Clinical Development Scientist, Director--Inflammation and Immunology (I&I) Non MD
Core
Lead and coordinate the development of multiple clinical studies for novel biologic and small molecule therapies in Inflammation and Immunology.
Role type
Director-level Clinical Development Scientist (Non-MD)
Builds
Clinical development programs for biologic and small molecule therapies
Domain
Biopharmaceuticals, Inflammation and Immunology
Required skills
Clinical protocol development, clinical study design, safety and efficacy data interpretation, regulatory document preparation, cross-functional team leadership, scientific writing, stakeholder influence, GCP compliance
Preferred skills
Immunology clinical development experience, Phase 2/3/late-stage program experience
Technologies
GDMS, pTMF, CORD, JReview, Signal Management
Responsibilities
Provide scientific leadership for study design and execution; lead clinical protocol and key document development; lead clinical data review activities; establish relationships with external experts and KOLs; foster cross-functional collaboration and process improvement.
Seniority
Director, hands-on IC with leadership responsibilities