Director / Senior Director, Clinical Development Scientist

Advanced degree in life/health sciences (PhD, PharmD, MD, MPH or equivalent) Deep understanding of rare disease, neurology, immunology, or a closely related field Extensive knowledge of drug development processes (late-phase trials), GCP/ICH standards, clinical operations, study design, safety monitoring, and statistics Demonstrated experience drafting and reviewing protocols, regulatory documents, medical monitoring plans, safety reports, etc. Excellent scientific writing ability and meticulous attention to detail Strong skills in data review, trend identification, data interpretation, and safety oversight Effective communication (written and verbal) with internal teams, investigators, CROs, regulatory bodies, and external experts Strategic mindset with ability to balance long-term goals and tactical needs Experience working across geographies and multimodal teams Proficiency in tools commonly used in clinical development (e.g. Microsoft Office, EDC systems, data platforms)

Serve as scientific lead on assigned Phase III/late-stage trial(s) Collaborate cross-functionally to support feasibility, site selection, study start-up, and execution across regions Oversee safety and efficacy data monitoring Support and contribute to the development of the overall Clinical Development Plan Maintain and apply knowledge of disease biology, competitive landscape, therapeutic modalities, and regulatory/scientific advancements Facilitate external relationships with sites, investigators, KOLs, CROs, and regulatory agencies Provide mentorship, guidance, and scientific oversight to team members Produce and support publications, presentations, and communications of trial findings