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.
Responsible for the development and implementation of the model-informed drug development (MIDD) plan for drugs and other therapeutic agents in clinical development, in partnership with the CP&P Lead for the asset.
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.
**Responsibilities will include, but are not limited to, the following:**
+ Partners with CP&P Lead to specify MIDD components of CP&P plan, with supervision
+ Supports CP&P Lead in planning, executing, and reporting of exploratory PMx analyses in support of drug development decisions, with supervision
+ Responsible for planning, executing, and reporting on formal PMx analyses included in CSRs, HA submissions, and responses to questions from HAs, with supervision
+ Serves as MIDD SME, and supports CP&P lead in the development of therapeutic agents, with supervision
+ Contributes to maintenance and refinement of PMx infrastructure, with supervision
+ Contributes to CP&P initiatives
+ Advanced degree(s) in relevant field: MS, PhD, PharmD, with 0-2 years experience.
+ Basic quantitative data analysis, Data wrangling (merging and transforming data), visualization, basic PPK and E-R are all highly desired
+ Programming experience is highly desired (e.g., R and NLME software such as NONMEM or Monolix)
+ 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
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.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
**Company:** Bristol Myers Squibb
**Req Number:** R1535574
**Updated:** 2021-09-20 13:03:29.920 UTC
**Location:** Princeton,New Jersey
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.