Sr. Research Investigator Clinical Pharmacology - Various Opportunities Available (R1554459-en-us)
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.
Senior Research Investigator Clinical Pharmacology – Various Opportunities Available
Here with Bristol Myers Squibb we have the following Research Investigator opportunities available within the Therapeutical Areas of Immunology, Fibrosis, Cardiovascular, Neuroscience and Oncology:
*Senior Research Investigator, Clinical Pharmacology and Pharmacometrics
*Senior Research Investigator, Pharmacometrics Modeling
Functional Area Description
The Clinical Pharmacology and Pharmacometrics (CP&P) teams at BMS are 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.
Our Teams Responsibilities….
1. Independently contribute to compound development across various development phases
2. Represent Clinical Pharmacology at asset teams at governance based on proficiency
3. Provide input to Phase 2/3 clinical study design and registrational strategy
4. Accountable for Clinical Pharmacology Plan
5. High proficiency in PK, PK/PD, and model informed drug development (MIDD) principles and analyses
6. Collaborate on cross-functional drug development teams, and regulatory submissions; serves as Clinical Pharmacology subject matter expert
1. With guidance, perform non-compartmental pharmacokinetic (PK) data analysis and reporting for regulatory submission using WinNonlin.
2. Under direction, provide protocol study design input and assist in the development of clinical study monitoring plans, site selection, and PK samples logistics.
3. Assist in the planning, implementing, interpreting and reporting of assigned Phase I to III PK and PK/PD studies.
4. Assist in the development of the statistical analysis plan.
5. Assist in the analysis and reporting population-pharmacokinetic and PK/PD data as necessary to describe pharmacokinetics in patient population.
6. With guidance, provide scientific oversight of CROs with respect to PK and PK/PD tasks.
7. Under direction, evaluate the relationship between exposure and pharmacodynamic (PD) properties for compounds from discovery to proof of activity to late stage Phase 3 drug development.
8. Under direction, provide PK and PK/PD strategies to compounds under drug development.
Advanced degree (Pharm.D. or Ph.D.) in pharmacokinetics/pharmacology/pharmacometrics or relevant life sciences
Ph.D. or Pharm.D. with minimum 2-years experience conducting and analyzing pharmacokinetic and pharmacodynamic studies in humans.
Key Competency Requirements
· Hands-on knowledge of pharmacokinetics and pharmacology concepts, and PK/PD data analyses, ie. population and exposure-response analyses.
· Hands-on knowledge of the use of clinical pharmacokinetics for designing first-in-human studies and providing PK strategies for late phase registration studies.
· Computer literate: familiarity with WinNonlinÔ or equivalent.
· Good knowledge of Microsoft Word, Excel, and PowerPoint.
· Good written and oral presentation skills.
· Ability to work in a matrix, project-oriented environment.
· Ability to organize and work simultaneously on multiple projects.
Working knowledge on clinical data base, PK/PD data compilation and manipulation with scripting softwares of NONMEM, SAS, Splus and/or R a plus
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.