Senior Manager, Biosample Manager, Precision Medicine
ROLE SUMMARY
The Clinical Genetics & Biospecimens (CGB) team in Pfizer's Early Clinical Development Precision Medicine Group is seeking a highly motivated Principal Scientist Sample Manager to support the operations of our outsourced BioBank. The role will support the Head of CGB and provide leadership to a small team focused on BioBank sample operations, as subject-matter expert on biofluid collection, tracking and management.
The successful candidate will direct the shipment, tracking, documentation, and management of biospecimens throughout their lifecycle with vendors and the partner long-term storage facility, from intake to distribution and destruction. The candidate will serve as an internal champion for maximizing the scientific benefit of the Pfizer biospecimen resources and will drive compliance through adherence to robust collection and management practices.
ROLE RESPONSIBILITIES
BASIC QUALIFICATIONS
PREFERRED QUALIFICATIONS:
Work Location Assignment:Flexible/Remote
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Relocation assistance may be available based on business needs and/or eligibility.
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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.
Medical
The Clinical Genetics & Biospecimens (CGB) team in Pfizer's Early Clinical Development Precision Medicine Group is seeking a highly motivated Principal Scientist Sample Manager to support the operations of our outsourced BioBank. The role will support the Head of CGB and provide leadership to a small team focused on BioBank sample operations, as subject-matter expert on biofluid collection, tracking and management.
The successful candidate will direct the shipment, tracking, documentation, and management of biospecimens throughout their lifecycle with vendors and the partner long-term storage facility, from intake to distribution and destruction. The candidate will serve as an internal champion for maximizing the scientific benefit of the Pfizer biospecimen resources and will drive compliance through adherence to robust collection and management practices.
ROLE RESPONSIBILITIES
- Provide operational and scientific leadership (matrix and/ or direct) to the BioBank operations group
- Develop, maintain and evolve infrastructure (i.e., template study documents, manifest templates and collection guidelines) for banked biospecimen collection in clinical trials
- Execute the technical and operational procedures for the collection, storage, shipment, distribution and destruction of biospecimens from Pfizer clinical trials
- Address queries and advise on sample inventories, sample-associated data, and clinical trial documentation as key sample management point of contact to research and clinical teams
- Lead and/or support the periodic strategic assessment of biospecimens in storage for continued retention of disposition; deliver documentation of assessment
- Monitor biospecimen collections at biorepository and Central Labs and drive disposition of samples in collaboration with clinical team members
- Define and report on key metrics related to biospecimen management, performance, and capacity
- Contribute to quality event investigations, and support implementation of corrective actions as needed to ensure compliance with sample management specifications and quality
- Propose innovative process improvements and best practices related to biospecimen management, and drive the implementation
- Represent sample management on cross-functional global or vendor teams as subject-matter expert
- Work collaboratively with Informatics Scientists, Consent Custodians, and sample managers to enable efficient delivery of biospecimen orders to researchers
- Assess and champion communication of the business value generated through biospecimen research across disease areas
BASIC QUALIFICATIONS
- Bachelor's degree or Masters' Degree with a minimum of 10years of experience in sample management; PhD preferred
- Minimum of 5 years of relevant experience in the Pharmaceutical or related Industry
- Expert knowledge of human biofluid types, and collection and storage conditions thereof, and familiarity with considerations for conditions that may impact sample quality
- Experience working in a biological sample bank strongly preferred, understanding of the end-to-end sample management lifecycle required
- Proven leadership in sample management and demonstrated experience in process assessment and implementation of improvements
- Experience in matrix or direct leadership of a team of scientists, developing and coaching others
- Ability to organize, prioritize, and manage workflows; high level of initiative and ability to work independently
- Advanced interpersonal skills to navigate a diverse organization and ability to build collaborative working relationships with supervisors, peers, suppliers, customers,
- partners and stakeholders
- Technical leadership including ability to apply project management methodologies to achieving reliable and quality documentation of sample movements
- Excellent oral and written communication skills
- Strong ability to write work guidance and training documents, and experience authoring SOPs
- Knowledge of LIMS/database query tools with Microsoft Excel
PREFERRED QUALIFICATIONS:
- Strong knowledge of the clinical trial process, conduct and GCP
- 10+ years of experience in the pharmaceutical industry; experience related to operational processes or systems in clinical trials is desired
- Previous experience with sample management software
Work Location Assignment:Flexible/Remote
\n
Relocation assistance may be available based on business needs and/or eligibility.
\n
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.
Medical