Director* Clinical Pharmacology

Open for hire at one of the following locations –  Cambridge Erie Street, Gaithersburg, London, Mainz Goldgrube. - Job ID: 6037 

 

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.

 

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:

• 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 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.

 

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