Research Investigator, Clinical Pharmacology and Pharmacometrics, Immunology Fibrosis CV (R1545943-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.
Job Description – Research Investigator, Clinical Pharmacology and Pharmacokinetics
Functional Area Description
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.
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 or relevant
Ph.D. or Pharm.D. with 0 to 2-years experience conducting and analyzing pharmacokinetic
and pharmacodynamic studies in humans.
Key Competency Requirements
Basic knowledge of pharmacokinetics and pharmacology concepts, and PK/PD data analyses, ie. population and exposure-response analyses.
Basic 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.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
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