The candidate will serve as Pharmacokinetic Project Lead on large pharmacokinetic projects and/or development programs. He/She will also provide senior reviews on pharmacokinetic projects and supervise a group of pharmacokineticists.
Responsibilities
- Review pharmacological deliverables and documents related to project activities
- Mentor pharmacokineticists and pharmacologists on concepts and applications of pharmacokinetics in drug development
- Provide oversight for strategic client relationships, and/or oversight for key client portfolios
- Assist with the scheduling of pharmacokinetic activities and the management of project schedules
- Develop and revise department SOPs and guidelines for the conduct, analysis and reporting of pharmacology and pharmacokinetic trials
Requirements
- Master's degree or equivalent in a scientific related discipline
- 3+ years of PK experience
- Ability to effectively mentor and motivate staff to promote teamwork in a multidisciplinary team setting
- Evidence of strong project management skills, as shown through the successful management of multiple projects
- Demonstrated ability to manage change and uncertainty to optimize positive outcomes
- Knowledgeable of regulatory guidelines related to pharmacology and pharmacokinetics areas of the drug development
- Demonstrated knowledge of the drug development process
- Strong theoretical background in pharmacokinetics with experience in pharmacokinetics and pharmacodynamics
- Understanding and demonstrated mastery of pharmacokinetics activities in drug development
- Able to apply pharmacokinetic theory and concepts using relevant software such as WinNonlin, NONMEM, SAS, S-Plus, R, or other pharmacokinetic packages
- Demonstrated initiative and motivation
- Excellent written and verbal communication skills
- Excellent organizational, communication, and problem-solving skills
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.