all infectious diseases diagnostic studies required in the specific business area with excellence, to plan and budget;
• Team management and leadership: manage team of Clinical Study Leads, identify and cultivate talents, establish framework for team development;
• Continual evaluation of clinical processes to maximise compliance and efficiency including monitoring and incorporating changing regulations and guidance documentation that concern clinical affairs;
• Develop clinical strategy and apply scientific knowledge to ensure quality clinical data is obtained.

Position Requirements

• University degree or equivalent experience in a health-related field required. Advanced degree preferred;
• Minimum 5 years’ working experience within the in vitro diagnostic devices industry; other devices or pharmaceutical experience will be considered, with experience in clinical affairs;
• Background in infectious diseases;
• Experience of direct line management and influential leadership: able to lead without authority to influence and guide decisions ensuring optimal clinical study outcomes on the behalf of clinical affairs as part of multifunctional teams. Ability to build strong rapport with core team members;
• Proficiency managing multiple high priority projects across multiple sites;
• Excellent knowledge of the in vitro diagnostic industry including product development processes (ISO13485), CLSI guidance, and ICH good clinical practice is strongly desirable;
• Willingness and availability to travel internationally: 15-20%.

Apply Now