About the Role:
Leads internal and external clinical pharmacokinetic (PK) and pharmacodynamics (PD) modeling and simulation activities. Oversees the design, conduct, and reporting of modeling and simulation analyses conducted by external Contract Research Organizations (CROs) in support of product registration of a small molecule therapeutic. Conducts internal PK/PD modelling and simulation in support of early stage programs or internal decision-making of late-stage programs. Will present modelling and simulation analyses to internal project teams and may present to external colleagues or regulatory agencies. Will contribute to the preparation of an overall Clinical Pharmacology/Pharmacometrics Development Plan for NBI development compounds.
Your Contributions (include, but are not limited to):
- Leads internal and external clinical PK and/or PK/PD modeling and simulation activities.
- Develops novel and creative solutions to overcome issues/study obstacles.
- Oversees the design, conduct, and reporting of modeling and simulation analyses conducted by external Contract Research Organizations (CROs) in support of regulatory submissions.
- Provides expert consultation for PK/PD data from Phase 1/2 studies and application of quantitative decision-making to assist in the elucidation of dose- and exposure-response relationships to optimize subsequent clinical development.
- Significantly contribute to the PK analysis, interpretation and reporting of PK results from clinical trials.
- Expert resource for Nonclinical colleagues to lead/drive PK/PD modeling of discovery and development compounds in nonclinical test systems.
- Development and implementation of industry leading, long-term Modeling and Simulation strategy for the organization.
- Reports on results through written contributions to Clinical Study Reports.
- Contributes to standards and best scientific practices development, maintenance and communication.
- May lead publication of ﬁndings or is a major contributor to these processes
- Performs other duties as assigned.
- MS in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Chemistry, Biochemistry, or related field with a specific focus on PK and PK/PD modeling and simulation and 13+ years of Pharmaceutical/Biotech industry experience in conduct and/or oversight of late-stage Modeling and Simulation activities, including conduct or oversight of small molecule population pharmacokinetic analyses. Experience in the preparation of components of the Clinical Pharmacology sections of Regulatory submissions for IND- and NDA-stage projects, OR
- PharmD or PhD or equivalent preferred and 7+ years of relevant experience; may include postdoc experience
- Expert knowledge in conduct and/or oversight of late-stage Modeling and Simulation activities, including conduct or oversight of small molecule population pharmacokinetic analyses
- In depth knowledge of all stages of clinical drug development, including the preparation of components of the Clinical Pharmacology sections of Regulatory submissions for IND- and NDA-stage projects
- Demonstrated ability to independently design novel/highly complex studies to characterize PK/PD relationships of clinical development compounds
- Competent in the use of PK and PK/PD Modeling software tools including WinNonlin, NONMEM, S-Plus and SAS
- Significant expertise in preparing NDA/MAA summaries of population pharmacokinetic PK/PD analyses would be highly beneficial
- Applies understanding of the team's place in the larger organization, and discusses changes, progress, and issues as they relate to other areas
- Maintains substantial knowledge of principles and theories and acts as a technical lead on various projects
- Leads the development of intellectual property
- May utilize working knowledge of other related disciplines to provide solutions to a wide range of difficult problems
- Ability to work as part of and lead multiple teams
- Good leadership, mentoring skills and abilities typically leads lower levels and/or indirect teams.
- Excellent communications, problem-solving, analytical thinking skills.
- Sees broader picture and longer-term impact on division/company.
- Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency.
- Excellent project management, strong project leadership skills.
- Ability to work in a cross functional team and matrix environment