(Senior) Director, Clinical Development Mainz Vollzeit BioNTech AG Data Manager/ Data Engineer (m/f/d) Hamburg Vollzeit Fraunhofer-Gesellschaft Project Manager - EP Berlin Vollzeit Parexel
Starte als Director* Clinical Pharmacology bei BioNTech AG in Mainz – Dein Traumjob wartet
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BioNTech AG
Mainz
Stellenausschreibung
Become a member of the BioNTech Family!
As part of our team of more than 4,000 pioneers, you'll play a central role in solving some of the greatest scientific challenges of our time. In less than a year, we were able to develop our COVID-19 mRNA vaccine to the highest scientific and ethical standards – by far the fastest vaccine development in the history of medicine.
Our goal is 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. In doing so, we are guided by our three corporate values: innovation, passion and cohesion. If you also want to contribute to giving hope for a healthy future to many people, then we should get to know each other!
As part of our team of more than 4,000 pioneers, you'll play a central role in solving some of the greatest scientific challenges of our time. In less than a year, we were able to develop our COVID-19 mRNA vaccine to the highest scientific and ethical standards – by far the fastest vaccine development in the history of medicine.
Our goal is 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. In doing so, we are guided by our three corporate values: innovation, passion and cohesion. If you also want to contribute to giving hope for a healthy future to many people, then we should get to know each other!
A genuine interest and understanding of the science supporting the pipeline, an ability to work collaboratively in a multidisciplinary team setting, and a commitment to developing new treatments for patients with cancer are critical for success.
Core responsibilities:
- Supervise or leads the analysis, interpretation and reporting of clinical pharmacokinetic data
- Drives the necessary PKPD, exposure response and translational modeling and quantitative pharmacology activities to achieve mechanistic understanding of novel drug candidates, and support optimal dose and dosing schedule decisions
- Supervise or plans, designs, executes and reports program-specific clinical pharmacology studies (e.g. assessment of QT, food effect, ADME, DDI strategy, special populations, etc.) to support development and rapid registration of BioNTech products, by working cross-functionally with Translational Sciences Lead, Clinical Research, Biomarker operations specialists and other partners
- Partners with research leads for the design and data analysis/interpretation of pharmacokinetic (PK), toxicokinetic and pharmacodynamics (PD) aspects of preclinical studies
- Provides state of the art clinical pharmacology and pharmacometrics input in regulatory documents (e.g. IB, regulatory briefing book, NDA/BLA)
- Provides translational PK expertise and representation at global health authority meetings
- Recruit, guide and train junior staff
Requirements:
- Ph.D. in pharmaceutics, pharmacokinetics, pharmacology, pharmacometrics, or related discipline, or Pharm.D. or M.D. with relevant experience
- Minimum 8 years of experience in the biotechnology or pharmaceutical industry including a strong understanding of early and late drug development process from IND through NDA/BLA
- Direct experience in leading clinical pharmacology activities in drug development programs, from early exploratory studies to Phase 2/3 programs in Oncology and/or Infectious diseases.
- Experience in translational research and/or pharmacometrics and its application to cancer drug development, including PKPD, exposure response and translational modeling activities to support optimal dose and dosing schedule decisions
- Strong fundamental or research background with interest in understanding PK and PK/PD data in the context of complex biology
- Preferred scientific and clinical background in Oncology and/or Infectious diseases
- Proficient in using Phoenix WinNonlin, R, NONMEM, MATLAB or other pharmacokinetic and modeling software.
- Strong documentation and organizational skills, as well as proven ability to be self-motivated and able to work independently
- Excellent communication and presentation skills to efficiently relay information to project teams and other key stakeholders
- Understand cross-functional needs and ability to serve as a matrix leader or lead in a matrix environment
- Ability to effectively recruit, guide and train junior staff
- Proficiency in English (written and spoken)
Benefits for you.
BioNTech is committed to the wellbeing of our team members and offers a variety of benefits supporting our diverse employee base. We offer a competitive compensation package which will be determined by the contract type and selected candidate’s qualifications and experience.
Please click the link below to review a highlight of our benefits -
https://www.biontech.com/int/en/home/careers/working-at-biontech.html
https://www.biontech.com/int/en/home/careers/working-at-biontech.html
Have we kindled your pioneering spirit?
Then apply now for your preferred locations and simply send us your application documents using our
online form.
online form.
- BioNTech does not differentiate on the basis of gender, political opinion, religion or belief, nationality,
status or any other aspect of per
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