Pfizer Director, Clinical and Diagnostic Assay Development in Pearl River, New York
This is a senior position within Pfizer's Vaccines Research and Development. The incumbent will manage and oversee a group responsible for the development, qualification and validation of biofunctional assays (OPAs, SBAs, IVPA and viral neutralization assays) for preclinical and clinical development of various vaccine candidates. The incumbent and his/her group will also take responsibility of evaluating a number of vaccine candidates in small animal and NHP models. The incumbent will have responsibility for monitoring of team performance, assay improvement, and assay troubleshooting that pertain to Pfizer specific vaccine projects. It is the responsibility of the incumbent to prioritize projects, approve assay protocols and reports, and to assure the quality of data generated. This position operates with limited supervision and directs activities of junior and mid-level staff. All work is to be done in a compliant manner according to relevant SOP guidelines and cGLP/cGMP guidelines, when required. The position is located in Pearl River, NY, and reports to the Executive Director for Clinical & Diagnostic Assay Development.
Oversee the development, qualification and validation of various bio-functional assays to support both preclinical toxiciology and clinical testing.
Manage the development of in vivo potency assays and evaluation of novel adjuvants in animal models.
Provide scientific leadership, strong interpersonal and coaching skills through team roles and mentoring of scientists.
Act as the assay lead in the support of various vaccine programs.
Act as the representative of Pfizer's Vaccine Research and Development to attend different scientific or regulatory related meetings.
Satisfactorily completes all GLP and safety training conforming to Pfizer & Departmental requirements. Where applicable, performs job responsibilities in compliance with GLP and all other regulatory agency requirements.
Complete other jobs as assigned.
PhD in Immunology or related field
Minimum 10 years of post-graduate experience (preferably in industry but not required)
Expertise in the development, qualification and validation of clinical bioassays such as OPAs, SBAs, cell-based neutralization assays and in vivo potency assays
Knowledge of current ICH, USP and FDA guidance's on assay validation is required.
Possess sufficient statistical knowledge to facilitate interactions with staff statisticians.
Experience in managing junior and senior scientists
Strong verbal and written communication skills
Proficiency with personal computers including word processing, spreadsheets, PowerPoint and relevant scientific software
- Industry experience
EEO & Employment Eligibility
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Other Job Details:
Eligible for Relocation Package
Eligible for Employee Referral Bonus
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.