Gesundheits- und Krankenpfleger (m/w/d) Ingelheim am Rhein Vollzeit/Teilzeit/Ausbildung JobImpulse Süd GmbH Mainz Gesundheits- und Krankenpfleger (m/w/d) Mainz am Rhein Ausbildung JobImpulse Süd GmbH Mainz (Senior) Director, Clinical Development Mainz Vollzeit BioNTech AG
Jetzt als Medical Expert* bei BioNTech AG durchstarten – Arbeitsort: Mainz
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BioNTech AG
Mainz
Stellenausschreibung
Open for hire at one of the following locations – Mainz K1, Cambridge Erie Street, Gaithersburg.
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.
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.
Medical Expert*
The Medical Expert Clinical Development is responsible for relevant aspects of clinical trial design, medical conduct of assigned clinical programs with BioNTech's inflammatory, autoimmune, neurodegenerative portfolio products, as well as medical review and related data cleaning. S/he will be responsible for data interpretation, communicating clinical findings/results through medical communications (e.g. presentations, publications, etc.) and interface/network with key opinion leaders in the field, organizing pre-IND meetings with key opinion leaders and internal regulatory experts to integrate critical feedback into clinical trial design. S/he contributes to the overall clinical trial design, timelines and key deliverables. S/he acts as a resource to internal and external clients on medical related issues.
Your main responsibilities are:
Your main responsibilities are:
- To function as one of the key members of the clinical study team and lead the clinical aspects of the study
- Integrate preclinical translational data sets and provide critical feedback to the team
- To develop/review/edit essential study documents such as protocols, medical monitoring plan, and medical data reviewing plan, case report forms, database specifications, statistical analysis plan, and clinical study reports including tables, listings and figures
- Contribute to the creation of study-level documents, including preparation of clinical sections of key regulatory documents, such as Investigator’s Brochures, briefing books, safety updates and submission dossiers. Contribute to the review and writing of clinical trial documents for study CSR activities, and publications (if applicable).
- Perform high quality clinical data review and identify clinical data insights through ongoing patient level review and trends analysis, thereby supporting for example Interim Analysis, Database and Post Lock activities and resolution of scientific & medical issues throughout the study lifecycle. For all these tasks, work in close collaboration and alignment with clinical development lead. Ensure all questions / issues requiring medical oversight are brought to the attention of the clinical development lead.
- Support pharmacovigilance activities (e.g. contributing to aggregate reports, patient narratives, attendance of pharmacovigilance monitoring meetings)
- To ensure that Clinical Development Standard Operating Procedures (SOPs) facilitate the development of effective clinical study protocols and are compliant with clinical, medical, and industry standards as well as GCP
- Support regulatory activities, like preparation and conduct of meetings with regulatory agencies.
- Produce training materials, share best practices and provide training to the broader clinical trial teams.
- Support preparation and (if applicable) participate in study level meetings for example Investigator Meetings, Data Monitoring meetings, and others.
What you have to offer.
- Advanced degree in life sciences/ healthcare (or clinically relevant degree) is required.
- Master’s, PharmD, MPharm, PhD, MBBS, BDS, MD strongly preferred.
- Several years of scientific, strategic and operational experience in planning, executing, reporting and/ or publishing clinical studies (pharmaceutical industry or academia)
- Good knowledge of procedures in global clinical studies in a pharmaceutical company or contract research organization (CRO), or comparable experience within academic research institution.
- Strong familiarization with Good Clinical Practice (GCP) and drug development processes, ideally Phase 1 – 3; ideally paired with experience in inflammatory disease, autoimmune, neurodegenerative portfolio products
- Knowledge of principles of clinical data collection and reporting; demonstrated ability to use systems and tools (e.g., EDC systems, Excel, etc.) for data collect
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