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- Princeton - NJ - US
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Bristol-Myers Squibb is a global biopharmaceutical company whose mission
is to discover, develop and deliver innovative medicines that help patients
prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around
the world, we are passionate about making an impact on the lives of
patients with serious disease. Empowered to apply our individual talents
and ideas so that we can learn and grow together. Driven to make a
difference, from innovative research to hands-on community support.
Bristol-Myers Squibb recognizes the importance of balance and flexibility
in our work environment. We offer a wide variety of competitive benefits,
services and programs that provide our employees the resources to pursue
their goals, both at work and in their personal lives.
*Position Description and Responsibilities*:
This individual will apply their Clinical Pharmacology and Drug
Development expertise to the development of small molecule and biologic
assets in Marketed Products that help patient prevail over serious disease
conditions including cardiovascular disease and virology. This person will
play a central role in the planning, design, execution, interpretation of
reporting healthy subject and patient studies conducted in early, full and
life cycle stages of development. You willl also provide broad
Pharmacometrics (PhMtrx) 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, you will
be responsible for generating modeling and simulation (M&S) plans and
conducting population pharmacokinetic and exposure-response analyses for
the assets. 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.
*Position Requirements*:
- The requirements for this position include Ph.D.in <http://ph.d.in/>
pharmacology or pharmaceutical sciences, or a PharmD with a clinical
pharmacology research fellowship.
- A minimum of 5 years experience gained through direct industry
experience in Clinical Pharmacology is required.
- The person that fills this role will have experience in the hands
on modeling and 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 prerequisite.
- 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).
- She or he will have knowledge and experience in the application of
current practices in the areas of clinical pharmacology,
pharmacokinetics,
pharmacodynamics, drug metabolism, bioanalysis, biopharmaceutics,
regulatory affairs, toxicology.
- 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.
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https://goo.gl/sfyXPN
