1+ months

Senior Director, Head of Immunoassays

Pearl River, NY 10965
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The purpose of this position is to oversee and manage the Immunoassay Group within High Throughput Clinical Testing (HTCT) within Vaccine Research and Development (VRD). This position's responsibilities include: (i) organization and managerial oversight of the development and qualification/validation of immunoassays to support immunogenicity assessments of designated advanced phase VRD programs; (ii) organization and managerial oversight of immunoassay clinical sample analysis and delivery of results to Clinical Research; (iii) Lead the strategic direction of organization in meeting the immunoassay 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.


+ Oversees and manages the Immunoassay organization within VRD HTCT in order to meet the mission of the timely and efficient development, qualification/validation, and throughput of immunoassays supporting Global VRD vaccine candidate clinical development.

+ Oversees and sets the short- and long-term strategic direction and planning for a high quality & GCLP compliant immunoassay organization within VRD HTCT; oversight of people, technology and financial resources to complete mission; represent Pfizer VRD internally and externally as vaccine immunoassay expert.

+ Serve as senior expert in immunoassay technology including but are not limited to 1. assessment of immunoglobulin levels via ligand-binding assays such as ELISA's, immunoglobulin bead-based assays (eg, Luminex) and novel technologies; 2. Assessment of vaccine-induced antibody functions including cell-based assay such as serum bactericidal assays (SBAs), opsonophagocytic assays (OPAs), toxin neutralization assays, and virus neutralization assays. Provide guidance to develop solutions to complex assay challenges and troubleshooting. 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 Immunoassay 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 Immunoassay group efforts with other HTCT 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 Immunoassay 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 Immunoassay group staff as to priorities of projects, appropriate methodologies, and proper interpretation of immunoassay data.

+ Establishes and nourishes an environment of continuous innovation and technological improvement across VRD HTCT.Identify, develop, and deploy novel technologies into the organization for the assessment and quantitation of vaccine immune responses.

+ Manages an organization of approximately 80 to 90 colleagues; including both direct and indirect reports; provide leadership and managerial coaching to the Immunoassay group's associate directors and managers; develops and establishes talent plan to address both short- and long-term talent needs.


**"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 a scientific discipline such as immunology, microbiology, virology, bacteriology or biochemistry with at least 12 years (post-PhD) of experience. 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 immunoassays, is a plus. Prior experience troubleshooting or improving assay performance, electronic data systems and assay processes is preferred. Training in a cGLP environment and other international regulatory guidelines is a plus.

**Other Job Details:**

+ Eligible for Relocation Package

+ Eligible for Employee Referral Bonus

+ \#LI-PFE

**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.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Research and Development
Posted: 2020-01-14 Expires: 2020-03-15

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Senior Director, Head of Immunoassays

Pearl River, NY 10965

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