Senior Manager, Translational Modeling

🕒 Junho 23

🌲 North Carolina – Remoto

🌲 North Carolina – Remote

⏰ Tempo Integral

🟠 Sênior

🌎 Tradutor(a) / Intérprete

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BioCryst Pharmaceuticals, Inc.

SiteLinkedInTodas as Vagas

501 - 1000 funcionários

🏥 Saúde

💼 Consultoria

📦 Logística

💰 $450.000.000 Post-IPO Debt - BioCryst Pharmaceuticals em 2023-04

Healthcare • Consulting • Logistics

A BioCryst Pharmaceuticals, Inc. é uma empresa global de biotecnologia focada na descoberta, desenvolvimento e comercialização de novos tratamentos orais com pequenas moléculas e proteínas para doenças raras, notadamente o angioedema hereditário (AEH). Fundada em 1986, a BioCryst utiliza design de medicamentos guiado por estrutura, química medicinal e tecnologias avançadas para desenvolver medicamentos de primeira classe ou superiores, e trabalha em estreita colaboração com pacientes, grupos de apoio e parceiros globais para levar os tratamentos ao mercado.

Descrição

• Provide expert mathematical modeling to lead development of mechanistic modeling strategy for drug discovery, and early development through clinical with a strong focus on biologics, and protein therapeutics. • Lead the design, implementation, calibration, validation, and documentation of mechanistic modeling approaches to address MIDD questions across programs. • Develops PBPK, PK/PD, QSP models, and mechanistic pathway models, ensuring scientific rigor and consistency. • Drive translational modeling strategies to support discovery and early development decision-making. • Integrate data from multiple sources (in vitro, in vivo, and emerging datasets) to build robust translational models. • Collaborate closely with cross-functional stakeholders (DMPK, toxicology, bioanalytical, biology, clinical pharmacology) to ensure alignment and impact of modeling approaches. • Present modeling strategies, results, and recommendations to cross-functional teams and guide program discussions. • Guide study design and data generation strategies to maximize translational value. • Author and review modeling components of regulatory documents (e.g., IND-enabling packages, briefing materials) and support regulatory interactions as needed. • Promote and implement best practices in modeling workflows and ensure high-quality, reproducible outputs. • Evaluate and apply emerging methodologies, including AI/ML, to enhance modeling capabilities. • Coordinate modeling deliverables across assigned programs and ensure timelines and quality expectations are met. • Contribute to external scientific engagement through publications and conference presentations.

🎯 Requisitos

• PhD in systems biology, chemical, mechanical or biomedical engineering, biochemistry, physics, applied mathematics, bioinformatics, or scientific computing. • Minimum of 5 years of experience in pharma/biotech with significant experience in translational modeling. • Strong proficiency in scientific computing and programming, with strong preference for Matlab/SimBiology. • Extensive experience developing and applying mechanism-based mathematical models of biological systems. • Proven experience with MIDD approaches in particular with PBPK and QSP modeling workflows across multiple programs with a track record of translational modeling impacting program cadence/success. • Strong understanding of translational science and drug development from discovery through early development and related disciplines (pharmacometrics, pharmacology, pharmacodynamics, toxicology, bioanalytics). • Demonstrated ability to contribute to and guide program-level decision-making using modeling and simulation approaches. • Track-record of utilizing M&S to guide experimental design specific to modality-driven target hypotheses. • Strong analytical, problem-solving, and data interpretation skills. • Excellent written and oral communication skills with the ability to influence cross-functional teams.

🏖️ Benefícios

• Health insurance • 401(k) matching • Flexible work hours • Paid time off • Professional development opportunities