Research Investigator/Sr Research Investigator, Pharmacometrics

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Summary/Scope

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

Skills/Knowledge Required

• For Sr. Research Investigator we require Ph.D or PharmD. in relevant field with 2+ years experience hands on Pharmacometrics experience in industry, or hands on Post Doctoral Fellowship in Pharmacometrics activities may be considered. OR Masters Degree with 7 years Pharmacometrics experience required.

• For Research Investigator level we require Ph.D.or PharmD in relevant field with 0-2 years Pharmacometrics experience in industry or hands on Ph.D Program OR Masters Degree with 5 years Pharmacometrics experience required.

• 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

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If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

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