Source Job

• Lead the development, execution, and evolution of the Clinical Data Management function.
• Build and mentor a high-performing team while establishing SOPs, governance, and inspection-ready practices.
• Oversee data management activities across clinical studies, ensuring high-quality, regulatory-compliant data delivery.

Dianthus Therapeutics is a biotechnology company developing best-in-class therapies for patients with severe autoimmune diseases. It is a growing organization with a culture centered on core principles and patient care.

• Act as primary representative for eClinical Solutions and sponsor data management interaction, ensuring quality and timelines within scope.
• Define specifications and collaborate with technical teams on configuration of elluminate for data cleaning strategy and oversight.
• Perform quality oversight and data trending via elluminate reporting to identify risks and develop mitigation strategies.

eClinical Solutions helps life sciences organizations accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud. The company is a people-first organization with an inclusive culture, recognized as a 2025 Top Workplaces USA Award winner for Remote Work.

• Provide strategic leadership and oversight for all clinical data management activities across the development program.
• Partner with cross-functional leaders to ensure data integrity and support timely, high-quality decision making.
• Oversee vendor management, data governance, and delivery of inspection-ready clinical data.

Akero Therapeutics is a clinical stage biopharmaceutical company focused on developing transformational treatments for serious metabolic diseases like MASH. They are a team of problem solvers with a collaborative culture, dedicated to bringing out the best in each other.

• Lead operational execution of cell therapy trials from startup through close-out, managing timelines, budgets, and vendor oversight.
• Ensure compliance with regulatory standards including FDA, EMA, and ICH-GCP, and contribute to protocol development and study documents.
• Collaborate cross-functionally with clinical operations, data management, regulatory, and manufacturing teams to drive study success.

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for autoimmune diseases. They are guided by core values of collaboration and innovation, fostering a culture of ownership and clarity.

• 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.

• Ensures clinical trial databases meet project requirements by attending sponsor meetings and managing data management deliverables.
• Ensures proper execution of data management plans by collaborating with project team, defining edit checks, and maintaining documentation.
• Ensures accuracy and consistency of clinical databases by reviewing data, resolving issues, and tracking outstanding items.

Perceptive helps the global biopharmaceutical industry bring new medical treatments to market faster. With a global team, they emphasize collaboration, growth, and winning together.

• Provide operational leadership and oversight of clinical data management activities across studies, ensuring high-quality, inspection-ready data.
• Manage end-to-end data management from study start-up through database lock, with oversight of CROs, vendors, and internal stakeholders.
• Drive data quality, compliance, and continuous improvement, serving as primary Data Management representative on cross-functional teams.

Definium Therapeutics is a late-stage clinical biopharmaceutical company applying scientific rigor to psychedelics to develop accessible treatments for psychiatric disorders. It is headquartered in New York and publicly traded on Nasdaq under the symbol DFTX.

• Oversee CDM operations including CRF/eCRF design, validation programming, discrepancy management, and database development/production with a focus on quality and compliance.
• Provide oversight of CROs, vendors, and internal teams, recruiting and leading CDM staff to meet clinical trial timelines and budgets.
• Partner cross-functionally on data management issues, identify risks, and propose solutions to ensure inspection-ready, high-quality data.

Definium Therapeutics is a late-stage clinical biopharmaceutical company applying scientific rigor to psychedelics to develop accessible treatments for psychiatric and neurological disorders. Headquartered in New York and traded on Nasdaq (DFTX), the company is advancing a new generation of therapeutics with a focus on turning evidence into impact.

• Serve as the Clinical Scientist for one or more Phase 2/3 studies, contributing to study design, protocol development, and oversight.
• Lead data review and medical monitoring activities, identifying trends, deviations, and safety signals in collaboration with Medical Monitors.
• Support regulatory submissions, cross-functional partnerships, and scientific publications to advance clinical development.

Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies for autoimmune diseases. It is a growing company with a collaborative, fast-paced environment where individual contributions have significant impact.