Covance In Vivo Pharmacokinetics (PK) Team Lead – Metabolism in Madison, Wisconsin

Job Overview

We currently have an opening for a Study Director Team Lead within our In Vivo Pharmacokinetics (PK) group . This is a working role where the individual will be responsible for executing PK studies as Study Director, as well as leading a team of Study Directors working on PK studies. Additionally, the individual will support scientific client discussions to guide drug development and lead various service line initiatives.

Other responsibilities include:

  • Functions as a Senior Study Director to execute in vivo PK studies.

  • Demonstrates active involvement in HR responsibilities, including recruitment activities, performance evaluations, stack ranking and progressive discipline as required.

  • Participates in interviewing, hiring, and onboarding of junior and senior staff, as needed.

  • Conducts team member appraisals, performance documentation, regular 1-2-1 meetings, and justifies promotions or performance management.

  • Contributes to the establishment and implementation of staff development and operational goals.

  • Acts as coach and mentor for direct reports, as well as general metabolism staff.

  • Participates in and actively contributes to Metabolism Leadership Team meetings and initiatives.

  • Participates constructively in SD, team, project, and department meetings.

  • Drives service line initiatives and supports strategic goals through leadership and mentoring of team members.

  • Collaborates with and provides guidance for clients in the areas of in vivo PK and drug metabolism to meet project goals and aid in regulatory submissions.

  • Develops relationships and collaborates constructively with other Covance departments to facilitate study outlines and appropriate costing information.

  • Manages study issues and client concerns in cooperation with team members and other Covance groups; leads teams through corrective action and issue resolution processes.

  • Contributes to technical/scientific department policies and SOPs, evaluates existing departmental procedures and systems, and instigates and drives potential process and service line improvements.

  • Proactively and effectively communicates with internal and external clients.

  • Organizes and hosts client visits.

Education/Experience (Recommended)

  • PhD or equivalent, or MS/BSc degree in an appropriate scientific discipline, with research experience in drug development or similar field

  • Understanding of the drug development process and regulatory requirements

  • Experience in techniques/approaches of drug metabolism and pharmacokinetics

  • Experience in coaching, mentoring, and supervision

  • Experience of requirements for working within a GLP environment

  • Data interpretation and report writing experience

  • Working knowledge of software (e.g. Word, Excel), specialty applications (e.g. WinNonlin Phoenix), and general IT skills

Education/Qualifications

Recommended:

  • PhD or equivalent, or 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 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

Experience

  • 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.

Job Number 2018-18221

Job Category Scientific Advanced Degree

Position Type Full-Time

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