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InVitro Senior Study Director Team Leader

Company: Covance
Location: Green Bay
Posted on: December 4, 2019

Job Description:

Recruiter Covance Location Green Bay, Wisconsin (US) Salary Competitive Posted 25 Nov 2019 Closes 23 Dec 2019 Ref COVAGLOBAL38430EXTERNAL Discipline Clinical, Project Management, Research, Life Sciences, Metabolism Result Type Jobs Position Type Permanent Hours Full Time You need to sign in or create an account to save Job Overview:This is an exciting time to join our growing Metabolism departmentas an In Vitro Senior Study Director Team Leader. We are looking for someone with the drive to take on the responsibilities of leading a staff responsible for the technical and/or scientific conduct of the in vitro metabolism studies that generate high quality scientific results in support of the development of life-saving ************** this senior leadership role, you will be responsible for:Study ExecutionEnsures that studies are performed to the required scientific, regulatory and client standards, in accordance with the study protocol and Covance standard operating procedures.Understands Study Director (SD), Principle Investigator (PI), and Contributing Scientist (CS) responsibilities and the organization of multi-site studies. Consults with SD/PI/CS colleagues to determine project requirements and plan accordingly, reviews protocol changes and communicates to client and management as necessary.Institute sound project management practices to maintain profitability and support growth of the organization, offering creative & innovative solutions to drive commercial and customer strategiesApplies in depth knowledge of current GLP, GCP, GMP and regulatory guidelines relevant to study conduct. Directs a wide range of complex studies and coordinates internal and external programs of work.ScienceResponsible for validating regulatory led advances in their field and identification and recommendation on new service lines, strategic direction & differentiationAct as a Metabolism in vitro Subject Matter Expert (SME) in support of program management functions and consultancy services, and is key contact for other departments. Actively participates in client meetings (externally and internally) to promote services to support GCOProvides internal technical or scientific guidance in area of expertise eg in vitro, regulatory, facility design, technical training or laboratory animal management.Leads internal and external scientific events and represents Company as subject matter expert (SME).Covance Business & PeopleWorks with the Global Lead to identify areas in which the department will concentrate its research efforts. Independently implements the necessary strategies to affect the operational plan including capital investment to meet business growth objectives.Drives process toward meeting departmental goals and objectives and takes any required corrective action. Develops scientific training programs and initiatives to assist in the development of metabolism staff. Acts as a mentor to others.What were looking for in you:PhD or equivalent MSc/BSc degree in an appropriate scientific discipline with experience in performing research in a relevant fieldExperience in coaching, mentoring and supervisionWorking knowledge of software (eg, MS Word, Excel), specialty applications (e.g., Analyst, Sigmaplot, WinNonLin Phoenix), and general IT skillsRecognized scientific leadership, a track record in client management & demonstrated expertise within the industry are pre-requisites for this role.Expert understanding of the drug development process, regulatory requirements and the scientific techniques of Metabolism studies required.Expert understanding of Metabolism in vitro assays and techniques with the ability to effectively interpret and communicate results.Extensive experience of client management and technical expertise in the relevant business line, to prepare complex programmes involving DMPKFully competent in a Study Director role or equivalent and have developed skills and competencies in the relevant study types.Skilled in delivering presentations and leading meetings.Skilled in time management, planning, strategy and budgeting.There is no better time to join us!Education/Qualifications:PhD or equivalent, or MSc/BSc degree in an appropriate scientific discipline, with research experience in drug development or similar field Experience of a range of techniques/approaches relevant to the department and/or unique expertise for a specific scientific serviceExperience in coaching, mentoring and supervisionExperience of requirements for working within a GLP, GCP and GMP (as appropriate) environmentSkilled data interpretation and report writing experienceWorking knowledge of software (eg, MS Word, Excel), specialty applications (e.g., Analyst, Sigmaplot, WinNonLin Phoenix), and general IT skillsExperience:Full understanding of the drug development process, regulatory requirements and the scientific techniques of Metabolism studies required. Extensive experience of client management and technical expertise in the relevant business line. Fully competent in a Study Director role or equivalent and have developed skills and competencies in the relevant study types. Sign up for job alertsGet new jobs for this search by email Email jobs

Keywords: Covance, Green Bay , InVitro Senior Study Director Team Leader, Hospitality & Tourism , Green Bay, Wisconsin

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