Senior Research Investigator, Clinical Pharmacology and Pharmacometrics

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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.

Responsibilities

• Supervise and/or mentor other CP&P scientists as appropriate

• Independently contributes to compound development across various development phases

• Represent ClinPharm at asset teams at governance based on proficiency

• Provides input to Phase 2/3 clinical study design and registrational strategy

• Accountable for Clinical Pharmacology Plan

• Leads design of clinical pharmacology studies and manages data analysis, interpretation, and reporting

• High proficiency in PK, PK/PD, and model informed drug development (MIDD) principles and analyses

• Collaborates on cross-functional drug development teams, and regulatory submissions; serves as Clinical Pharmacology subject matter expert

• Leads and participates in departmental initiatives and represent CP&P on cross-functional initiatives / workstreams / taskforces

• Participates in interactions with health authorities; serves as Clinical Pharmacology subject matter expert

• Provides critical expertise to Business Development teams to assess external acquisitions

Requirements

• Advanced Degree in related field (MS, Ph.D. or PharmD)

• For Sr. Research Investigator, with Ph.D. approximately 2+ years experience with demonstrated progression clinical pharmacology and Pharmacometrics

• For any level with Masters Degree and no Ph.D., 10 plus years Pharmaceutical experience with demonstrated progression clinical pharmacology and Pharmacometrics expertise in general drug development process

• Expertise in small molecule and/or biologic drug property characterization

• Demonstrated stakeholder management with strong influence/leadership

• Quantitative data analysis, POP PK/PD, and data visualization skills 

• Programming experience (e.g., NONMEN, R, WinNonlin, SAS, Splus etc.)

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