Director, Clinical Development Research Scientist

🔥 2 minutes ago

🇺🇸 United States – Remote

💵 $220k - $242k / 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

• Provide clinical and scientific expertise for Avalyn’s IPF/ILD programs and broader portfolio and development strategy • Develop and refine clinical trial strategies, including study sequencing, objectives, endpoints, patient populations, and overall program design • Lead cross-functional development discussions and evaluate program risks, opportunities, development alternatives, and resource priorities • Provide strategic clinical input into development plans, target product profiles, and key program milestones • Lead protocol development, including objectives, endpoints, eligibility criteria, safety monitoring, and risk mitigation • Provide clinical and scientific leadership across multiple studies • Contribute to statistical analysis plan assumptions and assess clinical relevance and interpretability of statistical approaches • Provide clinical oversight into study feasibility, investigator/site selection, protocol amendments, and study-level development decisions • Partner with Clinical Operations and CROs to support effective study execution while maintaining scientific integrity and patient safety • Serve as an IPF/ILD disease-area expert and provide medical guidance across assigned programs • Provide medical oversight to study teams and Medical Monitors, including assessment of patient safety, clinical risk, and disease-specific considerations • Lead clinical data reviews and interpret emerging safety and efficacy data across studies • Identify cross-study trends and translate findings into clinical and development recommendations • Partner with Biostatistics, Data Management, Pharmacovigilance, and Translational Science on data review, interpretation, and benefit-risk assessment • Lead development and review of protocols, Investigator Brochures, Clinical Study Reports, briefing documents, and regulatory submissions • Lead Clinical Study Report authoring and ensure appropriate clinical interpretation of study findings • Support FDA and other health authority interactions, including EOP2 meetings and responses to regulatory questions • Contribute to regulatory strategy and translate clinical data and program strategy into clear regulatory narratives • Serve as a senior clinical leader on multidisciplinary development teams and provide recommendations to senior leadership • Build relationships with investigators, KOLs, external experts, CROs, and other external partners • Provide leadership at investigator meetings, advisory boards, and external forums • Support identification and engagement of clinical experts and investigators • Contribute to publication strategy and external dissemination of clinical development data • Lead or support abstracts, posters, manuscripts, presentations, and scientific publications • Present clinical development strategy and emerging data at investigator meetings, advisory boards, scientific congresses, and other external forums • Maintain awareness of evolving IPF/ILD literature, treatment paradigms, competitive developments, and standards of care

🎯 Requirements

• Advanced clinical or scientific degree (e.g., DNP, APRN, MD, PhD or equivalent) with significant clinical research, clinical development, or relevant therapeutic-area experience • 7–10+ years of experience in clinical research, clinical development, drug development, or a related field, including meaningful sponsor-side experience • Deep expertise in IPF, ILD, or pulmonary medicine, with a strong understanding of the treatment landscape and unmet patient needs • Demonstrated experience leading or contributing to Phase 2 and/or Phase 3 clinical trials • Strong experience in protocol development, clinical trial strategy, safety monitoring, and risk mitigation • Ability to interpret clinical safety and efficacy data and translate findings into evidence-based, program-level development decisions • Experience contributing to clinical development strategy across multiple studies and/or development stages • Working knowledge of ICH-GCP and global regulatory requirements • Experience supporting health authority interactions and clinical/regulatory documentation • Experience managing, mentoring, and developing clinical development professionals • Strong leadership, influencing, communication, and collaboration skills • Strong scientific and clinical judgment and ability to evaluate benefit-risk considerations • Ability to operate effectively in a fast-paced environment while balancing strategic responsibilities with hands-on clinical development activities • Willingness and ability to travel up to 25% domestically and internationally