Oncology Specialist, Clinical Pharmacology and Pharmacometrics

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, the individual will have the responsibility to lead the clinical pharmacology development of Oncology/Immuno-Oncology programs in clinical development and life cycle management. The individual will be responsible for the creation and design of the Clinical Pharmacology and Pharmacometrics plan in clinical development and life cycle management and contribute to the Clinical Pharmacology and Pharmacometrics aspects of exploratory clinical development plans. This individual will also contribute to the design, planning, execution and interpretation of Exploratory Clinical and Clinical Pharmacology studies. In addition, this individual will be expected to perform pharmacokinetic and pharmacodynamic modeling and simulation, and support and implement model-based drug development efforts throughout clinical development. This individual will contribute to the Clinical Pharmacology components of regulatory submissions and be responsible for responding to regulatory authority questions, in person and in written form. The individual may represent the department at the development matrix team level as the Clinical Pharmacology expert.

Requirements for the position include a Ph.D. in pharmacology or pharmacokinetics or related discipline, or a PharmD with a clinical pharmacology research fellowship. A minimum of 5 years experience gained through direct industry experience in Clinical Pharmacology/Pharmacokinetics is required. Demonstrated experience in preparing regulatory submissions, including NDA or BLA, as well as INDs. Experience responding to regulatory questions related to clinical pharmacology and pharmacokinetics/pharmacodynamics. Application and knowledge of current practices and issues in the following areas for multiple projects: clinical pharmacology, PK/PD, pharmacometrics, ADME, bioanalytical, biopharmaceutics, regulatory, non clinical metabolism, pharmacokinetics, pharmacology and toxicology. Direct experience designing, conducting and interpreting studies in population PK, PK PD correlations, modeling and simulation utilizing specialized software such as NONMEM, R/S-Plus, ADAPT, Gastroplus or Simcyp is highly desirable. Strong communication and project management skills required. Experience in biologics, and oncology, is a plus