The Senior Principal Clinical Research Pharmacist (CRP) 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). He/she 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. Playing a supportive role to Clinical Supply Strategy and Management (CSSM), Medicinal Sciences, Worldwide Research, Development, and Medicine (WRDM) and Global Product Development (GPD) 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. Educating 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.
Organizational Relationships: • Reports to Director or Senior Director of Clinical Research Pharmacy • Liaise with key partner and customer contacts (WRDM and GPD) to gather clinical development plans, and review supply strategies in conjunction with the Supply Chain Leads (SCL). • Interface with Global Product Development Strategic Partners to lead Investigational Product (IP) handling strategy and execution associated with study management activities. • Strong partnerships with Global Clinical Supplies functional lines.
ROLE RESPONSIBILITIES: • Responsible for the provision of clinical pharmacy expertise to GCS functional teams (e.g. CSSM, DBO, CSO – clinical disease state and patient journey reviews) and Pfizer colleagues (e.g. WRDM and GPD - 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 Global Product Development (GPD) 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 • Lead multi-disciplinary initiative teams in the development and implementation of innovative products and processes to optimize investigational product use.
BASIC QUALIFICATIONS: A degree in Pharmacy (PharmD preferred) with 5-7 years of Clinical Pharmacy or equivalent pharmaceutical/biotech industry experience. Hospital pharmacy experience required.
Management experience preferred. Completion of a post-PharmD Industry Fellowship or pharmacy practice residency is desirable. Clinical Research Experience (i.e. CRA/Monitoring) preferred. Sterile product compounding experience a plus.
TRAVEL: Travel expectation is approximately 10% 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
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EEO & Employment Eligibility
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Other Job Details:
Additional Location Information: Located in Andover, MA or Groton, CT
Eligible for Relocation Package
Eligible for Employee Referral Bonus
2 openings. Employer will assist with relocation costs.
Internal Number: 4745233
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