{"id":2104116,"url":"https://alion.io/job/avalynpharma-director-clinical-development-research-scientist","title":"Director, Clinical Development Research Scientist","company":{"id":9864,"name":"Avalynpharma","domain":"avalynpharma.com","url":"https://alion.io/company/avalynpharma","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":null},"role":"Science & Research","role_family":"Science & Research","seniority":"head","employment_type":null,"work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"board_field","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["United States"],"countries":["US"],"hiring_countries":["US"],"hiring_countries_total":1,"salary":{"min":220000,"max":242000,"currency":"USD","period":"year","gross":null,"usd_annual":242000},"salary_estimate":null,"experience_years_min":7,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Good Clinical Practice","optional":false}],"status":"live","first_seen_at":"2026-10-08T19:11:03Z","employer_posted_date":"2026-10-08","last_verified_at":"2026-10-25T06:18:03Z","board_verified":true,"closed_at":null,"days_open":16,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":16},"description":"About Avalyn:\nAvalyn aims to transform the treatment paradigm for pulmonary fibrosis and other serious, rare respiratory diseases. The company is advancing optimized inhaled formulations of established antifibrotic medicines designed to deliver drug directly to the lungs, enhance local efficacy, and reduce systemic side effects. Avalyn’s AP01 program is an optimized inhaled formulation of pirfenidone currently being evaluated in MIST, a global Phase 2b clinical trial in patients with progressive pulmonary fibrosis (PPF). AP01 has demonstrated encouraging safety and clinical activity across Phase 1b and an ongoing, multi-year open-label extension trial, with long-term data supporting the potential to preserve lung function while improving tolerability relative to historical oral pirfenidone. Avalyn’s AP02 program is an optimized inhaled formulation of nintedanib currently being evaluated in AURA, a global Phase 2 clinical trial in patients with idiopathic pulmonary fibrosis (IPF). Avalyn is also advancing AP03, an inhaled fixed-dose combination of pirfenidone and nintedanib, designed to deliver multiple antifibrotic mechanisms through a single lung-targeted platform. By leveraging its proprietary drug-device approach and deep expertise in rare respiratory disease development, Avalyn aims to establish a new standard of care in pulmonary fibrosis through inhaled, lung-targeted therapies. For more information, please visit avalynpharma.com and follow the company on LinkedIn.\nPosition Summary:\nThe Director, Clinical Development Research Scientist will report to the Senior Vice President, Clinical Development and serve as a key clinical and scientific leader advancing Avalyn’s IPF/ILD clinical development programs. This individual will provide therapeutic-area expertise and strategic leadership across the development lifecycle, from program and study strategy through protocol design, clinical execution, data interpretation, regulatory interactions, and development planning.\nThe Director will lead one or more clinical trials and partner closely with Clinical Operations, Biostatistics, Regulatory Affairs, Pharmacovigilance, Translational Science, Data Management, CMC, and other functions to ensure clinical trial activities are scientifically rigorous, patient-focused, operationally feasible, and aligned with broader program objectives.\nThis individual will help shape development strategy, including study design, endpoints, development sequencing, risk assessment, data interpretation, and program-level decision-making. The Director will also provide medical and scientific expertise across multiple studies, serve as a resource to investigators and external experts, and contribute to regulatory interactions, advisory boards, publications, and scientific presentations.\nThe successful candidate will bring a balance of strategic thinking and hands-on clinical development expertise, with the ability to translate emerging clinical data into actionable development decisions.\nResponsibilities:\nClinical Development Strategy & Program Leadership\nProvide clinical and scientific expertise for Avalyn IPF/ILD programs and contribute to broader portfolio and development strategy.\nDevelop and refine clinical trial strategies, including study sequencing, objectives, endpoints, patient populations, and overall program design.\nLead cross-functional development discussions and evaluate program risks, opportunities, and development alternatives to inform study design, sequencing, and resource priorities.\nProvide strategic clinical input into development plans, target product profiles, and key program milestones.\nStudy Design & Clinical Trial Leadership\nLead protocol development, including study objectives, endpoints, eligibility criteria, safety monitoring, and risk mitigation.\nProvide clinical and scientific leadership across multiple studies, ensuring consistency and scientific rigor across the development program.\nContribute to statistical analysis plan assumptions and assess the clinical relevance and interpretability of statistical approaches.