Senior PK Scientist

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

In this role, the individual will have the responsibility to review the pharmacokinetic section of a clinical protocol, ensure the pharmacokinetic components of the clinical case report form and the spec document match the protocol requirements and then create the pharmacokinetic database according the specifications dictated in the protocol and the expectations of departmental guidelines. This individual would also be responsible to review the pharmacokinetic concentration data for potential errors and coordinate the cleaning and tracking of PK metadata according to provided specifications. This individual would then transfer the cleaned data to the analysis program and conduct the expected non-compartmental pharmacokinetic analysis according to protocol and departmental specifications. From the analysis program, this individual would then create tables, listings, and figures according to the statistical analysis plan for the study and, when final, upload them to the proper document repository for access by the medical writer. This individual may also be responsible for reviewing pharmacokinetic components of the statistical analysis plan and authoring some components of the clinical study report. This individual will liaise with the Clinical Pharmacology Leads and protocol Study Directors in the Therapeutic Areas to understand the particular needs of the study and to keep them informed to the status of pharmacokinetic analysis. This individual will need to work with external partners for non-compartmental analyses that are performed by our external partners. The individual will provide the relevant reference documents, analysis expectations and timelines to the external partner and also QC their work. This individual may also assist in conducting, compiling, and summarizing literature searches to support elements of the protocol, clinical study report, or as other needs arise. This individual may also be asked to serve as a study director on certain outsourced studies and therefore must be able to understand all aspects of a clinical trial and be able to problem solve issues as they arise from protocol design to report completion.

Requirements for the position include a Masters in pharmacology/pharmacokinetics/pharmaceutical sciences or a related field with at least 2 years of pharmaceutical industry experience or equivalent. Knowledge of PK data flow process and experience with Phoenix WinNonlin is a plus. Experience working in a highly matrixed organization is desirable. Strong communication and multi-tasking skills are required. It is expected that the individual be highly self-motivated and likes to contribute toward problem solving.

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 the resources to pursue their goals, both at work and in their personal lives.

Company: Bristol-Myers Squibb

Req Number: R1521732_EN

Updated: 2020-02-25 00:00:00.000 UTC

Location: Princeton,New Jersey

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com