Associate Director, Pharmacometrician Clinical Pharmacology

Location
Princeton, NJ, United States
Posted
Sep 24, 2020
Ref
R1525378
Required Education
Masters Degree/MBA
Position Type
Full time
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Division

Research and Early Development / Clinical Pharmacology & Pharmacometrics /Pharmacometrics

Functional Area

Model-based integration of data to characterize the pharmacokinetics and exposure-response of therapeutic agents to: generate insights, bridge data-gaps, inform drug development decisions, and support health authority interactions.

Summary

Responsible for the development and implementation of the model-informed drug development (MIDD) strategy for drugs and other therapeutic agents in clinical development. PMx is a rapidly evolving discipline, and this individual will also be responsible for implementing and applying innovative PMx methodologies.

MIDD has emerged as a powerful complement to conventional drug development whereby pharmacometric (PMx: pharmacokinetic, exposure-response, and disease progression) models are developed with data from a variety of sources are utilized to inform drug development decisions and regulatory assessments. MIDD informs dose and regimen selection and hypotheses to be investigated in clinical studies; and supports regulatory assessments of the clinical pharmacology, and benefit-risk profile of a therapeutic agent by complementing data from clinical studies. Additionally, PMx analyses may also inform approval decisions, and in some cases be the primary basis for the approval.
  • Partners with CP&P lead to specify MIDD components of CP&P plan
  • Supports CP&P Lead in planning, executing, and reporting of exploratory PMx analyses in support of drug development decisions
  • Responsible for planning, executing, and reporting of formal PMx analyses included in CSRs, HA submissions, and responses to questions from HAs
  • Serves as MIDD SME, and supports CP&P lead in the development of therapeutic agents
  • Contributes to maintenance and refinement of PMx infrastructure
  • Leads or contributes to CP&P and cross-functional initiatives
  • Manages PMx analyses performed by vendors
  • Participates in interactions with health authorities as MIDD SME
  • Collaborates with internal and external SMEs to develop and enhance innovative MIDD methodology and capability
  • Provides mentorship to CP&P scientists on PMx and MIDD


Educational Requirements:

Advanced degree(s) in relevant field: MS, PhD, PharmD

Experience Requirements:
  • 5+ years' experience with demonstrated progression clinical pharmacology and Pharmacometrics
  • Quantitative data analysis: Data wrangling (merging and transforming data), visualization, advanced PPK and E-R
  • Programming: R, NONMEM, and Monolix (optional)
  • Experience with general drug development process
  • Experience with small molecule or biologic drug property characterization
  • Subject matter expertise demonstrated by peer-reviewed publications


Key Competency Requirements
  • 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
  • Demonstrated ability to work in a dynamic team-oriented environment


Travel Requirement

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

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.