Purpose/Objective of the job
• Provide pharmacy expertise in the development and management of investigational product at a program and protocol level (i.e pharmacy manuals for utilization by clinical sites)
• Provide expertise across Clinical Supply Chain and Clinical Supplies Operations on clinical site/pharmacy operations; aseptic preparation guidelines for injectables; onsite compounding.
• Support Clinical Supply Chain and Global Clinical Operations and Pharmaceutical Development on the development of clinical study protocols. Provide clinical pharmacy guidance with the handling, preparation and administration of investigational products at 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.
Key Responsibilities and Major Duties
• Support pharmacy services strategies and processes for CSC supported clinical studies.
• Provide clinical pharmacy leadership to CSC 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 CSC 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.
• As assigned, support CMR and demand activity for all assets that use the PET tracer technology in Radio-pharmacies
• Interacts with DPST (Drug Product Science and Technology), PST (Parenteral Science Technology) and Strategic Innovation to provide practical pharmacy expertise and experience to be used to help develop use time studies and practical product preparation methods.
• Additional tasks within scope of experience as assigned by supervisor in pursuit of BMS goals.
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.
Knowledge of pharmaceutical science normally attained through the achievement of a Pharm D, Bachelor's degree in Pharmacy or related science and a minimum of 5-7 years of experience in the pharmaceutical industry with a focus in clinical supplies.
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.
Demonstrated ability to work with and manage people/teams in a culturally diverse, complex, changing environment.
Demonstrated ability to effectively communicate and influence others to accomplish goals and objectives.
Demonstrated ability to develop others through leading by example.
Demonstrated ability to apply PD operating philosophy and operate within policies and procedures.
Knowledge of cGMP and GCP regulations, ICH Guidelines as it relates to Good Distribution Practices (GDPs) and local country drug regulations.