Pfizer

Sr. Principal, Clinical Research Pharmacist

Employer
Pfizer
Location
Andover, Massachusetts
Salary
Competitive
Posted
October 21 2021
Ref
4828656
Position Type
Full Time
Organization Type
Pharma
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 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 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: Senior 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 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.
  • Clinical Research Experience (i.e., CRA/Monitoring) preferred.


PREFERRED QUALIFICATIONS
  • Completion of a post-PharmD Industry Fellowship or pharmacy practice residency is desirable.
  • Sterile product compounding experience a plus.


Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
  • Up to 10% travel may be required, domestic and international


Other Job Details:
  • Last Date to Apply for Job: November 17, 2021
  • Eligible for Employee Referral
  • Eligible for Relocation Package


#LI-PFE

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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.

Research and Development

#LI-PFE

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