Clinical Science Manager – Oncology

TN United Kingdom; United Kingdom; On-site; GBP 50,000 - 90,000; Full time

Job summary

Join a dynamic and innovative company dedicated to advancing science and healthcare. As a Clinical Science Manager, you will play a pivotal role in managing clinical evaluations and collaborating with diverse teams to ensure compliance with international regulations. This position offers the opportunity to make a significant impact in the field of oncology and companion diagnostics. With a commitment to employee development and a supportive workplace culture, this role is perfect for those looking to grow their careers in a meaningful way. Embrace the chance to work in a collaborative environment where your contributions truly matter.

Benefits

Attractive pension

Private Healthcare

Private Dentalcare

Gym membership contribution

Employee Assistance Programme

Retail discounts

Enhanced maternity package

Flexible working options

Bonus/commission

25 days annual leave

Qualifications

• 3+ years of experience in IVDs or clinical settings, especially in oncology.
• Strong knowledge of regulatory requirements and clinical guidelines.

Responsibilities

• Manage clinical evaluation plans and reports for IVDs and Companion Diagnostics.
• Collaborate with internal and external stakeholders to ensure compliance.

Skills

In vitro diagnostics

Clinical research

Project management

Regulatory compliance

Oncology expertise

Education

Master's degree in Life Sciences

PhD in Life Sciences

Tools

FDA CFR

ISO13485

ISO14971

ISO20916

Job description

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Clinical Science Manager – Oncology, united kingdom

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Client:

QIAGEN

Location:

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

ad3fe0942bec

Job Views:

7

Posted:

26.04.2025

Expiry Date:

10.06.2025

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Job Description:

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 – more than 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 and international, 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 role within the Clinical Science team of Clinical Affairs will serve as a Clinical Expert contributing towards gathering clinical evidence and presenting it to regulatory bodies in support of the In-vitro Diagnostic (IVD) product range within QIAGEN, primarily focused on the Oncology and Companion Diagnostics portfolio. The post-holder is accountable for managing performance evaluation for IVDs as well as contributing to clinical strategy, study protocols, study reports and post market surveillance activity. The post-holder will coordinate the efforts and activities of diverse internal and external stakeholders, ensuring compliance with organizational SOPs and international regulations.

Key responsibilities

- Managing the delivery of clinical/performance evaluation plans, scientific validity reports clinical/performance evaluation reports to support Global Clinical Affairs activities around medical device (MD)/IVD and Companion Diagnostics development, registration and marketing, ensuring accuracy of information, data and referencing for the documents produced.

- Manage external contractors and vendors, ensuring projects are delivered within budget and to timeline.

- Collaborate with internal project stakeholders (including but not limited Medical Affairs, Product Development, Quality, Regulatory) and external partners.

- Review/contribute to non-clinical QIAGEN documents and represent Clinical Affairs on multi-functional teams to ensure requirements are met for IVDR/FDA and ROW compliance.

- Update, review and contribute to SOPs and drive continuous improvement within the Clinical Affairs team including training other staff and representing QIAGEN in industry working groups.

Position Requirements

- Master’s degree (preferably PhD) in Life Sciences with a minimum 3 years’ employment experience with in vitro diagnostic devices and/or a clinical setting. Experience within oncology and/or companion diagnostics is preferred.

- Working knowledge of regulatory requirements and clinical practice guidelines e.g. FDA CFR, ICH GCP, ISO20916, ISO14971, ISO13485, MDR, IVDR, MedDev, MDCG, CLSI guidelines, CTS, GHFT/IMDRF.

- Good understanding of project management, proficiency in prioritizing work under tight and challenging deadlines within budget and in compliance with organizational SOPs and international regulations.

- Willingness and availability to travel nationally and internationally: 10-20%.

- Proficient in reading, analyzing and interpreting scientific and technical information, learning and understanding new therapeutic areas quickly and comprehensively.

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.

We offer:

- Possibility to develop in an international company
- Attractive pension
- Private Healthcare
- Private Dentalcare
- Gym membership contribution
- Access to an Employee Assistance Programme
- A range of retail discounts and offers

- Opportunity to join internal QIAGEN communities

- Enhanced maternity package

- Flexible working options
- Bonus/commission
- 25 days annual leave (potential to increase linked to service)

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.