Clinical Research Pharmacist
Job Description
Role 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:
Clinical Research Pharmacist: Principal Scientist Level:
- 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. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
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.
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.
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.
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