Senior Director, Quantitative & Clinical Pharmacology

The Importance of the Role
- Develop and execute translational, clinical pharmacology, and pharmacometrics strategies and deliverables from early through late-stage clinical development.
- Lead clinical dose selection and refinement across all phases of clinical development.
- Design and execute FIH and clinical pharmacology study designs.
- Develop and apply MIDD using population and statistically based methodologies.
- Use mechanistic and translational PK/PD approaches.
- Manage a team of scientists and serve as a SME on programs.

The Opportunity to Make a Difference
- Lead clinical pharmacology and pharmacometrics workstreams in CNS diseases (rare disease drug development experience preferred).
- Serve as therapeutic lead and SME in clinical pharmacology strategies, protocol preparation, study execution, data review/analysis, and study reports (siRNA/oligonucleotide experience preferred).
- Lead translational and mechanistically based PK/PD modeling to enable FIH dose selection and early efficacy/safety characterization using biomarkers and disease animal models.
- Lead pharmacometrics strategies across all stages (population PK, PK/PD modeling/simulations, meta-analysis, disease modeling).
- Support non-clinical PK/PD, ADME, and DMPK evaluations (strategy, design, execution, analyses) to inform lead optimization and candidate selection.
- Represent as functional lead for global regulatory activities and HA engagements; NDA and/or BLA experience is a must.
- Supervise, mentor, and develop scientists.
- Contribute to platform-based pharmacology activities across novel genetic modalities and indications.
- Publish manuscripts and advocate scientific leadership at external conferences.

Qualifications
- PhD in Clinical Pharmacology, Pharmacometrics, Pharmaceutical Sciences, or related field with ≥ 10 years’ experience in biotech or pharmaceutical industry.
- Expertise in clinical pharmacology and pharmacometrics; strong hands-on modeling and data analytics; proven regulatory success from IND through registration.
- siRNA and/or oligonucleotide experience (highly preferred).
- Demonstrated success leading and building high-performing teams with people development.
- Excellent communication, multitasking, and collaboration in cross-functional/matrixed environments.

Application Instructions
- Candidates should apply for this hybrid role.
- Hybrid: work on site at a U.S. facility and/or attend in-person company-sponsored events from time to time.
- Candidates must be authorized to work in the U.S.