Role Description
The Director, Clinical Development Research Scientist will report to the Senior Vice President, Clinical Development and serve as a key clinical and scientific leader advancing Avalynβs 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.
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Lead one or more clinical trials.
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Partner closely with Clinical Operations, Biostatistics, Regulatory Affairs, Pharmacovigilance, Translational Science, Data Management, CMC, and other functions.
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Ensure clinical trial activities are scientifically rigorous, patient-focused, operationally feasible, and aligned with broader program objectives.
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Help shape development strategy, including study design, endpoints, development sequencing, risk assessment, data interpretation, and program-level decision-making.
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Provide medical and scientific expertise across multiple studies.
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Serve as a resource to investigators and external experts.
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Contribute to regulatory interactions, advisory boards, publications, and scientific presentations.
Qualifications
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Advanced clinical or scientific degree (e.g., DNP, APRN, MD, PhD or equivalent) with significant clinical research, clinical development, or relevant therapeutic-area experience.
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7β10+ years of experience in clinical research, clinical development, drug development, or a related field, including meaningful sponsor-side experience.
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Deep expertise in IPF, ILD, or pulmonary medicine, with a strong understanding of the treatment landscape and unmet patient needs.
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Demonstrated 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.
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Demonstrated ability to interpret clinical safety and efficacy data and translate findings into evidence-based, program-level development decisions.
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Experience contributing to clinical development strategy across multiple studies and/or development stages.
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Working knowledge of ICH-GCP and global regulatory requirements.
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Demonstrated experience managing, mentoring, and developing clinical development professionals.
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Excellent communication and collaboration skills.
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Strong scientific and clinical judgment.
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Ability to operate effectively in a fast-paced environment.
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Willingness to travel as needed for investigator meetings, advisory boards, site visits, scientific conferences, and other clinical development activities.
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Ability and willingness to travel up to 25% domestic and international.
Requirements
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Provide clinical and scientific expertise for Avalyn IPF/ILD programs.
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Develop and refine clinical trial strategies.
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Lead protocol development.
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Provide medical oversight to study teams and Medical Monitors.
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Serve as an IPF/ILD disease-area expert.
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Lead clinical data reviews and interpret emerging safety and efficacy data.
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Provide clinical and scientific leadership in the development and review of protocols and regulatory submissions.
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Build strong relationships with investigators, KOLs, external experts, CROs, and other external partners.
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Contribute to publication strategy and external dissemination of clinical development data.
Benefits
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Proposed pay range: $220,000 β $242,000 USD.