- Location
- Remote
- Workplace
- Remote
- Department
- Clinical Development
- Seniority
- Director
- Education
- PhD
- Source
- Greenhouse
Description
About Us
We are developing potentially best in class therapies for patients living with severe autoimmune diseases. Our lead antibody, claseprubart (DNTH103), is purposefully engineered with extended half-life, improved potency, and high selectivity for only the active C1s complement protein that drives disease pathology – enabling less frequent and more convenient self-administered subcutaneous injections. Our second clinical candidate, DNTH212 is a first and potentially best in class, bifunctional inhibitor that targets clinically validated and complementary disease modifying mechanisms, Type 1 IFN suppression and B cell modulation – enabling potential for improved clinical outcomes and patient friendly convenient, self-administered subcutaneous injections. To learn more, please visit www.dianthustx.com and follow us on LinkedIn.
About the Role
The Executive Director, Head of Bioanalytical Sciences will lead the company’s bioanalytical strategy and execution across research, translational, and clinical development. Reporting to the Senior Vice President, Clinical and Translational Development, this individual will serve as the senior scientific authority for bioanalytical and biomarker assays and a key partner to program teams, senior leadership, Regulatory, Quality, Clinical Pharmacology, and external collaborators.
The successful candidate will combine deep assay expertise with strong people leadership, executive communication, and operational judgment. The role is accountable for building a scalable function, ensuring assay readiness and data quality, and managing resources across internal headcount, CROs, specialty laboratories, and consultants.
We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.
Key Responsibilities
- Define and execute the company-wide bioanalytical strategy, operating model, standards, and capability roadmap in alignment with portfolio priorities and development plans.
- Lead bioanalytical support across research, translational, and clinical programs, including PK, pharmacodynamic, immunogenicity, neutralizing antibody, biomarker, and other 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 applicable regulatory expectations, and available to support key program decisions and milestones.
- Lead resolution of complex assay, data, quality, or vendor issues in partnership with Quality, program teams, and external laboratories.
- Own or oversee bioanalytical content for regulatory submissions, briefing packages, health authority interactions, responses to questions, and development reports.
- Represent Bioanalytical Sciences on program teams and governance forums, clearly communicating scientific conclusions, risks, trade-offs, resource needs, and recommendations to technical and nontechnical audiences.
- Build, lead, and develop the Bioanalytical Sciences function, including organizational design, recruitment, coaching, performance management, succession planning, and capability development.
- Develop and manage a scalable resourcing model 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 across competing programs.
- Establish practical processes, metrics, systems, and vendor oversight practices that support quality, speed, accountability, and inspection readiness, while evaluating new technologies that improve scientific and operational performance.
Experience
- 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, including 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 relevant platforms, including 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, as applicable to the portfolio.
- 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 the ability to operate effectively in a growing, fast-paced biotechnology environment.
Skills
GCP