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Principal Scientist, DMPK

Alnylam Pharmaceuticals

United States; Cambridge, MAPrincipal
Sign in to applyVerified 2h ago
Location
United States; Cambridge, MA
Work model
On-Site
Level
Principal
Posted
2h ago

About this role

Overview

The successful candidate will be part of a team responsible for understanding the disposition mechanisms and pharmacokinetic/pharmacodynamic (PK/PD) relationships of oligonucleotide therapeutics and other emerging modalities. The candidate will work closely with colleagues across Research and Development as a Principal Scientist within Drug Metabolism and Pharmacokinetics (DMPK), providing scientific leadership and strategic guidance to advance programs from discovery through clinical development. Work arrangement: This is an in-office position based in Cambridge, Massachusetts, requiring regular on-site collaboration with cross-functional teams. Key Responsibilities • Develop and implement DMPK strategies to support discovery, candidate selection, translational research, and clinical development of oligonucleotide therapeutics and other drug modalities. • Design, execute, interpret, and communicate DMPK studies to characterize absorption, distribution, metabolism, excretion (ADME), PK/PD relationships, and translational pharmacology. • Collaborate closely with Research scientists to optimize tissue delivery, pharmacology, and candidate selection for advancement into development. • Partner with Toxicology, Clinical Pharmacology, Bioanalytical Sciences, Regulatory Affairs, and Project Leadership teams to integrate PK, PD, efficacy, safety, and biomarker data and inform development decisions. • Apply quantitative approaches, including modeling and simulation, to support dose prediction, translation, and development strategy. • Represent DMPK as a key scientific contributor on multidisciplinary, matrixed project teams and participate in program and governance discussions. • Lead or contribute to the preparation of DMPK reports, regulatory submission content, and responses supporting CTA, IND, NDA, and other global health authority filings. • Provide scientific mentorship and technical guidance to junior scientists and contribute to building DMPK capabilities across the organization. • Effectively manage multiple programs, deliverables, and priorities in a fast-paced environment while maintaining high-quality scientific output. • Present scientific findings and recommendations clearly and effectively to project teams, senior management, external collaborators, and regulatory agencies, as appropriate.

Qualifications

Required • Ph.D. in pharmacokinetics, pharmaceutical sciences, pharmacology, biomedical engineering, or a related scientific discipline. • Minimum of 6+ years of relevant industry experience in pharmaceutical or biotechnology drug discovery and development. • Strong understanding of ADME, pharmacokinetics, PK/PD principles, and translational pharmacology. • Demonstrated experience developing and executing DMPK strategies for discovery- and/or development-stage programs. • Direct experience contributing to CTA and/or IND filings, including preparation or review of relevant regulatory submission content. • Proven ability to work effectively and influence outcomes in highly matrixed, multidisciplinary teams. • Strong quantitative, analytical, and problem-solving skills, with experience integrating diverse datasets to drive decision-making. • Excellent written, verbal, presentation, and interpersonal communication skills, with the ability to communicate complex scientific concepts to diverse audiences. • Demonstrated ability to multitask, manage multiple projects simultaneously, meet timelines, and adapt to changing priorities. Preferred • Experience with oligonucleotide therapeutics, RNAi, ASO, antibody-oligonucleotide conjugates, peptides, antibodies, or other advanced therapeutic modalities. • Experience with modeling and simulation approaches, including population PK, PBPK, mechanistic PK/PD, or translational modeling. • Experience supporting regulatory interactions and responding to health authority questions. • Familiarity with biomarkers, translational medicine,

Listing verified 2h ago. Applications go through the company's official careers site.

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Principal Scientist, DMPK at Alnylam Pharmaceuticals, United States; Cambridge, MA | Yoinka