Covance

  • In Vivo Pharmacokinetics (PK) Team Lead – Metabolism

    Job Location(s) US-WI-Madison
    Job Number
    2018-18221
    Job Category
    Scientific Advanced Degree
    Position Type
    Full-Time
  • 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.

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