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.
- 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