Associate Director / Director* Clinical Pharmacology
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Associate Director* Clinical Pharmacology
- 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
Knowledge, Skills & Abilities
- Ph.D. in pharmaceutics, pharmacokinetics, pharmacology, or related discipline with scientific and clinical background in Oncology and/or infectious diseases
- Minimum 5 to 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
Benefits for you
- Medical, Dental and Vision Insurance
- Life, AD&D, STD and LTD Insurance
- HSA & FSA Spending Accounts
- Health & Wellness, including free onsite gym access
- Adoption & Surrogacy Assistance
- Vacation and Unlimited Sick Time
- Holidays and Floating Holidays, including discretionary winter shutdown
- 401(K) Plan with Significant Company Match
- Tuition Reimbursement and Professional Development
- Commuting Assistance and free onsite parking
- Discounted Home and Auto Insurance
- Pet Insurance
To Apply, EEO and BioNTech Websites
*BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!
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