Clinical Research Pharmacist
• Support pharmacy services strategies and processes for supported clinical studies.
• Provide clinical pharmacy leadership to functional teams.
• Provide support to Global Clinical Operations (GCO) on the development of clinical study protocols, specifically providing clinical pharmacy guidance with the handling, preparation and administration of investigational products at clinical sites.
• Provide clinical pharmacy expertise in the development and management of investigational product handling manuals/pharmacy manuals for utilization by clinical sites.
• Educate clinical site personnel through in-services, investigator meetings and clinical site initiations or follow-up visits on the proper handling and use of investigational products, when necessary.
• Provide consultation to clinical project teams on medication/device related issues, such as concomitant medications, exclusionary medications and patient compliance/adherence issues.
• Provide clinical pharmacy expertise on program reviews
• As subject matter expert, interfaces with the clinical team in determining site capability and feasibility prior to site selection for on-site compounding, excipient and ancillary supply, and other special supply considerations. Liaises with Global Quality and Regulatory Compliance (GQRC) to ensure audit completion prior to study start as required. Interacts with PST (Parenteral Science Technology) for onsite compounding instructions and Global Regulatory Sciences with respect to country regulations.
• Interfaces with the clinical team to determining site capability and feasibility prior to site selection for on-site compounding, excipient and ancillary supply, and other special supply considerations.
• Liaises with Global Quality and Regulatory Compliance to ensure applied pharmacy practices align with local regulatory guidelines
• Interacts with Medical and Commercial teams to provide pharmacy expertise and guidance to support answers to questions from clinical or commercial site pharmacies.
Degree in Pharmacy (Pharm D preferred) with 5 -7 years of Clinical Pharmacy or equivalent pharmaceutical/biotech industry experience. Completion of a post-PharmD Industry Fellowship or pharmacy practice residency and hospital pharmacy experience is desired. Clinical Research experience preferred.
Excellent knowledge of clinical studies and the global clinical supply processes; viewed by peers as a leader with a high level of respectability and complete knowledge of processes and strategies.
Knowledge of cGMP and GCP regulations, ICH Guidelines as it relates to Good Distribution Practices (GDPs) and local country drug regulations.
Send resumes to firstname.lastname@example.org