Job Title: Manager/Senior Manager, Preclinical Operation
Job Number: 29445
Location: Raleigh, NC
Summary: As a preclinical operation manager/sr. manager, s/he will collaborate closely with research and development colleagues (DMPK, Toxicology, Translational Sciences, Clinical Pharmacology, Clinical Operation, and Clinical Research), as well as nonclinical and clinical CROs to oversight over all aspects of preclinical operations, including but not limit to organizing and tracking of nonclinical studies, bioanalytical operation and sample management, managing resources and timelines. Relevant scientific and technical experiences with toxicology, DMPK and bioanalysis is preferred.
Work closely with research and development colleagues (DMPK, Toxicology, Translational Sciences, Clinical Pharmacology, Clinical Operation, and Clinical Research) to understand, plan, place and manage DMPK, Bioanalytical, and Toxicology studies for discovery and development programs. Liaise with nonclinical and clinical CROs for effective planning and operational conduct of the studies, including the budgeting/financial process (e.g. SOW, PO, invoices), study conduct (e.g. toxicology study tracking, bioanalytical sample management), and technical execution (e.g. data transfer and management, study report and data QC) as needed. Participate in negotiating and managing contracts with CROs for discovery and development programs. With a technical and scientific background in DMPK, bioanalysis, or toxicology, s/he will also take on additional responsibilities as needed in supporting various preclinical activities.
Minimum of BS, preferably a Master degree in a life science or related fields. 2+ years of hands on nonclinical technical background, e.g. as a DMPK or bioanalytical scientist, a toxicology or pathology technician with experience in supporting drug discovery and development programs. 2+ years of client manager experience at a full service nonclinical CRO; proficiency in interfacing between clients and the CRO organization for timely study planning and conduct. Alternately, 2+ years of experience as a nonclinical study manager in the biotech/pharmaceutical industry. Familiarity and working knowledge of a broad range of nonclinical studies relevant to drug development (Toxicology, DMPK, Bioanalytical, Biology, Pharmacology), and Clinical Pharmacology. Ability to work in a matrix environment across nonclinical disciplines (Toxicology, DMPK, Biology, Translational Sciences, and Pharmacology) as well as Clinical Pharmacology to enable operational support for the portfolio. Strong written, verbal, and interpersonal communications skills including ability to communicate scientific information clearly and effectively. Demonstrated ability to work effectively with cross-functional groups and external partners/CROs in a matrix team environment. The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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