Director* Trial Transparency
- Manager First Level
- Research, development, teaching
Become a member of the BioNTech Family!
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.
Director* Trial Transparency
You will be part of an international team that supports the development of novel immunotherapeutic agents from discovery to post-marketing approval life cycle management.
The position holder will work on site at our headquarters in Mainz near Frankfurt (Germany), but some home office work will also be possible.
- Support (hands on) and/or coordinate timely completion of tasks related to the protection and justification of CCI, as well as protected personal data (PPD), in data/documents before release in response to FOI requests. Advise the BioNTech Board on the requirements, risks, and the necessary mitigations related to compliance with FOI requirements
- Support and/or coordinate timely completion of tasks related to the trial registration and results reporting in relevant web-based registries (e.g., clinicaltrials.gov, EudraCT)
- Building upon state of the art knowledge of accepted justifications and relevant court decisions, justify CCI in data/documents. Where required, respond to authority questions and feedback related to these justifications
- Foster company awareness of the risks linked to CCI, how to identify and justify CCI, and how to minimize the risks linked to CCI in documents/data
- Establish and maintain tools/processes for the identification and tracking of CCI in data/documents, to enable faster and reliable identification of CCI at the time of FOI requests for sharing
- Manage a team of suitably trained staff performing trial registration and results reporting in relevant web-based registries, performing review for CCI and PPD, tracking of CCI, and protecting CCI and PPD
What you have to offer.
- A relevant life science university degree, ideally M.D. or Pharm. D. or a Ph.D.
- Ideally background knowledge in immunology or oncology
- >5 years hands-on experience in a similar FOI/Trial Transparency role in the pharmaceutical or biotech industry
- Prior hands on experience in trial registration and results reporting in relevant web-based registries (e.g., clinicaltrials.gov, EudraCT)
- A ‘can do’ attitude with the ability to work according to tight timelines and to prioritize workload, whilst concentrating on delivery and adding value
- Prior experience demonstrating the ability to independently identify and solve problems and/or to establish/improve role relevant tools and processes
- Excellent organizational, time management, and interpersonal skills
- Strong interpersonal skills with the ability to influence without authority, motivate with enthusiasm and develop productive working relationships with key stakeholders
- Profound knowledge of FOI/trial transparency requirements
- Expert MS Office applications (Word, PowerPoint, Excel) skills
- Proficiency in English (written and spoken)
Benefits for you.
- Company Pension Scheme
- Company Bike
- Leave Account
- Fitness Courses
- Flexible Hours
- Generous Holiday Allowance
- Mobile Office
- Special Vacation
Have we kindled your pioneering spirit?
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 5850 (please indicate for inquiries)
We look forward to your application!
*BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!
BioNTech - As unique as you