Executive Director – Bioanalytical Sciences

🕒 vor 1 Monat

🇺🇸 Vereinigte Staaten – Remote

⏰ Vollzeit

🔴 Experte

👔 Direktor

👻 Geisterscore 14%

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• Seit 40 Tagen offen.
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• Kein Gehalt angegeben.

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Dianthus Therapeutics, Inc.

WebsiteLinkedInAlle Stellen

1 - 10 Mitarbeiter

Gegründet 2017

🏥 Gesundheitswesen

🧬 Biotechnologie

💊 Pharmazie

💰 €100.000.000 Private Equity Round im 2022-04

Healthcare • Biotechnology • Pharmaceuticals

Dianthus Therapeutics, Inc. ist ein biotechnologisches Unternehmen in der klinischen Phase, das sich auf die Entwicklung neuartiger monoklonaler Antikörper zur Behandlung schwerer Autoimmun- und Entzündungskrankheiten konzentriert. Das Unternehmen nutzt fortschrittliche Antikörpertechnologien, um die nächste Generation von Komplementtherapeutika mit verbesserter Selektivität und Potenz zu schaffen. Sein führendes Programm, DNTH103, ist ein monoklonaler Antikörper, der auf den klassischen Komplementweg für Erkrankungen wie generalisierte Myasthenia Gravis, multifokale motorische Neuropathie und chronische inflammatorische demyelinisierende Polyneuropathie abzielt. Mit Sitz in New York City und Waltham, Massachusetts, verfolgt Dianthus das Ziel, transformative medizinische Therapien zu liefern, indem es bisher ungedeckte Bedürfnisse in der Autoimmunbehandlung adressiert.

Beschreibung

• 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

🎯 Anforderungen

• 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

🏖️ Vorteile

• 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

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