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Study Director - ADME/Metabolite ID

Laboratory Corporation of America Holdings (Covance)

Madison, Wisconsin, United States

<h2≥Job Overview:</h2≥<p style="margin: 0px;"≥<span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"≥Improving lives and improving health is more than just a catchphrase. It's the mission that drives our 60,000+ enterprise team members across the globe. These exceptional people help solve drug development challenges and transform ideas into reality for patients. </span≥</p≥<p style="margin: 0in; margin-bottom: .0001pt;"≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥ </span≥</p≥<p style="margin: 0in; margin-bottom: .0001pt;"≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥With two state-of-the-art metabolism laboratories in Madison, Wisconsin, and Harrogate, UK, Covance has helped hundreds of pharmaceutical and biotechnology companies select compounds to progress into development. Covance by Labcorp provides a comprehensive range of ADME services to support drug discovery and development programs. We are looking to add a <strong≥Study Director  – ADME/Metabolite ID</strong≥ to our Drug Metabolism team in Madison, WI. </span≥</p≥<p style="margin: 0in; margin-bottom: .0001pt;"≥ </p≥<p style="margin: 0px;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥The Study Director is responsible for managing the design, conduct and reporting of studies to meet scientific, regulatory and client requirements.  The Study Director is the single point of study control and has overall responsibility for the scientific, technical and regulatory conduct of studies as well as for the interpretation, documentation and reporting of results. Close and regular liaison with the client is of primary importance.</span≥</p≥<p style="margin: 0px;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥The Study Director will demonstrate competence in directing studies of intermediate complexity in design and scope. The majority of studies undertaken will be non-GLP studies and routine & more complex GLP, GCP or GMP studies.  Will be responsible for:</span≥</p≥<ul≥<li style="margin-bottom: .0001pt;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥Study Execution </span≥</li≥<li style="margin-bottom: .0001pt;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥Science</span≥</li≥<li style="margin-bottom: .0001pt;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥Covance Business and People</span≥</li≥</ul≥<p style="margin: 0px;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥ </span≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥Looking for:</span≥</p≥<ul≥<li style="margin-left: .5in;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥PhD or equivalent preferred, or MSc/BSc degree in an appropriate scientific discipline with drug development experience.</span≥</li≥<li style="margin-left: .5in;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥Strong knowledge of the pharmacokinetic basis for drug absorption, distribution, and disposition.</span≥</li≥<li style="margin-left: .5in;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥High level of emphasis on Metabolite Identification experience as well as a range of ADME techniques/approaches in drug development.</span≥</li≥<li style="margin-left: .5in;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥Knowledge of requirements for working within a GLP, GCP and GMP (as appropriate) environment</span≥</li≥<li style="margin-left: .5in;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥Previous data interpretation and report writing experience</span≥</li≥<li style="margin-left: .5in;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥Working knowledge of software (eg, MS Word, Excel), specialty applications (eg, Analyst, Sigmaplot, WinNonlin Phoenix), and general IT skills</span≥</li≥<li style="margin-left: .5in;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥Experience in the drug development process, knowledge of regulatory requirements and the scientific techniques of Metabolism studies required. </span≥</li≥<li style="margin-left: .5in;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥Experience of client management and technical expertise in the relevant business line. </span≥</li≥<li style="margin-left: .5in;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥Fully competent in a feeder role for a study director with skills and competencies in the relevant study types.</span≥</li≥</ul≥<p style="margin: 0px;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥ </span≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥At Covance by Labcorp, you can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in an impressive history of company stability and growth. We’ve achieved these results by fostering a work environment that encourages, develops and leverages our team’s capabilities.</span≥</p≥<p style="margin: 0in; margin-bottom: .0001pt;"≥ </p≥<p style="margin: 0in; margin-bottom: .0001pt;"≥<span style="color: #ffffff;"≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥#LI-TC1</span≥</span≥</p≥<h2≥Education/Qualifications:</h2≥<ul≥<li style="margin-left: .5in;"≥<span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"≥PhD or equivalent preferred, or MSc/BSc degree in an appropriate scientific discipline with drug development experience.</span≥</li≥<li style="margin-left: .5in;"≥<span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"≥High level of emphasis on Metabolite Identification experience as well as a range of ADME techniques/approaches in drug development.</span≥</li≥<li style="margin-left: .5in;"≥<span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"≥Knowledge of requirements for working within a GLP, GCP and GMP (as appropriate) environment</span≥</li≥<li style="margin-left: .5in;"≥<span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"≥Previous data interpretation and report writing experience</span≥</li≥<li style="margin-left: .5in;"≥<span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"≥Working knowledge of software (eg, MS Word, Excel), specialty applications (eg, Analyst, Sigmaplot, WinNonlin Phoenix), and general IT skills</span≥</li≥</ul≥<h2≥Experience:</h2≥<ul≥<li style="margin-left: .5in;"≥<span style="font-size: 11.0pt;"≥Experience in the drug development process, knowledge of regulatory requirements and the scientific techniques of Metabolism studies required</span≥<span style="font-size: 11.0pt;"≥. </span≥</li≥<li style="margin-left: .5in;"≥<span style="font-size: 11.0pt;"≥Experience of client management and technical expertise in the relevant business line. </span≥</li≥<li style="margin-left: .5in;"≥<span style="font-size: 11.0pt;"≥Fully competent in a feeder role for a study director with skills and competencies in the relevant study types.</span≥</li≥</ul≥

Job posted: 2021-01-05

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