Responsibilities:
- Drive DMPK strategy for Discovery and Development programs; represent DMPK function to project management and leadership.
- Coordinate, design, and interpret CRO-based Discovery/Development ADME evaluations for novel RNA therapeutics (radio-labeled; CYP/transporter DDI assessment; protein binding; plasma/blood cell partition; PK studies); guide project teams.
- Lead internal metabolism evaluation lab for metabolite ID using innovative methodologies and bioanalytical methods for ASO, siRNA, ligand-conjugated targeting strategies, and other modalities.
- Partner with medicinal analytical chemistry to optimize ADME characteristics during lead optimization.
- Provide expert guidance on IND-enabling ADME and PK studies from protocol through finalized reports.
- Author DMPK sections of regulatory submissions (IND/CTA, IB, NDA, etc.).
- Identify and manage CROs to ensure study execution/reporting meets timelines; build relationships with external consultants.
- Support PK modeling to inform clinical dosing strategies with PK/clinical pharmacology scientists.
Requirements:
- Ph.D. in relevant biomedical research; 12+ years DMPK experience in pharmaceutical drug discovery and development.
- Strong publication record and experience authoring regulatory submission documents.
- Proven ability to drive drug discovery from early development through candidate selection and IND.
- Deep expertise in drug metabolism and bioanalysis in NME programs, especially ASO/siRNA/RNA therapeutics.
- Experience with cross-species in vitro/in vivo ADME, mass balance, and DDI studies.
- Metabolite ID and method development; extensive LC-MS/MS, LC-ToF MS, LC-HRMS.
- Strong DMPK data interpretation and metabolismβPK relationships.
- Excellent written/verbal communication; ability to work in fast-paced interdisciplinary teams.
- Experience managing external vendors (CROs/consultants).
- Solid grasp of relevant ICH regulatory guidance for DMPK.
Application:
- Apply via website: http://www.ionis.com; reference requisition #IONIS004002.