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

At the heart of QIAGEN’s business is a vision to make improvements in life possible.

We are on an exciting mission to make a real difference in science and healthcare. We are still the entrepreneurial company we started out as and have today achieved a size where we can bring our full power to many initiatives and to our presence across the globe.
Our most valuable asset are our employees – around 6000 in over 35 locations around the world. Our ambition is to ensure we have outstanding and passionate people working in the best teams and we are constantly looking for new talent to join us.
There are few players who have shaped the world of modern science and healthcare as much as QIAGEN, and we have only just started.
If you are looking to advance your career, are seeking new challenges and opportunities, enjoy working in dynamic, international and diverse teams and want to make a real impact on people’s lives, then QIAGEN is where you need to be.

Join us. At QIAGEN, you make a difference every day.

Overview

At the heart of QIAGEN’s business is a vision to make improvements in life possible.

We are on an exciting mission to make a real difference in science and healthcare. We are still the entrepreneurial company we started out as and have today achieved a size where we can bring our full power to many initiatives and to our presence across the globe.
Our most valuable asset are our employees – around 6000 in over 35 locations around the world. Our ambition is to ensure we have outstanding and passionate people working in the best teams and we are constantly looking for new talent to join us.
There are few players who have shaped the world of modern science and healthcare as much as QIAGEN, and we have only just started.
If you are looking to advance your career, are seeking new challenges and opportunities, enjoy working in dynamic, international and diverse teams and want to make a real impact on people’s lives, then QIAGEN is where you need to be.

Join us. At QIAGEN, you make a difference every day.

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%.

What we offer

At the heart of QIAGEN are our people who drive our success. We act with passion, always challenging the status quo to drive innovation and continuous improvement. We inspire with our leadership and make an impact with our actions. We create a collaborative, safe and engaging workplace which forms the basis for high performing individuals and teams. We drive accountability and entrepreneurial decision-making and want you to excel your growth and shape the future of QIAGEN.

QIAGEN is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, or disability.