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 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.
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
Clinical Research Pharmacist: Principal Scientist Level:
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
A degree in Pharmacy (PharmD preferred) with 3 to 5 years of Clinical Pharmacy or equivalent pharmaceutical/biotech industry experience.
Hospital pharmacy experience required.
Completion of a post-PharmD Industry Fellowship or pharmacy practice residency is desirable.
Clinical Research Experience (i.e. CRA/Monitoring) pr
Travel is approximately 10% for this role
Position will require periodic travel to Cambridge, MA; Groton, CT; May include travel to clinical sites
CRP located in Groton, CT will require periodic travel to Andover, MA
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.
Other Job Details:
Additional Location Information: Onsite in Andover MA or Groton CT
Eligible for Relocation Package: yes
Eligible for Employee Referral Bonus: yes
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
Research and Development
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.