Principal Research Pharmacist
Core
Lead the development and review of clinical research protocols, ensuring safe and effective use of investigational medicinal products (IMPs) in clinical studies.
Role type
Principal Research Pharmacist (Qualified Person)
Builds
Clinical trial protocols and IMP management systems for Phase I/IIa studies
Domain
Healthcare / Clinical Research / Pharmaceutical Development
Deliverable
client delivery
Required skills
Qualified Person (QP) registration, clinical pharmacology, Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), protocol development, pharmacokinetics/pharmacodynamics, safety data evaluation, audit management, team leadership
Preferred skills
Advanced training in clinical research or clinical pharmacology, experience in pharmaceutical development
Technologies
GMP facilities, clinical trial management systems
Responsibilities
Lead development and assessment of clinical research protocols; Collaborate with clinical teams and regulatory affairs on dosing and pharmacokinetics; Oversee management of IMPs including accountability and storage; Provide pharmacological expertise for safety data and adverse event evaluation; Oversee GMP processes at manufacturing sites; Release IMPs for use in clinical studies; Support on-site and vendor audits; Lead and guide pharmacy teams to promote best practices
Seniority
Principal, hands-on IC with mentorship
