CarterMackay Sr. Scientist (entry through mid level)
Title commensurate to experience and skills.
The successful candidate will participate and guide study, clinical development and project teams on Clinical Pharmacology /Pharmacokinetics. Conceptualize, design, and provide scientific oversight on clinical pharmacology studies/strategies working in close partnership with other project team members and functional areas to support clinical and product development programs.
Will be responsible for efficient, innovative, and timely clinical PK, PK/PD, and/or population PK study design, analysis, interpretation, and reporting for clinical and international regulatory submissions. Provide clinical pharmacology expertise/support in the preparation of regulatory submission (e.g. IB, IND, NDA). Experience with international regulatory bodies desired. Develops and implements new clinical pharmacology approaches to processes and clinical studies that impact development programs. Oversee scientific work/projects involving external contractors and/or vendors. Mentor and manage junior scientists (for higher Position Title).
Extensive knowledge of pharmacokinetic principles and expertise in its application software is required.
Demonstrate excellent written and verbal data presentation skills enabling contribution to internal/external multi-disciplinary teams, conference presentations and publications.
Knowledge, Experience and Skills:
PharmD or PhD with pharmacokinetic training, fellowship and/or postdoctoral experience and clinical pharmacology and/or clinical pharmacokinetic experience (Title commensurate to experience).
Training/experience in advanced pharmacokinetics (PK/PD and population PK modeling) clinical pharmacology, medicine and/or pharmacy with clinical research, drug development, and/or mathematical/statistical perspective is a strong plus.
Hands on experience in clinical trials management/study conduct and/or basic laboratory sciences are also desirable.
Must have established computer skills with detailed knowledge of PK programs and analysis software (e.g. WinNonlin, ADAPT II, Kinetica, WinNonmix, SAS, etc), along with experience with scientific graphing and analysis software (Sigma plot, GraphPad, Instat, etc). Population PK analysis experience is a plus.
Must have excellent written and verbal communication skills.
To apply for this job email your details to firstname.lastname@example.org