Greater Boston
Toxicologist and translational safety scientist with industry experience for leading pharmaceutical companies. Support safety evaluation for diverse modalities in cardiometabolic, neuroscience, immunology and inflammation, oncology, and rare disease programs. Extensive scientific and regulatory experience in developing safety assessment strategies, pharmacology and safety biomarkers, model systems and analytical assays. Effective managerial and hands-on experience in conducting GLP and non-GLP safety/pharmacology studies, establishing laboratory capabilities and directing toxicologists, biologists and data scientists during drug development and regulatory filings. Excel in leading and participating on matrix teams, as well as managing CRO activities and facilitating projects from early discovery to commercial product support.
Serve as Subject Matter Expert and responsible for developing safety strategies for gene therapy and gene editing programs supporting rare disease portfolio; Serve as project and regulatory toxicologist accountable for stage-gate transitions, dossier preparation, responses to regulatory queries, and regulatory filings for programs spanning preclinical development to phase III clinical trials; Serve as drug safety lead during in-licensing reviews; Promote organizational and regulatory acceptance of innovative scientific approaches in regulatory packages to accelerate portfolio deliverables.
Head of Translational Systems Biology Group and Cambridge Site Lead of Comparative Biology and Safety Sciences. Lead strategic and scientific development of alternative approaches for translational sciences, leveraging human genetics and -omics, translational biomarkers, biochemical and structural modeling and human relevant in vitro platforms and assays; Coordinate cross function project teams to resolve safety issues and advance molecules during drug development and regulatory filings; Serve as company postdoc steering committee member and support company outreaching and postdoc/intern programs.
Head of Cellular and Molecular Toxicology Group. Lead predictive/translational safety efforts, with the focus on utilization of modern molecular tools and development of novel in vitro approaches to assess target biology and drug safety.
• Manage a group of talented scientists and coordinate cross function collaboration • Responsible for regulatory submissions and queries on preclinical toxicogenomics and mechanisms of toxicity studies • Lead drug target safety assessment using molecular, omics and imaging tools • Investigate mechanisms of toxicity and the relationship between pharmacokinetics and toxicity • Develop early safety strategies in animal models for small molecules and biological drug development and viral vector-based gene therapy • Develop strategies for predictive biomarkers and clinical translation
• Serve as Research Member Toxicologist for Virology and CNS indications • Build Molecular Toxicology and Toxicogenomic lab within Investigative Toxicology group. • Responsible for genomic profiling and biomarker analysis supporting preclinical safety assessment • Lead human genetics-based patient stratification on adverse events related to HIV drugs