Study Director - ADME/Metabolite ID
Madison, WI 
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Posted 2 days ago
Job Description
Job Overview:

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.

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 Study Director - ADME/Metabolite ID 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. Will be responsible for:

  • Study Execution
  • Science
  • Covance Business and People

Looking for:

  • PhD or equivalent preferred, or MSc/BSc degree in an appropriate scientific discipline with drug development experience.
  • Strong knowledge of the pharmacokinetic basis for drug absorption, distribution, and disposition.
  • High level of emphasis on Metabolite Identification experience as well as a range of ADME techniques/approaches in drug development.
  • Knowledge of requirements for working within a GLP, GCP and GMP (as appropriate) environment
  • Previous 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
  • Experience in the drug development process, knowledge of regulatory requirements and the scientific techniques of Metabolism studies required.
  • Experience of client management and technical expertise in the relevant business line.
  • Fully competent in a feeder role for a study director with skills and competencies in the relevant study types.

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.

#LI-TC1

Education/Qualifications:
  • PhD or equivalent preferred, or MSc/BSc degree in an appropriate scientific discipline with drug development experience.
  • High level of emphasis on Metabolite Identification experience as well as a range of ADME techniques/approaches in drug development.
  • Knowledge of requirements for working within a GLP, GCP and GMP (as appropriate) environment
  • Previous 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
Experience:
  • Experience in the drug development process, knowledge of regulatory requirements and the scientific techniques of Metabolism studies required.
  • Experience of client management and technical expertise in the relevant business line.
  • Fully competent in a feeder role for a study director with skills and competencies in the relevant study types.

Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran). Your confidentiality and privacy are important to us.

 

Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Experience
Open
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