Executive Director – Bioanalytical Sciences

Dianthus Therapeutics, Inc.

. Define and execute the company-wide bioanalytical strategy, operating model, standards, and capability roadmap .

Posted 10/2/2026full-timeRemote • United StatesLeadWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Expertise in bioanalytical strategy, method development, and regulatory compliance, with a strong focus on leading high-performing teams and managing complex projects in biotechnology and pharmaceutical environments.

Highest-signal resume keywords

PhD In Biochemistry, Immunology, Pharmacology, Analytical Chemistry, Or Molecular Biology15+ Years Of Bioanalytical ExperienceBioanalytical Method Development And ValidationLeadership In Bioanalytical Strategy Across ProgramsKnowledge Of Global Bioanalytical Regulatory Expectations

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Bioanalytical Method DevelopmentAssay Lifecycle ManagementSample AnalysisData ReviewPK AssaysPharmacodynamic AssaysBiomarker AssaysLC-MS/MSFlow CytometryRegulatory Submission Support

Soft Skills

Cross-Functional InfluenceScientific JudgmentCommunication SkillsTeam LeadershipPerformance Management

Tools & Technologies

CRO ManagementSpecialty LaboratoriesConsultantsTechnology Partners

Industry Keywords

BiotechnologyPharmaceuticalGLPGCPData IntegrityInspection Readiness

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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