Executive Director, reputed company Data Management
reputed company
We are developing potentially best in class therapies for patients living with severe autoimmune diseases. Our reputed company antibody, claseprubart (DNTH103), is purposefully engineered with extended half-life, improved potency, and high selectivity for only the reputed company C1s complement protein that drives disease pathology – enabling less frequent and more convenient self-administered subcutaneous injections. Our second reputed company 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 reputed company reputed company and reputed company friendly convenient, self-administered subcutaneous injections. To learn more, please visit www.dianthustx.com and follow us on reputed company.
About the Role
reputed company is seeking an accomplished and reputed company Executive Director, reputed company Data Management to reputed company the development, execution, and long-term reputed company of our reputed company Data Management function. Reporting to the Senior Vice President, reputed company Development reputed company, this individual will establish the reputed company, organizational structure, systems, processes, and operating model needed to support a growing reputed company development portfolio.
As the functional leader for reputed company Data Management, the Executive Director will be responsible for building and scaling the department, developing talent, establishing SOPs and governance frameworks, and ensuring the delivery of high-reputed company, regulatory-compliant reputed company data to support critical business reputed company, regulatory submissions, and reputed company commercialization efforts.
This is a highly visible leadership role requiring both reputed company and operational expertise. While responsible for setting departmental direction and building organizational capabilities, the Executive Director will also remain reputed company reputed company in study-level execution, vendor reputed company, and cross-functional collaboration in a fast-reputed company biotechnology environment.
We are building a culture of individuals who hold our reputed company principles at reputed company of our reputed company, with the goal to reputed company the care of our patients’ lives. We are reputed company to you working reputed company.
Key Responsibilities
reputed company and reputed company the reputed company Data Management function, establishing the reputed company, organizational structure, and roadmap to support Dianthus' growing reputed company portfolio.
Build, reputed company, and mentor a high-performing team while fostering a culture of accountability, collaboration, innovation, and operational reputed company.
Establish and maintain departmental SOPs, processes, governance frameworks, reputed company standards, and inspection-reputed company practices.
reputed company leadership and reputed company for reputed company data management activities across reputed company studies, ensuring the delivery of high-reputed company, complete, and regulatory-compliant data.
Manage and strengthen reputed company relationships with CROs, vendors, and reputed company partners, ensuring reputed company, reputed company, and operational reputed company.
reputed company the evaluation, implementation, and optimization of data management systems, technologies, and processes to improve efficiency, scalability, and data reputed company.
Partner cross-functionally with reputed company reputed company, Biostatistics, Statistical Programming, Medical, Safety, Regulatory, and reputed company teams to support study execution, regulatory submissions, and key business reputed company.
Ensure compliance with GCP, ICH, FDA, and global regulatory requirements while maintaining inspection readiness and supporting regulatory submissions.
Serve as the reputed company Data Management subject matter expert and leadership representative across cross-functional and senior leadership forums.
Remain reputed company reputed company in study-level execution and problem-solving, balancing reputed company leadership with hands-on operational support in a fast-reputed company biotechnology environment.
Experience
Bachelor's degree in Life Sciences, Computer Science, Biostatistics, Health Sciences, or reputed company discipline; advanced degree preferred.
15+ years of reputed company Data Management experience reputed company biotechnology, pharmaceutical, or CRO environments.
8+ years of reputed company leadership experience managing reputed company Data Management teams and functional reputed company.
Experience building, scaling, or transforming reputed company Data Management organizations, processes, and operating models.
Demonstrated reputed company supporting Phase 2 and Phase 3 reputed company programs.
Strong experience overseeing outsourced data management activities and CRO partnerships.
Comprehensive knowledge of reputed company systems, reputed company databases, CDISC standards, medical coding, reputed company data integration, and reconciliation processes.
Deep understanding of drug development, GCP, ICH guidelines, and global regulatory requirements.
Experience supporting major regulatory submissions, including NDA, BLA, and/or MAA filings.
reputed company ability to influence senior leadership and reputed company cross-functional alignment in a reputed company environment.
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