Senior Research Investigator, Pharmacometrics

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Model-based integration of data to generate insights, bridge data-gaps,
inform drug development decisions, and support health authority
interactions. Pharmacometrics (PMx) applications including population
pharmacokinetics and exposure-response.

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 Clinical
Pharmacology (CP) Lead for the asset.

Model Informed Drug Development (MIDD) has emerged as a powerful complement to conventional drug development whereby PMx models are developed with data from a variety of sources are utilized to inform drug development decisions and regulatory assessments. MBMA approaches provide a complementary quantitative view of the competitor/comparator space. Generally, 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.  

Responsibilities

Partners with CP lead to specify MIDD components of PMx plan, with
some supervision
• Supports CP Lead in planning, executing, and reporting of exploratory
PMx analyses in support of drug development decisions, with some
supervision
• Responsible for planning, executing, and reporting of formal PMx
analyses included in CSRs, HA submissions, and responses to
questions from HAs, with some supervision
• Serves as MIDD SME, and supports CP lead in the development of
therapeutic agents, with some supervision
• Contributes to maintenance and refinement of PMx infrastructure, with
some supervision
• Contributes to QPDA and cross-functional initiatives
• Manages PMx analyses performed by vendors, with some supervision
• Participates in interactions with health authorities as MIDD SME, with some supervision
• Collaborates with internal and external SMEs to develop and enhance
MIDD methodology and capability, with some supervision

Requirements:

Advanced Degree in relevant field (Ph.D., PharmD, MS)

For Ph.D. or PharmD level, 2 years’ experience with demonstrated progression in PMx and CP knowledge

For Master’s level 5 years’ experience with demonstrated progression in PMx and CP knowledge
• Basic quantitative data analysis, Data wrangling (merging and
transforming data), visualization, advanced PPK and E-R
• Programming: R, NONMEM, and Monolix (optional)
• General knowledge of drug development process

Key Competency Requirements
• Knowledge of current practices and issues in PMx and CP
• 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 Required Local and international travel for conferences and regulatory meeting may be required depending on project needs up to 5-10% of the time

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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

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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