Associate Director, Clinical Pharmacology & Pharmacometrics

Princeton, NJ, United States
Sep 24, 2020
Required Education
Position Type
Full time
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

The Clinical Pharmacology and Pharmacometrics (CP&P) team at BMS is responsible for the pharmacology and pharmacometric support for all pipeline assets throughout the clinical development lifecycle. Composed of pharmacologists, pharmacometricians, and modelers, this group oversees the pharmacokinetic evaluation, pharmacometric exposure-response evaluation, quantitative systems pharmacology modeling, physiologically based pharmacokinetic modeling and model based meta-analysis of assets covering all platforms of therapies, including small molecules, traditional and complex biologics and next gen cell therapies. All therapeutic areas are supported. The CP&P team interacts with discovery and translational scientists, project leadership, early development, late development and commercial colleagues to optimize dosing, formulation, delivery and combination strategies to enable faster and more effective drug development informed by core scientific principals and data.

Scope of role:
  • Contribute to the development of compounds being developed across multiple therapeutic areas including but not limited to immunology, cardiovascular, virology, fibrosis, and oncology
  • Responsible for the creation of CP&P development plans that is aligned with compound strategy and execution of clinical pharmacology deliverables outlined by the development teams
  • Lead / Contribute to the design of clinical studies to characterize the pharmacokinetic, pharmacodynamic, and drug metabolism properties, as well as analyze, interpret and report data from such studies
  • Plan, execute, and report on model-based pharmacokinetic and exposure-response analyses of data from clinical studies
  • Represent the CP&P function on cross-functional drug development teams, contribute to regulatory submissions, and participate in interactions with health authorities
  • Lead and participate in departmental initiatives and represent CP&P on cross-functional initiatives / workstreams / taskforces
  • Work with Business Development teams and provide critical expertise to assess external acquisitions

The collegue will have / be able to
  • In-depth knowledge of current practices and issues in clinical pharmacology and pharmacometrics
  • Strong written and oral communication skills necessary to report on and deliver scientific presentations
  • Demonstrate the ability to work in a dynamic team oriented environment
  • Provide mentorship and guidance to staff and the CP&P function
  • Supervise a colleague in CP&P, as needed
  • Independently serve as the CP&P lead for one or more assets in the BMS drug development program

Degree Requirements

A PharmD or PhD in pharmaceutical sciences, pharmacology, biomedical engineering, or a related field.

Experience Requirements

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

Key Competency Requirements

Experience with the following software is highly desired: R, NONMEM, MONOLIX, and WinNonlin.

Travel Required

Local and international travel for conferences and regulatory meetings may be required depending on project needs up to 5-10% of the time

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.