Play a critical role in supporting clinical development programs across the Dianthus portfolio, driving data quality and operational excellence.
Oversee all clinical data management activities and deliverables from study start-up through database lock and closeout across multiple clinical trials.
Ensure the delivery of complete, accurate, high-quality, and regulatory-compliant data to support study reporting, publications, and regulatory submissions.
We are developing potentially best in class therapies for patients living with severe autoimmune diseases. 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.
Lead design and execution of clinical trials for novel antibody-based therapies in rheumatology and I&I diseases.
Collaborate cross-functionally with clinical operations, regulatory, translational science to ensure robust study designs and data quality.
Interpret clinical data and present findings internally and externally, supporting regulatory submissions and scientific publications.
Spyre Therapeutics is a clinical-stage biotechnology company developing next-generation therapies for immunology diseases. As a small, young company, it fosters a fast-paced, collaborative culture focused on advancing meaningful medicines for patients.
Engage with healthcare professionals to exchange clinical, scientific, and research knowledge in alignment with regulatory guidelines.
Provide educational, scientific, and research support for Sobi's rare-disease product portfolio within the rheumatology franchise.
Serve as a field-based scientific expert, build relationships with key thought leaders, and support clinical development activities.
Sobi is a specialized biopharmaceutical company dedicated to developing and delivering innovative therapies for people with rare diseases. With over 1,900 employees in more than 30 countries, we foster a collaborative and inclusive culture that empowers employees to make a difference.
Manage data management vendors, ensuring quality through audits and key performance metrics.
Develop program-level DM deliverable timelines and drive internal/external negotiations.
Represent data management at cross-functional meetings, providing study status updates and escalating issues.
Ultragenyx is a biopharmaceutical company focused on developing treatments for rare diseases by challenging the status quo and applying a novel rapid development approach. The company fosters a supportive and inclusive culture of learning and growth, aiming to be an organization where employees can thrive.