The Global Clinical Supply (GCS) Clinical Research Pharmacist (CRP) is a position within the GCS Strategic Hubs (GSH) and will be based in Costa Rica. The GCS CRP will be reporting to the GCS Global Clinical Supply Strategic Hubs (GSH) Team Lead based in Costa Rica, with a matrix reporting relationship to the Director of Clinical Research Pharmacy or higher.

The Clinical Research Pharmacy delivers Pfizer Clinical Study Pharmaceutical Care which are the instructions and training that make the breakthroughs possible by partnering with clinical sites, helping them to provide the very best care to their patients enrolled in Pfizer clinical trials. By focusing on the needs of the patient throughout the development process by designing packaging, labels, and dosing tools that facilitate optimum use of the investigational products being studied The CRP delivers an exceptional clinical trial experience.

• Provide expertise across GCS on clinical site/pharmacy operations; aseptic preparation guidelines for injectables; clinical disease state and patient journey reviews.
• Provide support to GCS functional lines, Pfizer Research and Development (PRD) and Oncology Research & Development (ORD) on the creation of Investigational Product (IP) handling documents.
• 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.
• Provide consultation to clinical project teams on medication/device related issues, such as concomitant medications, exclusionary medications and patient compliance/adherence issues.

• Responsible for the provision of clinical pharmacy expertise to GCS functional teams (e.g. CSSM, CSIT, GCSO - clinical disease state and patient journey reviews) and Pfizer colleagues (e.g. PRD and ORD - clinical site pharmacy operations; aseptic preparation guidelines for injectables).
• Independently drive and own development and provision of urgent IP handling materials.
• Assess the risks associated with IP Handling as described in the protocol and develop a CRP Risk Assessment and Mitigation Strategy for study protocol with guidance.
• Provide patient focus support to the Clinical Supply Team (CST) in the design of clinical labeling and packaging for use in clinical studies.
• Support the provision of clinical pharmacy expertise to GCS functional teams and Pfizer colleagues.
• Support the development of clinical study protocols and Dosage Administration Instructions (DAI), 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.
• Provide consultation to clinical project teams on medication/device related issues, such as concomitant medications, exclusionary medications and patient compliance/adherence issues.
• Support the review and trending of Significant Quality Events (SQE) to identify potential risk indicators and mitigations.
• Support GCS matrix stakeholders & networks to promote greater understanding of IP handling challenges and solutions at clinical sites.
• Liaise with key partner and customer contacts (PRD and ORD) to gather clinical development plans, and review supply strategies in conjunction with the Supply Chain Leads (SCL).
• Interface with PRD and ORD Strategic Partners to lead Investigational Product (IP) handling strategy and execution associated with study management activities.
• Foster strong working relationships with internal (GCS functional lines) and external (i.e., Clinical Development & Operations (CD&O)) partners at Pfizer.
• Act as secondary Point of Contact for site personnel engaged in IP handling activities as an investigator site.
  
  
  • Review reports and provides site specific trackers/dashboards oversight to support IP handling activities.
  • Coordinate the IP for predictive patient enrollment to ensure adequate supplies are available.
  • Send shipment notifications and other IP handling reminders to investigator sites.
  • Engage with the CRP Lead for the assigned protocol(s) and with other GCS colleagues to support the clinical supply chain, including IP shipments, temperature excursions, IRT activities, inventory management, IP preparation, administration, and reconciliation.
  • Discuss and resolve IP manual issues and questions. Provide feedback and proactively create solutions and action plans to challenges observed for continuous improvement.
• Coordinate and perform quality control and retrospective review of IP manuals, IP dosing tools and related materials and programs.
• Act as the primary point of contact for the team in meetings, presentations, and other forums. Represent the team's interests and provide updates on project progress and engagements by creating comprehensive reports and outlining action items to ensure follow-through and accountability.
• Serve as the CRP representative in working groups across GCS functional lines, ensuring that the team's interests and perspectives are effectively communicated.
• Manage multiple moderately complex projects and meet targeted deliverables and deadlines. Develop plans for short-term work activities on projects (timelines, work plans, deliverables) within the team.
• Attend periodic meetings with teams in alternative global time zones, highlighting the role's requirement for global collaboration and communication.
• Use appropriate metrics to measure progress on goals, develop and implement key performance indicators (KPI) to track and measure progress towards strategic goals and ensure value-driven outcomes.
• Adapt and response quickly to changing business needs and deliver results in challenging first-time situation.
• Provide timely and actionable insights to stakeholders to support decision-making and strategic planning.
• Makes decisions independently to resolve moderately complex standard situations based on guidelines and policies. Conduct post-decision reviews to assess the effectiveness of decisions and identify opportunities for improvement.

• A degree in Pharmacy (PharmD preferred) with 5+ years of pharmacy practice or equivalent pharmaceutical/biotech industry experience.
• Hospital pharmacy experience required.
• Fluent in written and spoken English.
• Strong and effective verbal and written communication skills
• Excellent organization and interpersonal skills.
• Demonstrated organizational, project management, administrative, and technical skills
• Demonstrated strength in analytical skills and attention to detail
• Ability to prioritize and manage multiple complex projects and meet targeted deliverables and deadlines
• Ability to work independently seeking guidance as needed.
• Ability to function in a matrix model, collaborate in a team environment.
• Ability to adapt to changing situations and work well under pressure.
• Possess good business acumen.

• Clinical Research Experience (i.e. CRA/Monitoring)
• Sterile product compounding experience a plus.
• Excellent technical proficiency, including skills in use of common desktop tools (MS Word, MS Excel, MS Project, Visio); Office365 and SharePoint; tools for analysis and graphing and reporting (Power BI, Spotfire, etc.)
• Knowledge on global regulatory policies.