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Job Description
ROLE SUMMARY
This is a senior position within the Clinical and Diagnostic Assay Development group within Pfizer’s Vaccine Research and Development. Reporting to the Head of Serology and Diagnostic Assay Development, the incumbent will drive the strategy for evaluation of vaccine-induced immune responses by overseeing development of relevant in vitro assays such as antibody-binding serology assays, molecular diagnostics, and antigen-capture based diagnostics. The incumbent is expected to serve as immunology SME for vaccine program team(s) to which they are assigned.
This role involves collaborating on cross-functional teams and matrix collaboration and influence of other functions. The incumbent is also expected to apply their skills in assay development to support lifecycle management of multiple clinical diagnostics and/or serological assays that support vaccine pre-clinical and clinical studies. The position will lead or influence multiple managers who may have oversight of various types of assays ready for use in pre-clinical or clinical studies (e.g., molecular, immuno, or toxicological detection assays). The incumbent is accountable to line / senior management and project leadership. All work is to be done in a compliant manner according to relevant SOP guidelines and GCLP and/or CGMP guidelines, when required.
ROLE RESPONSIBILITIES
- Sets objectives for and manages multiple assay development projects. These may include serological, immunodiagnostic, molecular diagnostic, and/or toxicological diagnostic tests.
- Collaborate as necessary with the appropriate leaders/scientists within Vaccine Research and Development to drive strategy for evaluation of vaccine-induced immune responses.
- Interact with intra- and interdepartmental personnel in scientific discussions while advocating the appropriate assays to address the scientific questions. The incumbent may also to lead or support external collaborations and/or technology transfers.
- Immunology subject matter expert throughout assay lifecycle
- Author publications relevant to the work being performed
- Manage and diverse team of scientists at various levels
- Write and review reports, technical documents and presentations to support assay development, qualification, validation and transfer to high throughput clinical testing teams.
- Supervises laboratory staff including Managers.
- Keep abreast of new scientific/ technology development by participating in scientific meetings/ seminars and through regular scientific review; in-house new technology/approaches as appropriate
- Quality: Ensure that Pfizer’s values are reflected on a continuous basis in day-to-day job functions.
- Performs other duties as assigned.
QUALIFICATIONS
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.
PhD in Immunology or related field
10 -15 years of post-graduate experience (preferably in industry)
A strong background in Immunology and Molecular assay development is required
A background with primary authored publications is required
Proficiency with personal computers including word processing, spreadsheets, PowerPoint and relevant scientific software is required
Strong verbal and written communication skills are required
Assay development expertise is desired
Experience with vaccine clinical studies is desired
Experience interacting with regulatory agencies is desired.
Experience in managing scientists is desired
OTHER JOB DETAILS
Eligible for Relocation Package
Eligible for Employee Referral Bonus
#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
