Associate Director Clinical Pharmacology
Cambridge, MA, United States
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Associate Director Clinical Pharmacology
Open for hire at one of the following locations – Cambridge Erie Street. - Job ID: 7319
Join our team of pioneers!
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.
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 PD 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
Minimum 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
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.
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to find out more about what we do, the careers we offer ans 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!
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