Director* Clinical Pharmacology
Open for hire at one of the following locations – Cambridge Erie Street, Gaithersburg, London, Mainz Goldgrube. - Job ID: 6036
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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
Core responsibilities:
- As Director Pharmacology & Pharmacometrics team lead, leads a team of clinical pharmacologists and pharmacometricians and is responsible for developing and executing, in the assigned portfolio, clinical pharmacology & pharmacometrics strategies from exploratory early studies to phase 2/3 studies with registration intend, in alignment with clinical development objectives.
- Drives at the portfolio level 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
- Drives at the portfolio level 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 the translational sciences team lead, clinical research portfolio leads, biomarker operations team lead 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
- Ensures state of the art clinical pharmacology input in regulatory documents (CSP related PK endpoints, SoA, IND, final study reports, NDA)
- Ensures translational PK, PK/PD and pharmacometrics expertise and representation at global health authority meetings
Requirements:
- Ph.D. in pharmaceutics, pharmacokinetics, pharmacology, or related discipline with scientific and clinical background in oncology and/or infectious diseases
- Minimum 10 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
- Expert in translational research and its application to cancer drug development, including PKPD, exposure response and translational modeling activities to support optimal dose and dosing schedule decisions
- Strong research background and interest in understanding PK data in the context of complex biology
- Established history of leadership and organizational skills
- Strategic influencing and communication skills with experience in stakeholder management at leadership team level
- High level of comfort/success working in a matrix environment (global/cross-functional), including contributing to establishing clarity and structures and driving state of the art collaborations with external academic and industry partners
- A genuine interest and understanding of the science supporting the development programs. Confident to discuss and present scientific and mechanistic aspects of drug development
- Leadership skills which drive performance and motivate others
- 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.
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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, Gaithersburg, London, Mainz Goldgrube. 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!