Director, Clinical Development Research Scientist

Avalyn Pharma

. Provide clinical and scientific expertise for Avalyn’s IPF/ILD programs and broader portfolio and development strategy .

Posted 10/8/2026full-timeRemote • United StatesLead💰 $220,000 - $242,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates advanced clinical and scientific expertise in IPF and ILD, with a strong focus on clinical trial strategy, protocol development, and regulatory interactions. Proven ability to lead cross-functional teams and provide strategic input into clinical development plans while ensuring patient safety and scientific integrity.

Highest-signal resume keywords

Advanced Clinical DegreeClinical Trial Strategy DevelopmentIPF/ILD ExpertiseProtocol DevelopmentRegulatory Strategy

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical ResearchClinical DevelopmentDrug DevelopmentSafety MonitoringRisk MitigationStatistical AnalysisClinical Data InterpretationPhase 2/3 Clinical TrialsICH-GCP KnowledgeClinical Documentation

Soft Skills

LeadershipCommunicationCollaborationInfluencingMentoring

Industry Keywords

IPFILDPulmonary MedicineHealth Authority InteractionsClinical OversightClinical Development ProfessionalsEOP2 MeetingsScientific PublicationsClinical Study ReportsRegulatory Submissions

About the role

Key responsibilities & impact

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

What you’ll need

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