Company Overview:

Avalyn Pharma is developing innovative, targeted inhaled therapies for rare respiratory diseases, including idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). Avalyn completed an oversubscribed $175M Series C financing in September 2023 to advance our clinical-stage pulmonary fibrosis portfolio consisting of inhaled pirfenidone (AP01), inhaled nintedanib (AP02), and a fixed-dose combination of both (AP03). Currently, treatment for IPF and PPF includes oral antifibrotics, pirfenidone and nintedanib. Due to side effects, 30-50% of patients cannot tolerate these medications. Avalyn has developed inhaled formulations for these FDA-approved antifibrotics. AP01 has now been studied in over 150 patients with various forms of pulmonary fibrosis, over at least 48 weeks and some out to 4 years and is phase 2b ready. PK studies show that AP01 reaches thirty-five times the concentration in the lung with 1/15th of the systemic concentration compared to historic oral pirfenidone. AP01 has demonstrated efficacy, with a high dose achieving near stabilization of lung function and is well tolerated with fewer systemic adverse events vs. historic oral pirfenidone. We have also completed our a phase 1a study of AP02, an inhaled formulation of nintedanib, with phase 1b & 2 plans being developed. Phase 1a positive topline results were announced in March 2023, and AP02 was demonstrated to be safe and well tolerated in normal volunteers & IPF patients.

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.

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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.

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Qualifications

Education & Experience

· 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.