|Date Posted||March 3, 2021|
|Address||3301 Kinsman Blvd|
Our team is growing! We are looking to add a Senior In Vitro Study Director to our Drug Metabolism team in Madison, WI. 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.
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.
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 provides a comprehensive range of ADME services to support drug discovery and development programs.
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.
Come join a global leader in drug development.
Patients can't wait. Neither can we.
- PhD or equivalent with 5 years’ research experience in Metabolism in vitro drug development.
- Experience of a range of techniques/approaches relevant to the department and/or unique expertise for a specific scientific service
- Experience in coaching, mentoring, and supervision
- Experience of requirements for working within a GLP, GCP and GMP (as appropriate) environment
- Skilled data interpretation and report writing experience
- Working knowledge of software (eg, MS Word, Excel), specialty applications (eg, Analyst, Sigmaplot, WinNonLin Phoenix), and general IT skills
- 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.
- Expertise in at least one of the drug metabolism areas: in vitro CYP/UGT metabolism, CYP inhibition, CYP induction, transporter interactions, Caco-2 cells, drug-drug interactions, and plasma protein binding.