Pfizer Director, Head of Diagnostics in Pearl River, New York
The purpose of this position is to oversee and manage the Diagnostics Group within High-throughput Clinical Immunoassays & Diagnostics (HCID) within Vaccine Research and Development (VRD). This position's responsibilities include: (i) organization and managerial oversight of the development and qualification/validation of Diagnostics assays to support diagnostic assessments of designated advanced phase VRD programs; (ii) organization and managerial oversight of diagnostics assay clinical sample analysis and delivery of results to Clinical Research; (iii) guide the strategic direction of organization in meeting the diagnostics assay needs for VRD's vaccine pipeline; (iv) assuring appropriate levels of GCLP/GLP compliance, including documentation, specimen/data tracking, and audit readiness; and (v) maintaining and promoting laboratory safety and compliance. The incumbent will also be an active member of VRD cross-functional teams, including clinical assay subteams and/or program teams, as appropriate and assigned.
Manages the Diagnostic Assay organization within VRD HCID in order to meet the mission of the timely and efficient development, qualification/validation, and throughput of Diagnostic assays supporting Global VRD vaccine candidate clinical development.
Guides HCID leadership in the setting of the short- and long-term strategic direction and planning for a high quality & GCLP compliant diagnostic assay organization within VRD HCID ; management of people, technology and financial resources to complete mission; represent Pfizer VRD internally and externally as vaccine diagnostic assay expert.
Serve as expert in diagnostic assay technology including but not limited to 1. Detection of microbiological disease (viral and bacterial) through PCR-based molecular diagnostics; 2. Detection of microbiological disease (viral and bacterial) through antigen-detection diagnostics. Establish and oversees organizations monitoring of assay performance.
Actively participates in VRD cross-functional teams, including clinical assay subteams and program teams, as appropriate and assigned, to set and support project strategies and to ensure the timely completion of testing of clinical samples according to internal and external quality standards. Participate in, and contribute to, the development of strategies, reports and other support documents as needed to meet regulatory requirements.
Manages Diagnostic Assay group colleagues, especially direct reports, setting their annual objectives and collaborating with them to create development plans. Conduct regular performance discussions, ensuring their desired/mandates training/development and retention of talent. Conduct year-end performance appraisals and nominate deserving candidates for promotions.
Coordinates and prioritizes Diagnostic assay group efforts with other HCID functional areas and Global VRD Departments.Participate in scientific discussion with colleagues through internal meetings, journal clubs, and formal scientific seminars. Fosters strategic alignment through modern communication tools.
Ensures that the Diagnostic assay group's tasks and activities are performed safely; and regulated tasks/activities are performed in compliance with cGCLP/GLP and Pfizer/Regulatory agency requirements.
Guides and/or directs Diagnostic assay group staff as to priorities of projects, appropriate methodologies, and proper interpretation of Diagnostic assay data.
Establishes and nourishes an environment of continuous innovation and technological improvement across VRD HCID.Identify, develop, and deploy novel technologies into the organization for the assessment and quantitation of vaccine immune responses.
Manages an organization of approximately 20 to 25 colleagues; including both direct and indirect reports; provide leadership and managerial coaching to the Diagnostic Assay group's managers; develops and establishes talent plan to address both short- and long-term talent needs.
PhD in a scientific discipline such as immunology, microbiology, virology, bacteriology or biochemistry with at least 8 years (post-PhD) of experience. Experience in the use of PCR and antibody-based diagnostics for detection of microbiological disease. Strong verbal and written communication skills are required.
Prior managerial experience in an assay developmental or high throughput setting is preferred. A working understanding of assay qualification and validation, as well as biostatistics, as it applies to diagnostic assays, is a plus. Prior experience troubleshooting or improving assay performance, electronic data systems and assay processes is preferred. Training in a GCLP environment and other international regulatory guidelines is 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.
• Relocation eligible
• Eligible for employee referral bonus
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Research and Development