Executive Director, Clinical Pharmacology Cambridge, US; London, United Kingdom; Mainz, Germany | full time | Job ID:9225 Lead the governing of the clinical pharmacology and pharmacometrics group including but not limited to technical oversight, resource planning, in-house/out-source strategy and cross-functional collaboration. Provide strategic direction for clinical pharmacology & pharmacometrics strategies from translational research, 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 Help 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 expertize and representation at global health authority meetings Education Ph.D. in pharmaceutics, pharmacokinetics, pharmacology, or related discipline with scientific and clinical background in Oncology and/or infectious diseases Experience Minimum 12 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 Special 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) 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. 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. How to apply: Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form. Please note:Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter. We are looking forward receiving your application.