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Associate Director - Clinical Pharmacology & Pharmacometrics / Oncology

Employer
Bristol Myers Squibb Company
Location
Princeton, NJ, United States
Start date
Apr 23, 2019

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Job Details

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.

In this role, you will be responsible for representing the Clinical Pharmacology & Pharmacometrics (CP&P) function on oncology/immuno-oncology drug development teams, and will be responsible for the formulation and execution of CP&P plans to support the clinical development and life cycle management of compounds in development. This responsibility will include serving as the CP&P lead in the design, planning, and execution of clinical pharmacology studies, and the interpretation and reporting of study results. You will also be expected to manage and perform pharmacometric analyses to inform the drug development; and to contribute to the clinical pharmacology components of regulatory submissions and responses to questions from health authorities.
  • Ph.D.in pharmacology, pharmaceutical sciences, chemical/biomedical engineering, or a related discipline.
  • 5+ years of experience in clinical pharmacology and pharmacometrics, including experience in characterizing the pharmacokinetic and pharmacodynamic (biomarker/safety/efficacy) properties of small molecule and biologics drugs.
  • Experience in designing clinical pharmacology aspects of clinical protocols, supporting execution of clinical studies, and in contributing to clinical study reports
  • Experience in preparation of regulatory submissions (such as IND, CTA, PIP/PSP, NDA, BLA, MAA), and responding to questions from health authorities
  • Knowledge of current practices in the areas of clinical pharmacology, pharmacometrics, drug metabolism, bioanalysis, biopharmaceutics, toxicology, and regulatory affairs,
  • Hands-on experience NONMEM and R, or related software
  • Strong oral and written communication skills, and ability to work in a dynamic team oriented environment

Company

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.

At Bristol Myers Squibb, we believe in the power of science to address some of the most challenging diseases of our time. Our focus on these unmet needs comes during a remarkable time, when unprecedented scientific breakthroughs are advancing the treatment of disease as never before in human history.

We work every day to transform patients’ lives through science. Each day, our employees around the world work together for patients – they are at the center of everything we do. They inspire us. They are the reason we come to work each day.

We combine the agility of a biotech with the reach and resources of an established pharmaceutical company to create a global leading biopharma company powered by talented individuals who drive scientific innovation.

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Company info
Website
Phone
+1-800-332-2056
Location
430 E. 29th St
14th Floor
New York
New York
10016
United States

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