Company Overview

Avalyn is a biopharmaceutical company developing inhaled therapies for the treatment of rare respiratory diseases including pulmonary fibrosis and other interstitial lung diseases (ILD). Pulmonary fibrosis is characterized by scarring of lung tissue, decline in lung function, reduced exercise capacity and quality of life, and is associated with increased mortality. Currently approved therapeutic options slow pulmonary fibrosis progression but are associated with significant toxicities that restrict their use and dosing. Avalyn is developing a pipeline of new inhaled formulations of approved medicines designed to reduce systemic exposure and deliver medication directly to the site of disease. Avalyn’s lead program, AP01, is an optimized inhaled formulation of pirfenidone, currently being studied in the ongoing MIST Phase 2b Study in progressive pulmonary fibrosis (PPF). Avalyn has initiated a Phase 1b study for its second program, AP02, inhaled nintedanib, that is being developed for the treatment of idiopathic pulmonary fibrosis (IPF). For more information, please visit avalynpharma.com and follow us on LinkedIn.

Position Summary

The Senior Clinical Data Manager (Sr. CDM) is a strategic and hands-on leader responsible for overseeing end-to-end data management activities across multiple global clinical trials. This role ensures the integrity, accuracy, and completeness of clinical trial data in compliance with Good Clinical Practice (GCP), regulatory guidelines, and company standard operating procedures (SOPs). The Sr. CDM serves as the primary liaison between internal teams, contract research organizations (CROs), and external vendors, providing oversight, guidance, and innovation in all aspects of data management. With deep expertise in data systems and standards, this role plays a critical part in accelerating timelines, supporting regulatory submissions, and driving the overall success of clinical development programs.

________________________________________

Key Responsibilities

Study Leadership & Strategy

Act as the lead data manager for assigned Phase II/III trials, ensuring timely delivery of high-quality, submission-ready data.

Provide strategic input into study designs, protocol development, and data collection strategies to optimize trial efficiency and data flow.

Author, maintain, and implement study-level data management plans (DMPs), CRF/eCRF specifications, edit checks, validation rules, and other key documentation.

Drive continuous alignment of data management strategy with overall program milestones and regulatory objectives.

Data Quality, Oversight & Delivery

Ensure accuracy, consistency, and completeness of trial data through ongoing review, cleaning, and reconciliation (SAE, labs, imaging, biomarkers, PK, PRO/ePRO, etc.).

Lead data review meetings, ensuring timely identification and resolution of discrepancies.

Coordinate interim analyses, database snapshots, and final database lock, ensuring data integrity for regulatory filings and publications.

Champion risk-based monitoring (RBQM), centralized data review, and technology-enabled approaches to enhance efficiency and reliability of data cleaning.

Cross-Functional & Regulatory Support

Partner with Clinical Operations, Programming, Biostatistics, Medical Monitoring, and Safety to ensure alignment of data deliverables with trial and submission objectives.

Deliver high-quality datasets, listings, and reports to support regulatory submissions (NDA, BLA, MAA) and health authority inspections.

Collaborate on clinical study reports (CSRs), publications, and scientific presentations, ensuring data accuracy and consistency.

CRO & Vendor Management

Provide oversight, governance, and quality management of CRO data management deliverables, holding vendors accountable to timelines, budget, and quality.

Review and approve vendor data transfer specifications, reconciliation reports, quality metrics, and compliance documentation.

Proactively identify and escalate risks, implementing corrective actions to ensure successful partnership and delivery.

Process Improvement & Innovation

Contribute to the development and refinement of company SOPs, standards, and best practices for clinical data management.

Drive adoption of CDISC standards (SDTM/ADaM), emerging technologies, and automation tools to streamline data flow and analysis.

Act as a thought leader in data governance, advanced analytics, and digital health solutions, continuously identifying opportunities to modernize data management practices.

________________________________________

Qualifications

· Bachelor’s degree in Life Sciences, Computer Science, or a related field; Master’s degree preferred.

· 10+ years of progressive experience in clinical data management within a biotech, pharmaceutical, or CRO environment (respiratory therapeutic area experience strongly preferred).

· Proven track record of leading global Phase II/III clinical trials through database lock and submission.

· Deep understanding of ICH-GCP, FDA, EMA, and other global regulatory requirements, including expertise in CDISC standards (SDTM, ADaM).

· Proficiency with EDC platforms (e.g., Medidata Rave, DFexplore) and clinical trial data systems. Medidata admin skills desirable.

· Strong leadership and project management skills, with the ability to manage multiple priorities in fast-paced environments.

· Exceptional problem-solving and analytical ability, with a focus on data integrity and risk management.

· Skilled communicator, able to influence and collaborate across cross-functional teams and with external partners.

· Vendor oversight experience with the ability to manage complex global partnerships.

· Technical proficiency in SAS, SQL, or other data programming languages highly desirable.

· Demonstrated ability to work independently, exercise judgment, and drive outcomes with minimal supervision.

What Avalyn offers

· The opportunity to contribute meaningfully to the development of life-changing therapies for patients with unmet needs

· A mission driven culture where you can make an impact

· Competitive compensation and equity package

· Comprehensive health and wellness benefits

· Flexible working arrangements, including remote/hybrid options