In this role, the individual will have the responsibility to lead the outsourced clinical pharmacology studies for various programs in early/full development and life cycle management by serving as the study director for these studies and to contribute to the design, planning, execution and interpretation of these studies.
This individual will liaise with the Clinical Pharmacology Leads in the Therapeutic Area to which they are assigned and with the Outsourcing Manager to understand the particular needs of the study selected for outsourcing.
The individual will also liaise with their clinical pharmacology counterparts of the outsourcing vendor in order to act as study director for the following types of clinical studies in healthy volunteers or patients:
drug-drug interaction; biopharmaceutics such as BA/BE and food effect; special population studies (renal, hepatic); and biocomparability studies, to name a few.
The individual will be responsible to guide, review, and comment on the study design, synopsis, protocol, conduct, results and clinical study report to ensure that they are aligned with the expectations of both the department and that of the BMS Clinical Pharmacology Lead.
The review and approval of the outsourcing vendors' pharmacokinetic plan and analyses is also expected.
The individual will manage, in conjunction with the outsourcing vendor and the BMS outsourcing manager, the clinical study process from protocol development to final study report, and to serve as a clinical pharmacology expert across the organization.
The individual will be expected to represent the department in meetings with the outsourcing vendors and to guide discussion in regards to compound, study requirements, and timelines.
The individual will also be responsible for creating best practices, guidance documents, and standards that make the role more effective and more uniform across study directors and across outsourcing vendors and to report to the outsourcing Oversight Management Committee on successes, issues, and/or needs for improvement, consistency, or best practices from a study director perspective.
Qualifications Requirements for the position include either a Ph.
in pharmacology/pharmacokinetics, or a PharmD with a clinical pharmacology research fellowship or equivalent, and a minimum of 5 years experience gained through direct industry experience in Clinical Pharmacology trials.
Experience in being a Study Director and contributing to the pharmacokinetic/pharmacodynamic aspects of clinical protocol design, writing, data interpretation, and/or review and reporting of results is preferred.
Experience in multiple therapeutic areas and experience with biologics is desirable.
Having experience developing clinical pharmacology plans and experience in preparing and responding to regulatory submissions is a plus.
Application and knowledge of current practices and issues in the following areas for multiple projects is desired:
clinical pharmacology, bioanalytical, biopharmaceutics, regulatory, non clinical metabolism and pharmacokinetics, pharmacology, and/or toxicology.
Knowledge of modeling and simulation techniques and related data interpretation on multiple projects is desirable.
Proven leadership skills working in a highly matrixed organization with a successful track record as a direct supervisor, mentor or developer of people.
Strong communication, project management, and negotiating skills required.
Bristol-Myers Squibb is an equal opportunity employer - M/F/Vet/DisabilityRequisition ID - 1501180

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