Associate Director, Clinical Data Management

Lyra Therapeutics, Inc. is a clinical-stage therapeutics company leveraging its proprietary XTreo™ platform to enable precise, sustained, local delivery of medications to diseased tissues not accessible with conventional therapeutic approaches. Lyra's XTreo™ platform is comprised of a biocompatible mesh scaffold, an engineered elastomeric matrix and a versatile polymer-drug complex. The company's current pipeline of therapeutics target tissues deep in the ear, nose and throat passages and are designed to deliver continuous drug therapy for up to six months following a single non-invasive, in-office administration. Lyra's lead product candidate, LYR-210, has initiated a Phase 3 clinical trial for the treatment of chronic rhinosinusitis (CRS) as an alternative to primary sinus surgery. Lyra's second product candidate, LYR-220, is entering Phase 3 clinical development and is designed to be an alternative to revision CRS sinus surgery and post-surgical medical management. Headquartered in the Boston area, Lyra Therapeutics was founded by George Whitesides and Robert Langer, academic luminaries in the fields of chemistry, materials science and biotechnology.

Reporting to the Vice President, Biometrics, the Associate Director, Clinical Data Management is responsible for leading all clinical data management activities for one or multiple projects including CRF design, database development, processing external data, medical coding, data review, SAE reconciliation, and database close/lock procedures in accordance with ICH Guidelines and company requirements. Additionally, this role is responsible for the Data Management timeline, budget, quality management, vendor relationship and the facilitation of all projects requiring the data management support.

A successful candidate will have had experience contributing strong Data Management knowledge and consultation to a clinical program team, as well as to other stakeholders within Development. This role will be the company subject matter expert (SME) to DM process and technical/systems improvement initiatives.

Key Areas of Responsibility:

• May act as a functional DM expert for a specific DM specialty area, such as data standards, Medical Coding, data visualization, etc.
• Coordinate with the Vendor DM, Biostatistics, and Clinical on database UAT, edit checks, CRF completion guidelines, data management plans, data review plans, change control processes, and other study-specific plans as required
• May contribute subject matter expertise to support process improvement initiatives (e.g., data storage infrastructure, Master Control) and SOP authorship
• Advocate for the DM position within study team meetings and oversee vendor staff supporting DM work
• Participate in study and department-level budget review activities for all DM tasks and line items
• Develop a strong partnership with vendor Lead Data Managers to ensure program level deliverables are on track
• Demonstrate subject matter expertise in all aspects of the Data Management (DM) discipline. Ability to support multiple studies concurrently with minimal oversight by functional manager
• Lead the data review meetings with Medical, Clinical, Biostatistics, and Programming in support of key reporting events or database lock plans
• Develop, generate, and review project progress and/or metric reports, reporting summary of findings and data trends from vendor databases

Qualifications:

• Strong computer skills, including database management software, reporting tools, medical coding tools, etc.
• Strong knowledge of medical terminology, including implementation and use of the WHO Drug and MedDRA dictionaries
• Solid cross-functional understanding of processes of data management, clinical programming, biostatistics, and clinical and the ability to support studies across multiple phases of development
• 8 plus years’ related experience in pharmaceutical or clinical research industries, with a minimum of 7 years’ experience as Data Manager, with progressive levels of experience with varying study types and phases (Phase III experience would be preferred)
• Knowledge of clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP), CDISC standards, and eCTD submission requirements
• BS/BA degree in a biological science, health-related, or computer science field
• Proven competence in managing delivery of multiple projects/programs independently through full data management study life cycle
• Professional communication skills, and excellent problem-solving, organizational and project management abilities
• Experience with EDC and ePRO systems/devices and the implementation of such systems
• Prior inspection and major (vendor) audit experience a plus

At Lyra, we value creativity, leadership, and collaboration. The company sees significant expansion opportunities for our platform, and look for people who are driven to succeed, innovative, and adaptable. We offer a competitive compensation and benefit package with opportunities to join a fast-paced, high performing team. For consideration, please submit CV.

Please visit www.lyratx.com for more information.