Biologe (f/m/x)

Become a member of the BioNTech Family!

As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age.

Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards - writing medical history.

We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases.

While doing so, we are guided by our three company values : united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.

Associate Director* Molecular Diagnostics

As part of the Molecular Diagnostics team, you will serve as cross-functional Lead for in vitro diagnostic (IVD) device co-development projects to support and enable BioNTech's clinical programs.

As an IVD expert you will be at the forefront of our clinical development programs. Collaborating closely with our team of experts, including clinicians, regulatory specialists, and program managers as well as diagnostic partners.

You will play a vital role in the planning, execution, and management of clinical trials for medical devices and IVDs.

Your main responsibilities are :

Independently coordinate IVD and / or companion diagnostics (CDx) Co-development projects as SME. Contribute to design input, defining performance characteristics and validation requirements for trial-specific intended purposes of tests in our clinical programs.

Monitoring of development activities and development plans of external diagnostic partners and alignment with BNT's clinical timelines

• Review partnership contracts to identify critical development and regulatory submission milestones, risks, and opportunities
• Critically review development documentation e.g., presentations on analytical performance data, summary of verification plans and reports, clinical performance study plans / reports, performance evaluation reports.

Confirming milestone achievement as well as approval of milestones and pass-through costs. Support the internal and diagnostic partner’s Regulatory Team on global regulatory submissions and interactions with health authorities

Contribute to clinical trial design with involvement of diagnostic biomarker analyses. Contribute and review clinical trial protocols, informed consent forms.

Support clinical operations and clinical development teams to answer queries from competent authorities or ethical committees regarding medical devices.

Contribute to preparation of meetings with FDA, EMA or other competent authorities with diagnostic partner and / or clinical

Provide advice to and support other Departments / third parties regarding technical and regulatory aspects of diagnostic testing and medical devices.

Select diagnostic partner / vendor and participate in contracting for IVD device development.

What you have to offer :

• Scientific background in life sciences / oncology (PhD preferred) with a minimum of 7+ years relevant work experience in the IVD industry or biotech / pharma.
• Robust understanding of IVD medical device regulatory requirements and submission processes for U.S. and E.U. (Rest of World knowledge is a plus)
• Strategic experience related to the development and implementation of pre-clinical and clinical strategies for clinical IVD products and assuring compliance to all applicable regulations
• Experience in evaluating and selecting appropriate vendors / diagnostic partners, defining customer and product requirements, and establishing the intended use of Dx products
• Experience in planning, overseeing, and leading projects with internal and external partners based on a broad spectrum of molecular biology methods for different prognostic or predictive biomarker analyses
• Extensive knowledge of the US and EU regulatory frameworks around IVD devices and their implementation in clinical trials
• Team player with excellent communication and presentation skills
• Fluent in written and spoken English (German is advantageous)
• Ability to navigate multiple projects in a complex and fast-paced environment

Benefits for you :

• Flexible Working Time
• Mobile Office
• Work from EU Countries
• Company Pension Scheme
• Childcare
• Jobticket
• Company Bike
• Leave Account
• Fitness Courses
• and much more.
Vor 30+ Tagen