Executive Director – Bioanalytical Sciences

Job not on LinkedIn

🔥 3 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🔴 Lead

👔 Director

👻 Ghost score 11%

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Dianthus Therapeutics, Inc.

WebsiteLinkedInAll Job Openings

1 - 10 employees

Founded 2017

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $100M Private Equity Round on 2022-04

Healthcare • Biotechnology • Pharmaceuticals

Dianthus Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel monoclonal antibodies to treat severe autoimmune and inflammatory diseases. The company leverages advanced antibody engineering technologies to create next-generation complement therapeutics with improved selectivity and potency. Its lead program, DNTH103, is a monoclonal antibody targeting the classical complement pathway for conditions such as generalized Myasthenia Gravis, Multifocal Motor Neuropathy, and Chronic Inflammatory Demyelinating Polyneuropathy. Based in New York City and Waltham, Massachusetts, Dianthus aims to deliver transformative medicinal therapies by addressing unmet needs in autoimmune treatment.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

• 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