The leadership role will develop and execute translational, clinical pharmacology, and pharmacometrics strategies and deliverables from early through late-stage clinical development, managing a team of scientists and serving as a SME.
Responsibilities
- Lead clinical pharmacology and pharmacometrics workstreams in CNS diseases (rare disease drug development experience preferred)
- Serve as therapeutic lead/SME (siRNA or oligonucleotide experience preferred) for clinical pharmacology strategies, protocol preparation, study execution, data review/analysis, and study reports
- Develop and execute translational/mechanistic PK/PD modeling to enable FIH dose selection and early efficacy/safety characterization using biomarkers and disease animal models
- Lead pharmacometrics across all stages (population PK, PK/PD modeling/simulations, meta-analysis, disease modeling)
- Support non-clinical PK/PD, ADME, and DMPK evaluations (strategy, study design/execution, analyses for lead optimization and candidate selection)
- Act as functional lead for global regulatory activities and HA engagements (NDA and/or BLA experience required)
- Supervise, mentor, and develop scientists; contribute to platform-based pharmacology activities; publish manuscripts; present at conferences
Qualifications
- PhD in Clinical Pharmacology, Pharmacometrics, Pharmaceutical Sciences, or related field + β₯10 years biotech/pharma experience
- Expertise in clinical pharmacology/pharmacometrics, hands-on modeling/data analytics, and regulatory success from IND through registration
- siRNA and/or oligonucleotide experience highly preferred
- Proven team leadership; strong communication/collaboration
Benefits (as stated)
- Physical and Emotional Wellness; Financial Wellness; Support for Caregivers
Application instructions
- If youβre a solution-oriented critical thinker, apply.
- Must be authorized to work in the U.S.
- Hybrid; work on-site in the U.S. and attend in-person events as needed.