Senior Scientist Clinical Pharmacology
Open for hire at one of the following locations – Cambridge Erie Street. - Job ID: 7318
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.
Senior Scientist Clinical Pharmacology
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 are critical for success.
Core responsibilities:
- 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
- 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
- Contribute to clinical pharmacology and pharmacometrics sections of regulatory documents (e.g. IB, regulatory briefing book, NDA/BLA)
Requirements:
- Ph.D. in pharmaceutics, pharmacokinetics, pharmacology, pharmacometrics, or related discipline, or Pharm.D. with relevant experience
- Minimum 3 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, Infectious diseases, and/or other relevant therapeutic areas
- Experience in translational research and/or pharmacometrics and its application to cancer, infectious disease, and/or other relevant therapeutic 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, Infectious diseases, and/or other relevant therapeutic areas
- Proficient in using Phoenix WinNonlin, R, NONMEM, MATLAB or other pharmacokinetic and modeling software
Benefits for you
BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.
Click here to find out more about what we do, the careers we offer and also the benefits we provide.
Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.
Have we kindled your pioneering spirit?
This vacancy is to be hired at one of the following locations – Cambridge Erie Street. Apply now for your preferred job and location through our careers site.
*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!