Sr Clinical Scientist
Core
Lead clinical study design, conduct, and regulatory documentation for dermatology products to ensure alignment with scientific rationale and regulatory guidance.
Role type
Senior Clinical Scientist (Clinical Development)
Builds
Clinical study protocols, Investigator's Brochures, Clinical Study Reports, and regulatory submissions for dermatology products.
Domain
Dermatology / Clinical Research / Pharmaceutical Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical study design (Phase I-III), regulatory documentation (IND/CTA, IB, CSR), ICH-GCP knowledge, data interpretation, cross-functional collaboration, vendor management
Preferred skills
Advanced degree (Master's, PhD, MD), clinical/biomedical background, IDMC participation experience, experience with Medical Writers
Technologies
TMF, IDMC charters
Responsibilities
Lead development of clinical study designs and protocols; manage development of study protocols, amendments, and CSRs; contribute to and author clinical sections of regulatory documents; review and interpret clinical data; provide scientific direction to Medical Writers; ensure document consistency and regulatory alignment.
Seniority
Senior, hands-on IC
