Associate Director* Molecular Pathology / CDx Development
Join our team of pioneers!
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 Pathology / CDx Development
BioNTech is seeking an "Associate Director* Molecular Pathology - CDx Development” to support our clinical development pipeline with analytical and diagnostic solutions. In this role you are part of the diagnostic team and will work together with cross functional teams to drive the implementation of assays from early clinical phases until marketing authorization.
Your main responsibilities are:
- Serve as Technical Lead for the development and implementation of global end-to-end Diagnostic (Dx/CDx) strategies in close collaboration with therapeutic program teams
- Ensure alignment of assay development activities and availability of the assay for the clinical development plans from early phases until marketing authorization
- Support the generation of clinical trial protocols with regards to biomarker-based definition of patient populations
- Manage relations with external diagnostic vendors and CROs and act as subject matter expert for evaluation of diagnostic partners and CROs
- Liaise with internal clinical development, translational biomarker experts as well as external academic project partners to generate insights from biomarker data
- Support the Global Regulatory Team on the global regulatory submissions and interactions global health authorities
What you have to offer:
- Scientific background in life sciences/oncology (PhD preferred) with a minimum of 7+ years relevant work experience in the in-vitro diagnostics industry or biotech/pharma
- Expert knowledge in tissue based or analytical platform methods, such as IHC, ISH, digital pathology, multiplex IHC
- Solid knowledge of relevant terminology and statistical procedures used in diagnostic development, biomarker research and clinical trials, especially in the field of oncology
- Robust understanding of the US and EU regulatory frameworks around in-vitro diagnostics and their implementation in clinical trials
- Team player with excellent communication and presentation skills. Fluent in written and spoken English (German is a plus)
- High level of initiative and ability to work independently
- Strong project management and organization skills with attention to detail
- Ability to navigate multiple projects in a complex and fast-paced environment
- Experience in commercial and/or medical aspects of companion diagnostics is a plus
Benefits for you:
- Flexible Working Time
- Mobile Office
- Work from EU Countries (up to 20 days per year)
- Company Pension Scheme
- Childcare
- Jobticket
- Company Bike
- Leave Account
- Fitness Courses
... and much more.
Have we kindled your pioneering spirit?
Then apply now for our location Mainz Goldgrube and simply send us your application documents using our online form.
If you have any further questions, our Talent Acquisition Team will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon to 4 pm).
Job-ID 7684 (please indicate for inquiries)
We look forward to your application!
*BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!
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