Associate Director* Clinical Pharmacology

Open for hire at one of the following locations –  Cambridge Erie Street, London, Mainz Goldgrube.
 

 

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.

 

Associate Director* 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 with cancer 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
• 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

 

Requirements

• Ph.D. in pharmaceutics, pharmacokinetics, pharmacology, pharmacometrics, or related discipline, or Pharm.D. or M.D. with relevant experience
• Min 5 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
• Proven ability to work independently and be self-motivated
• Excellent communication and presentation skills to efficiently relay information to project teams and other key stakeholders
• Ability to serve as a matrix leader or lead in a matrix environment
• 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

 

Have we kindled your pioneering spirit? 

 

This vacancy