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This individual will apply their Clinical Pharmacology and Drug Development expertise to the development of small molecule and biologic assets in immunology that help patient prevail over serious autoimmune disease conditions. This person will play a central role in the planning, designing, executing, interpreting and reporting of healthy subject and patient studies conducted in early, full and life cycle stages of development. This individual will also provide broad pharmacometrics strategic leadership to early and late stage assets. Provide critical input on the design and execution of Clinical Pharmacology plans and be able to create a robust human Clinical Pharmacology profile by integrating results from a broad spectrum of non-clinical, clinical and model-based assessments. In addition, this individual will be responsible for generating modeling and simulation plans, conducting population pharmacokinetic and exposure-response analyses for the assets, and managing analyses conducted by pharmacometrics vendors ensuring timely delivery of deliverables. This individual will serve as the Clinical Pharmacology subject matter expert on cross functional asset teams and provide his/her functional expertise during health authority interactions and regulatory submissions.
Ph.D. in pharmaceutical sciences, biomedical engineering, or a PharmD with a clinical pharmacology research fellowship.
A minimum of 5 years of experience gained through direct industry experience in Clinical Pharmacology is required.
Hands on modeling and experience of application of quantitative clinical pharmacology including, pharmacometrics and other model-based approaches to guide drug development.
Extensive knowledge of the pharmacokinetic and pharmacodynamic aspects of clinical protocol design, writing, data interpretation and reporting is a required.
Experience of working on the development of both small molecules and biologics is highly desirable.
The successful applicant should have experience in providing input on clinical pharmacology plans and the preparation of regulatory submissions (e.g. INDs, NDAs, BLAs and/or significant sNDAs/sBLAs).
Strong oral and written communication skills necessary to formally present and report information internally and externally is required.
The ability to work in a dynamic team oriented environment is essential.
Bristol Myers Squibb