Vice President, Development
Remote
Job Summary
Lead development sciences strategy and operations for genetic disease programs from candidate selection through first-in-human and early clinical development. Direct nonclinical PK/PD, DMPK, biomarker, and bioanalytical sciences while owning clinical pharmacology for Phase 1 and 2 studies. Provide quantitative leadership across data analytics and pharmacometrics to inform dose selection. Manage study execution, vendor relationships, and integrated development plans in partnership with Clinical Development, Regulatory, and CMC teams. Represent development sciences to senior leadership and the board to drive portfolio prioritization. This role requires a hands-on leader with deep scientific judgment to accelerate decisions in a fast-moving, early-stage environment.
Required Qualifications
- development sciences leader
- connect the dots from target engagement to first-in-human and early clinical proof of concept
- think in integrated development plans
- pair nonclinical pharmacology, DMPK, biomarkers, clinical pharmacology, and quantitative sciences into a coherent story
- de-risks programs and accelerates decisions
- hands-on by default
- energized by getting into the technical details
- drive the work forward in a fast-moving, early-stage environment
- partner naturally across Clinical Development, Regulatory, Research, and CMC
- bring deep scientific judgment to genetic disease programs
- ideally with direct experience advancing oligonucleotide and other novel modalities
- keep patients at the center of every development decision
- Provide scientific strategy and operational leadership across the development sciences functions
- take genetic disease programs from candidate selection through first-in-human and early clinical development
- Direct nonclinical PK/PD strategy spanning target engagement, pharmacodynamic response, and efficacy
- Oversee in vitro and in vivo ADME and DMPK characterization
- support candidate selection and IND-enabling packages
- Lead biomarker identification
- nonclinical-to-clinical biomarker strategy and execution
- Drive clinical biomarker qualifications
- support proof of mechanism and proof of concept
- Own first-in-human through Phase 2 early clinical sciences and development strategy
- Direct clinical pharmacology
- Phase 1 healthy-volunteer and special-population studies
- Provide leadership across data analytics, pharmacometrics, biostatistics, and data management
- inform dose selection and program decisions
- Oversee nonclinical and translational study execution
- vendor management
- Manage clinical pharmacology study execution
- associated vendor relationships
- Direct bioanalytical assay development
- PK, biomarkers, and immunogenicity
- Oversee nonclinical and clinical bioanalytical operations
- Partner closely with Clinical Development, Global Regulatory Affairs, CMC, and Research
- deliver integrated development plans and regulatory submissions
- pre-IND, IND, FIH, Phase 1/2
- Personally drive the technical work across these functions
- staying close to the science and the data
- leverage CROs and external partners
- Represent development sciences to senior leadership, the board, and external advisors
- contribute to portfolio-level prioritization and resourcing decisions
Desired Qualifications
- ideally with direct experience advancing oligonucleotide and other novel modalities
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