Director* Clinical Pharmacology
- Cambridge, Massachusetts
- Research, development, teaching
- Published: 15.02.2022
Become a member of the BioNTech Family!
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
- Performs analysis, interpretation and reporting of clinical pharmacokinetic data
- Executes 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 cross functional experts 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 input in regulatory documents (CSP related PK endpoints, SoA, IND, final study reports, NDA)
- Provides translational PK expertize and representation at global health authority meetings
What you have to offer.
- Ph.D. in pharmaceutics, pharmacokinetics, pharmacology, or related discipline with scientific and clinical background in Oncology and/or infectious diseases
- Previous experience in the biotechnology or pharmaceutical industry including a good understanding of early and late drug development process from IND through NDA/BLA
- Direct experience in leading clinical pharmacology activities in drug development programs
- Experience 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
- Strong documentation and organizational skills
- Proven ability to work independently and be self-motivated
- Excellent communication and presentation skills to efficiently relay information to project teams and other key stakeholders
- Previous experience working in a matrix environment is preferred
- Proficiency in English (written and spoken)
Benefits for you.
- Medical, Dental and Vision Insurance
- Life, AD&D, STD and LTD Insurance
- HRA & 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
- And more!
Have we kindled your pioneering spirit?
If you have any further questions, our Talent Acquisition Team will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon to 4 pm).
Job-ID 6147 (please indicate for inquiries)
We look forward to your application!
*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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