Executive Director – Bioanalytical Sciences

🕒 4 dias atrás

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

👻 Score fantasma 11%

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Dianthus Therapeutics, Inc.

SiteLinkedInTodas as Vagas

1 - 10 funcionários

Fundada em 2017

🏥 Saúde

🧬 Biotecnologia

💊 Farmacêutico

💰 $100.000.000 Private Equity Round em 2022-04

Healthcare • Biotechnology • Pharmaceuticals

Dianthus Therapeutics, Inc. é uma empresa de biotecnologia em estágio clínico focada no desenvolvimento de novos anticorpos monoclonais para tratar doenças autoimunes e inflamatórias graves. A companhia utiliza tecnologias avançadas de engenharia de anticorpos para criar terapias de próxima geração direcionadas ao sistema complemento, com seletividade e potência aprimoradas. Seu programa líder, o DNTH103, é um anticorpo monoclonal que tem como alvo a via clássica do sistema complemento para condições como miastenia gravis generalizada, neuropatia motora multifocal e polirradiculoneuropatia desmielinizante inflamatória crônica. Com sedes em Nova York e Waltham, Massachusetts, a Dianthus busca oferecer terapias transformadoras, atendendo necessidades médicas não atendidas no tratamento de doenças autoimunes.

Descrição

• Define and execute the company-wide bioanalytical strategy, operating model, standards, and capability roadmap • Lead bioanalytical support across research, translational, and clinical programs, including PK, pharmacodynamic, immunogenicity, neutralizing antibody, biomarker, and program-specific assays • Provide scientific oversight for assay strategy, platform selection, critical reagents, method development, qualification and validation, technology transfer, sample analysis, data interpretation, and assay lifecycle management • Ensure assays and data are fit for purpose, scientifically rigorous, compliant with regulatory expectations, and available for key program decisions and milestones • Resolve complex assay, data, quality, and vendor issues with Quality, program teams, and external laboratories • Own or oversee bioanalytical content for regulatory submissions, briefing packages, health authority interactions, responses, and development reports • Represent Bioanalytical Sciences on program teams and governance forums, communicating scientific conclusions, risks, trade-offs, resource needs, and recommendations • Build, lead, and develop the Bioanalytical Sciences function through organizational design, recruitment, coaching, performance management, succession planning, and capability development • Develop and manage resourcing across employees, CROs, specialty laboratories, consultants, and technology partners • Lead external laboratory evaluation, selection, contracting input, onboarding, governance, performance management, issue escalation, and relationship management • Own functional budgets, headcount plans, consultant needs, capacity forecasts, and resource allocation • Establish processes, metrics, systems, and vendor oversight practices supporting quality, speed, accountability, and inspection readiness; evaluate technologies improving scientific and operational performance

🎯 Requisitos

• PhD or advanced equivalent degree in biochemistry, immunology, pharmacology, analytical chemistry, molecular biology, or a related scientific discipline • Typically, 15 or more years of progressive bioanalytical experience in biotechnology, pharmaceutical, or CRO environments • Significant functional and people leadership responsibility • Demonstrated success leading bioanalytical strategy across multiple programs and development stages, from nonclinical development through clinical studies and regulatory interactions • Deep expertise in bioanalytical method development, qualification, validation, transfer, troubleshooting, sample analysis, data review, and assay lifecycle management • Broad knowledge of PK, pharmacodynamic and biomarker assays, ligand-binding assays, anti-drug antibody and neutralizing antibody assays, cell-based or functional assays, flow cytometry, molecular methods, and LC-MS/MS • Strong knowledge of global bioanalytical regulatory expectations, GLP and GCP-regulated work, data integrity, inspection readiness, and regulatory submission support • Proven experience building and leading high-performing teams and managing delivery through CROs, specialty laboratories, consultants, and other external partners • Demonstrated ability to manage budgets, headcount and capacity plans, prioritize resources across a portfolio, and communicate complex scientific and operational matters clearly to executives and cross-functional teams • Sound scientific judgment, strong cross-functional influence, and ability to operate effectively in a growing, fast-paced biotechnology environment

🏖️ Benefícios

• Remote work option • Opportunity to work on potentially best-in-class therapies for severe autoimmune diseases • Opportunity to build and lead the Bioanalytical Sciences function • Professional development through coaching, capability development, and succession planning responsibilities