Director, Clinical Development

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $220k - $240k / year

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

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Avalyn Pharma

WebsiteLinkedInAll Job Openings

11 - 50 employees

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Avalyn Pharma is a biopharma company dedicated to developing innovative medicines aimed at treating rare lung diseases. The company is currently conducting the MIST Study, a Phase 2b clinical trial assessing the safety and efficacy of an inhaled version of pirfenidone, known as AP01, for patients diagnosed with Progressive Pulmonary Fibrosis (PPF). Through their research, Avalyn Pharma seeks to improve lung function and the overall quality of life for individuals suffering from this serious condition.

📋 Description

• Report to the Senior Vice President, Clinical Development • Provide IPF/ILD medical oversight, scientific leadership, and clinical expertise throughout the clinical trial lifecycle • Lead clinical trial strategy and protocol development, including endpoints, inclusion/exclusion criteria, and trial design • Define medical monitoring, safety, and risk mitigation strategies with the Medical Monitor • Contribute to statistical analysis plan assumptions and clinical relevance of statistical design • Support site identification and selection based on disease-area expertise • Provide medical input for trial amendments and study-specific regulatory interactions • Serve as disease-state expert and provide medical guidance to the Medical Monitor and clinical trial team • Review SAEs, SUSARs, safety signals, eligibility deviations, protocol exceptions, and violations • Support DSMB and Safety Review Committee materials • Ensure trial conduct meets GCP and patient safety standards • Lead cross-functional collaboration with Clinical Operations, Biostatistics, Regulatory Affairs, Pharmacovigilance, Translational Science, and external CROs • Provide medical guidance to site investigators and resolve clinical or disease-related questions • Conduct site visits as appropriate • Co-lead blinded data review meetings and interpret emerging safety and efficacy data • Lead medical interpretation of safety and efficacy outcomes for Clinical Trial Reports and support interim analyses and futility assessments • Lead development and authoring of the Clinical Study Report • Participate in regulatory agency interactions and co-lead EOP2 materials with Regulatory Affairs • Respond to health authority questions • Present clinical data at advisory boards and investigator meetings and support publications and congress presentations

🎯 Requirements

• Advanced clinical or scientific degree (e.g., APRN, RRT, PhD, PharmD) with 5–7+ years of experience in IPF/ILD clinical care, research, or drug development • A minimum of 3–5+ years of clinical development experience, with demonstrated involvement in the design and execution of Phase 2–3 clinical trials, preferably global studies • Therapeutic expertise in IPF, ILD, or a closely related respiratory disease area is required • Demonstrated expertise in clinical trial protocol development, including endpoints, eligibility criteria, safety monitoring, and risk mitigation strategies • Strong clinical judgment and commitment to patient safety, with experience evaluating safety signals, protocol deviations, and benefit-risk considerations • Experience reviewing and interpreting clinical safety and efficacy data and translating findings into meaningful clinical and development decisions • Working knowledge of ICH-GCP, clinical research standards, and global regulatory requirements, with experience supporting health authority interactions • Proven ability to lead and influence cross-functional teams and collaborate effectively with Clinical Operations, Biostatistics, Regulatory Affairs, Pharmacovigilance, Translational Science, and external partners • Excellent written and verbal communication skills, with the ability to effectively engage investigators, clinical sites, CROs, regulatory agencies, and internal stakeholders • Strong strategic thinking and business judgment, with the ability to connect trial-level decisions to broader clinical development and program objectives • Ability to work effectively in a fast-paced, collaborative environment and balance strategic responsibilities with hands-on involvement in clinical trial execution