Clinical Research PharmacistRole Summary: This role will provide clinical research pharmacy expertise in the development and management of investigational products at a program and protocol level (i.e. investigational product handling manuals/pharmacy manuals for utilization by clinical sites).
The Clinical Research Pharmacists will provide expertise across Global Clinical Supplies (GCS) on clinical site/pharmacy operations; aseptic preparation guidelines for injectables; clinical disease state and patient journey reviews.
Provide a supportive role to Clinical Supply Strategy and Management (CSSM), Medicinal Sciences, Worldwide Research, Development, and Medicine (WRDM) and Clinical Development and Operations (CD&O) on the creation of clinical study protocols and Dosage and Administration Instructions (DAI), specifically providing clinical pharmacy guidance with respect to the handling, preparation and administration of investigational products at clinical sites and to patients and caregivers.
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.
Role Responsibilities: Responsible for the provision of clinical pharmacy expertise to GCS functional teams (e.g. CSSM, ISO, CSO – clinical disease state and patient journey reviews) and Pfizer colleagues (e.g. WRDM and CD&O - clinical site pharmacy operations; aseptic preparation guidelines for injectables).Assess the risks associated with IP Handling as described in the protocol and develop a CRP Risk Assessment and Mitigation Strategy (CRP RAMS) for the protocol.Provide patient focus support to the Clinical Supply Team (CST) in the design of clinical labeling and packaging for use in clinical studies.Provide support to CSSM and Clinical Development and Operations (CD&O) on the development of clinical study protocols and 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, when necessary.Provide consultation to clinical project teams on medication/device related issues, such as concomitant medications, exclusionary medications and patient compliance/adherence issues.Qualifications: A degree in Pharmacy (PharmD preferred) with 3 to 5 years of Clinical Pharmacy or equivalent pharmaceutical/biotech industry experience.Completion of a post-PharmD Industry Fellowship or pharmacy practice residency is desirable.Hospital pharmacy experience required.Clinical Research Experience (i.e. CRA/Monitoring) preferred.Sterile product compounding experience a plus.Travel: Travel is approximately 10% for this role. Position will require periodic travel to Cambridge, MA; Groton, CT; May include travel to clinical sites. Note: CRP located in Groton, CT will require periodic travel to Andover, MA.
Organizational Relationships: Reports to Director or Senior Director of Clinical Research Pharmacy.Liaise with key partner and customer contacts (WRDM and CD&O) to gather clinical development plans, and review supply strategies in conjunction with the Supply Chain Leads (SCL).Interface with Clinical Development and Operations Strategic Partners to lead Investigational Product (IP) handling strategy and execution associated with study management activities.Strong partnerships with Global Clinical Supplies functional lines.Work Location Assignment: Hybrid
The annual base salary for this position ranges from $99,900.00 to $166,500.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share-based long-term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments.
EEO & Employment Eligibility: Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
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