\nProvide clinical oversight into study feasibility, investigator/site selection, protocol amendments, and study-level development decisions.\nPartner with Clinical Operations and CROs to support effective study execution while maintaining scientific integrity and patient safety.\nMedical Oversight, Safety & Data Interpretation\nServe as an IPF/ILD disease-area expert and provide medical guidance across assigned programs.\nProvide medical oversight to study teams and Medical Monitors, including assessment of patient safety, clinical risk, and disease-specific considerations.\nLead clinical data reviews and interpret emerging safety and efficacy data across studies.\nIdentify cross-study trends and translate findings into clinical and development recommendations.\nPartner with Biostatistics, Data Management, Pharmacovigilance, and Translational Science on data review, interpretation, and benefit-risk assessment.\nClinical Documentation & Regulatory\nProvide clinical and scientific leadership in the development and review of protocols, Investigator Brochures, Clinical Study Reports, briefing documents, and regulatory submissions.\nLead Clinical Study Report (CSR) authoring and ensure appropriate clinical interpretation of study findings.\nSupport FDA and other health authority interactions, including EOP2 meetings and responses to regulatory questions.\nContribute to regulatory strategy and translate clinical data and program strategy into clear, scientifically rigorous regulatory narratives.\nCross-Functional & External Leadership\nServe as a senior clinical leader on multidisciplinary development teams and provide clear recommendations to senior leadership.\nBuild strong relationships with investigators, KOLs, external experts, CROs, and other external partners.\nProvide clinical and scientific leadership at investigator meetings, advisory boards, and other external forums.\nSupport identification and engagement of clinical experts and investigators to inform program strategy and trial design.\nScientific Communications\nContribute to publication strategy and external dissemination of clinical development data.\nLead or support abstracts, posters, manuscripts, presentations, and scientific publications.\nPresent clinical development strategy and emerging data at investigator meetings, advisory boards, scientific congresses, and other external forums.\nMaintain awareness of evolving IPF/ILD literature, treatment paradigms, competitive developments, and standards of care.\nQualifications:\nAdvanced clinical or scientific degree (e.g., DNP, APRN, MD, PhD or equivalent) with significant clinical research, clinical development, or relevant therapeutic-area experience.\n7-10+ years of experience in clinical research, clinical development, drug development, or a related field, including meaningful sponsor-side experience.\nDeep expertise in IPF, ILD, or pulmonary medicine, , with a strong understanding of the treatment landscape and unmet patient needs.\nDemonstrated experience leading or contributing to Phase 2 and/or Phase 3 clinical trials, including strong experience in protocol development, clinical trial strategy, safety monitoring, and risk mitigation.\nDemonstrated ability to interpret clinical safety and efficacy data and translate findings into evidence-based, program-level development decisions.\nExperience contributing to clinical development strategy across multiple studies and/or development stages, with the ability to connect study-level decisions to broader program, portfolio, and product objectives.\nWorking knowledge of ICH-GCP and global regulatory requirements, with experience supporting health authority interactions and clinical/regulatory documentation.\nDemonstrated experience managing, mentoring, and developing clinical development professionals, with strong leadership and influencing skills and the ability to build high-performing teams.\nExcellent communication and collaboration skills, with the ability to engage effectively with investigators, KOLs, regulatory agencies, senior leadership, and cross-functional stakeholders.\nStrong scientific and clinical judgment, with the ability to evaluate benefit-risk considerations, make clear recommendations, and influence decisions across the organization.\nAbility to operate effectively in a fast-paced environment while balancing strategic responsibilities with hands-on clinical development activities.\nWillingness to travel as needed for investigator meetings, advisory boards, site visits, scientific conferences, and other clinical development activities.\nAbility and willingness to travel up to 25% domestic and international\nProposed pay range\n$220,000—$242,000 USD","description_format":"text","description_chars":8771,"description_truncated":false,"requirements":{"experience_years_min":7,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"phd","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Oncology Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-08T19:40:56Z"}],"visa":[],"liveness":{"score":77,"band":"hot","label":"Hiring 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