Director, Clinical Development Research Scientist

This is a fully remote position, open to applicants in United States.

📋 Description

• Offer clinical and scientific expertise for Avalyn’s IPF/ILD initiatives and overall development strategy.

• Create and enhance clinical trial strategies, encompassing study sequencing, objectives, endpoints, patient populations, and comprehensive program design.

• Direct cross-functional development discussions while assessing program risks, opportunities, alternative development paths, and resource priorities.

• Provide strategic clinical insights into development plans, target product profiles, and significant program milestones.

• Oversee protocol development, including objectives, endpoints, eligibility criteria, safety monitoring, and risk management.

• Deliver clinical and scientific leadership across various studies.

• Contribute to statistical analysis plan assumptions and evaluate clinical relevance and interpretability of statistical methods.

• Ensure clinical oversight in study feasibility, investigator/site selection, protocol amendments, and study-level development decisions.

• Collaborate with Clinical Operations and CROs to facilitate effective study execution while safeguarding scientific integrity and patient safety.

• Act as an IPF/ILD disease-area expert, providing medical guidance across assigned programs.

• Offer medical supervision to study teams and Medical Monitors, including evaluation of patient safety, clinical risks, and disease-specific factors.

• Lead clinical data assessments and interpret emerging safety and efficacy data across various studies.

• Identify cross-study trends and convert findings into clinical and developmental recommendations.

• Collaborate with Biostatistics, Data Management, Pharmacovigilance, and Translational Science on data review, interpretation, and benefit-risk assessment.

• Spearhead the development and review of protocols, Investigator Brochures, Clinical Study Reports, briefing documents, and regulatory submissions.

• Oversee Clinical Study Report authoring and ensure accurate clinical interpretation of study results.

• Facilitate FDA and other health authority interactions, including EOP2 meetings and responses to regulatory inquiries.

• Contribute to regulatory strategy and translate clinical data and program strategies into clear regulatory narratives.

• Serve as a senior clinical leader on multidisciplinary development teams, providing recommendations to senior leadership.

• Cultivate relationships with investigators, KOLs, external experts, CROs, and other external partners.

• Provide leadership at investigator meetings, advisory boards, and external forums.

• Assist in identifying and engaging clinical experts and investigators.

• Contribute to publication strategy and external dissemination of clinical development data.

• Lead or assist with abstracts, posters, manuscripts, presentations, and scientific publications.

• Present clinical development strategies and emerging data at investigator meetings, advisory boards, scientific congresses, and other external forums.

• Stay informed about 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 extensive experience in clinical research, clinical development, or a related therapeutic area.

• 7–10+ years of experience in clinical research, clinical development, drug development, or a related field, including substantial sponsor-side experience.

• In-depth knowledge of IPF, ILD, or pulmonary medicine, with a robust understanding of the treatment landscape and unmet patient needs.

• Proven experience leading or contributing to Phase 2 and/or Phase 3 clinical trials.

• Strong background in protocol development, clinical trial strategies, safety monitoring, and risk management.

• Proficiency in interpreting clinical safety and efficacy data and translating findings into evidence-based, program-level development decisions.

• Experience contributing to clinical development strategies across multiple studies and/or stages of development.

• Familiarity with ICH-GCP and global regulatory standards.

• Experience in supporting health authority interactions and clinical/regulatory documentation.

• Experience in managing, mentoring, and developing clinical development professionals.

• Exceptional leadership, influencing, communication, and collaboration skills.

• Strong scientific and clinical judgment with the capacity to evaluate benefit-risk considerations.

• Ability to function effectively in a fast-paced environment while balancing strategic responsibilities with hands-on clinical development tasks.

• Willingness and ability to travel up to 25% domestically and internationally.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance.

• Generous paid time off and holiday policies.

• Opportunities for professional development and continuing education.

• Collaborative and inclusive work environment.