Senior Director, Quantitative & Clinical Pharmacology

The Importance of the Role

This leadership role will be developing and executing translational, clinical pharmacology and pharmacometrics strategies and deliverables from early through late-stage clinical development. Key areas of emphasis will include but are not limited to clinical dose selection and refinement across all phases of clinical development, FIH and clinical pharmacology study designs, development and hands-on application of MIDD using population and statistically based methodologies, as well as mechanistic and translational PK/PD approaches.

This role will manage a team of scientists and serve as a SME on programs.

Key Areas of Emphasis

• Developing and executing translational, clinical pharmacology and pharmacometrics strategies and deliverables from early through late-stage clinical development
• Leading clinical pharmacology and pharmacometrics workstreams in CNS diseases (rare disease drug development experience preferred)
• Representing as therapeutic lead (siRNA or oligonucleotide experience is preferred) and SME in clinical pharmacology strategies, clinical study protocol preparation, study execution, data review/analysis, and study reports
• Leading the development and execution of translational and mechanistically based PK/PD modeling to enable identification of FIH dose, early characterization of efficacy and safety using biomarkers and disease animal models
• Leading and executing pharmacometrics strategies across all stages of drug development including population PK, PK/PD modeling and simulations, meta-analysis, disease modeling to inform clinical development
• Supporting non-clinical PK/PD, ADME and DMPK evaluations including strategy development, study design and execution, data analyses to inform lead optimization, candidate selection and nonclinical drug development
• Representing as functional lead for global regulatory activities and HA engagements (NDA and/or BLA experience is a must)
• Supervising, mentoring and developing a team of high-performing scientists
• Contributing to platform-based pharmacology activities across novel genetic modalities and disease indications
• Encompassing leading-edge knowledge in clinical pharmacology and pharmacometrics discipline, publishing manuscripts
• Advocating scientific leadership at external conferences and scientific community

The Opportunity to Make a Difference

Lead clinical pharmacology and pharmacometrics workstreams in CNS diseases (rare disease drug development experience preferred)

Represent as therapeutic lead (siRNA or oligonucleotide experience is preferred) and SME in clinical pharmacology strategies, clinical study protocol preparation, study execution, data review/analysis, and study reports

Lead the development and execution of translational and mechanistically based PK/PD modeling to enable identification of FIH dose, early characterization of efficacy and safety using biomarkers and disease animal models

Lead and execute pharmacometrics strategies across all stages of drug development including population PK, PK/PD modeling and simulations, meta-analysis, disease modeling to inform clinical development

Support non-clinical PK/PD, ADME and DMPK evaluations including strategy development, study design and execution, data analyses to inform lead optimization, candidate selection and nonclinical drug development

Represent as functional lead for global regulatory activities and HA engagements (NDA and/or BLA experience is a must)

Supervise, mentor and develop a team of high-performing scientists

Contribute to platform-based pharmacology activities across novel genetic modalities and disease indications

Encompass leading-edge knowledge in clinical pharmacology and pharmacometrics discipline, publish manuscripts

Advocate scientific leadership at external conferences and scientific community