Job 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 Director, Clinical Quality Assurance (QA), will be responsible for end-to-end quality oversight of global clinical trials to ensure compliance with applicable regulatory requirements and internal standards.
Reporting to the Sr. Director, Clinical QA, you will provide independent quality oversight of clinical development programs, ensuring that clinical trial conduct, data integrity, and sponsor oversight activities meet expectations of global regulatory authorities (e.g. ICH, FDA, EMA, MHRA, etc.)
You will partner cross-functionally with Clinical Operations, Clinical Development, Data Management, Pharmacovigilance, Bioanalytical, CMC, and Regulatory Affairs teams, while working closely with other functions of the Quality Unit (e.g. Clinical Quality Systems and Quality Systems and Compliance) to ensure the global GCPs are met for our clinical studies and to support inspection readiness and quality system alignment. Your role will be integral in assuring Dianthus is always inspection ready. You must possess experience and skill collaborating and influencing CRO’s, laboratories, and other clinical vendors in order to be successful in this role.
This is a unique opportunity to join a rapidly growing organization and have a significant impact at Dianthus. 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
- Provide proactive, risk-based quality oversight for global clinical trials across all phases (e.g. Phase I, II, and III).
- Serve as the primary QA lead for clinical development programs, ensuring quality is embedded from study design through close-out.
- Ensure compliance with ICH E6 (R3) GCP and applicable global regulations (e.g. FDA, EMA, MHRA, etc.)
- Provide expert guidance on quality risk management, issue escalation, and mitigation strategies.
- Establish and maintain robust sponsor oversight frameworks for CROs and other third-party vendors.
- Ensure effective oversight of delegated activities, including monitoring, data management, and safety management.
- Collaborate with the Quality Unit to assess vendor qualification, performance metrics, and compliance trends.
- Lead and execute a risk-based GCP audit program, including investigator site audits, clinical vendor/CRO audits, and clinical process/system audits.
- Align audit strategy with clinical milestones and BLA readiness.
- Oversee audit findings, CAPAs, and effectiveness checks, ensuring timely and sustainable resolution.
- Ensure data integrity principles (ALCOA++) are embedded across clinical programs.
- Partner with the Director/Sr. Director of Clinical Quality Systems and the Sr. Director of Quality Systems and Compliance to support inspection readiness activities, provide audit insights and risk signals, contribute to inspection strategy and preparation.
- Participate in regulatory inspections as a QA subject matter expert.
- Act as a trusted advisor to Clinical Development and Operations leadership.
- Drive a culture of quality, compliance, and continuous improvement.
- Provide QA input and conduct QC of protocols, amendments, CSRs, and regulatory submission components.
- Provide quality oversight of bioanalytical activities, including review of bioanalytical method validation documentation to ensure alignment with regulatory expectations and clinical program needs.
- Lead or contribute to quality governance forums and risk review boards.
- Identify and assess systemic quality risks and compliance gaps
- Ensure appropriate classification and management of protocol deviations, serious breaches, and inspection findings.
- Escalate critical risks to senior leadership with clear, risk-based recommendations.
- Additional duties may be identified by functional management based on current project/business objectives.
- Some travel (approx. 20%) is required for company meetings and support of audits or regulatory inspections (e.g. in support of Sr. Director Quality Compliance as needed).
Experience
- BS or MS degree in life sciences or related field required.
- 12+ years of experience in GxP with minimum of 5+ years in GCP within the biotech or pharmaceutical industry.
- Deep knowledge of GCP regulations and guidance’s (e.g. ICH, FDA, EMA, MHRA, etc.)
- Significant experience supporting global clinical trials (e.g. Phase I, II and III).
- Demonstrated experience supporting or leading submissions and regulatory inspections (e.g. BLA, PMA, BIMO).
- Deep expertise of Sponsor oversight and CRO/vendor management responsibilities.
- Deep expertise in data integrity principles and risk-based quality management.
- Demonstrated experience in clinical audit strategies including investigator site audits, audit execution, and CAPA management.
- Experience working with or managing eQMS platforms and quality processes.
- Knowledge of Clinical Quality Systems.
- Experience with project management processes / tools to support in meetings, assist with project planning, and facilitate completion of tasks.
- Proven ability to lead strategically while remaining hands-on in a fast-paced biotech environment and risk-based thinking is critical.
- Proven capability to drive alignment and influence stakeholders across global, cross-functional organizations.
- Ability to translate regulatory expectations into practice, risk-based solutions.
- Excellent communication skills with the ability to engage senior leadership and regulatory inspectors.
