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