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
We are building our Clinical team and need two Senior Clinical Trail Associates who are open to owning end-to-end processes. You will report directly to the respective Senior Director, Clinical Development Operations global leads.
As the Senior Clinical Trial Associate (Sr. CTA)/ Sr. Associate, you will play a crucial role in the Clinical Development Operations (CDO) department to support the planning, execution, and management of clinical trials in accordance with regulatory requirements and industry best practices. In this role, you will collaborate with cross functional study teams, clinical Research Organizations (CROs), and other external vendors to ensure the successful delivery of clinical study activities.
You must have experience supporting global clinical study teams in order to be successful. Experience in rare diseases is ideal, however not required. We are looking for someone who can grow with our organization and will continue to support your ongoing development. 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
- Provides support to assigned clinical studies, taking on various responsibilities to support project and study deliverables.
- Coordinates, attends and may lead study team meetings; ensures appropriate meeting scheduling and documentation, including creation, distribution and filing of meeting agendas and minutes.
- Maintains and generates applicable study trackers and documents (for example: action-decision log, storyboard, patient enrollment and IRB approvals).
- Monitors clinical trial insurance and license agreements across studies and work with vendors to ensure current agreements.
- Supports the development and review of study documents, including study manuals.
- Maintains knowledge and acts as team super-user or subject matter expert for study-related systems and processes.
- Manages deliverables and navigates changing priorities.
- Supports the clinical team with coordination and preparation for investigator meetings, PI calls, conferences as well as internal clinical meetings.
- Supports management of the Trial Master File according to Sponsor Oversight plan to ensure accuracy and completeness.
- Assists with study budget oversight, including invoice tracking, reconciliation and collaboration with cross-functional teams and vendors.
- Participates in vendor selection and management meetings (e.g., CROs, IVRS, Central Labs, etc).
Experience
- BA/BS degree or equivalent, relevant work experience.
- Minimum of 5 years’ experience working on clinical studies in pharmaceutical, biotech, or CRO setting preferred. Prior CTA experience required.
- Excellent interpersonal and communication skills with ability to work collaboratively across functional teams.
- Strong organizational and time management skills, and strong attention to detail.
- Knowledge of global regulatory and compliance requirements for clinical research.
- Experience with essential documentation for Trial Master Files required.
- Knowledge of drug development, clinical operation processes, medical terminology, and procedures according to FDA GCP/ICH regulatory guidelines.
- Excellence with MS Office products Word, Excel, SharePoint, PowerPoint.
- Experience working with clinical trial systems (CTMS, IRT, EDC) preferred.
