Director, External Laboratory Management, Vaccine R&D

Why Patients Need You

The Director, External Laboratory Management, Vaccine R&D is a senior leadership position in the High-throughput Clinical Immunoassays & Diagnostics (HCID) team within Pfizer Vaccine Research and Development (VRD). Reporting to the Head of External Laboratory and Reagent Management, this role will apply a diverse skill set to direct clinical assay projects with external partners including academic institutions, government laboratories, and contract research organizations (CROs) to ensure that the delivery of high-quality clinical assay results for Pfizer's vaccine research programs are executed in a timely and compliant manner. You will be an active member of VRD cross-functional teams, including clinical assay sub-teams and/or program teams, and will be expected to identify tools, technology, and business processes to achieve improved operations.

What You Will Achieve

Pfizer is making significant investment in the creation of novel, first-in-class vaccines, by combining internal discovery with external partnerships to produce vaccine candidates for the Pfizer pipeline. In this position, you will work to deliver a broad and deep pipeline of vaccine candidates by:

• Serving as point of contact for various functional groups to lead Pfizer's clinical sample testing and Pfizer-associated assays at external laboratories supporting Vaccine R&D programs.
• Working with Vaccine R&D functional leaders and their teams to identify opportunities for outsourcing.
• Leading technology transfer of biofunctional, ligand-binding, serological, and diagnostic assays.
• Directing clinical sample testing, monitoring of assay performance, assay investigations when needed, and providing general vendor oversight such as staff training, assay documentation, and scientific and organizational leadership to external laboratories.
• Working with CROs to identify opportunities for operational improvements; providing solutions and leading the implementation of such solutions to solve business challenges.
• Maintaining a 12-month master testing schedule and provide financial guidance for outsourced activities.
• Evaluating, critiquing, recommending, and qualifying external laboratories and/or their in-house assays for outsourcing of Pfizer clinical sample testing. Ensuring that assays performed at external laboratories supporting Pfizer clinical studies are qualified or validated (as appropriate) and assay-associated tasks performed at external laboratories are done in a compliant fashion, in accordance with prevailing SOPs, and GCLP/GLP/GMP regulations, as appropriate.
• Leveraging technical expertise across own and related disciplines to interpret and present experimental results; provide scientific, technical, and management direction to the external laboratory leaders and managers.
• Actively monitoring industry trends, models, and processes for outsourcing in order to work cross-functionally to identify and lead new opportunities for collaboration and outsourcing of Pfizer clinical sample testing needs.
• Directing the generation of contracts and agreements with external laboratories, including, but not limited to, master service agreements, quality agreements, and scope of work documents.
• Ensuring that Pfizer's values are reflected on a continuous basis in day-to-day job functions.

How You Will Achieve It

• Discuss current and long-term departmental requirements with supervisor.
• Serve as a primary scientific liaison with external alliance partners for vaccines, including collaborating companies, government agencies, and non-governmental organizations. Will communicate with external laboratory leaders and managers to ensure the smooth operation of assay throughput and associated activities supporting clinical sample testing, including (but not limited to) reagent preparation and qualification as well as exploratory sample acquisition and testing. Will provide scientific, technical, and management direction to the external laboratory leaders and managers. L ead through matrix responsibilities.
• Work closely with HCID Extended Leadership Team to provide updates on clinical sample testing, monitoring of assay performance, assay investigations, opportunities for operational improvements, and recommendations for potential new CROs. Provide input to leadership regarding resources, equipment, and supplies for operations that exceed $25M in annual budget.
• Adhere to GCLPs and other regulatory guidelines.
• Collaborate with senior leadership, peer colleagues, and first- and second-line managers from Research, Statistics, Research Informatics, Project management, and Data Management on a regular basis with assay transfer, development and troubleshooting projects. C ontribute to a culture that embraces continuous learning, development, and collaboration.
• Serve as point of contact and project representative to governance organizations, external scientific advisors, potential partners andother decision-making bodies, including information dissemination and the resolution of critical project issues.

Qualifications

Must-Have

• Bachelor's Degree (BA/BS) and 10+ years of experience.
• Excellent verbal and written communication skills, change agility, and problem-solving capabilities.
• Demonstrated skills and success in relationship building, negotiation, and influencing (both directly and indirectly).
• Ability to independently design, plan, execute experiments and interpret scientific data.
• Solid technical knowledge and hands-on experience with microbiology, immunology, molecular biology, biochemistry, and/or assay development.

Nice-to-Have

• Advanced Degree is desirable in microbiology, immunology, virology, biochemistry, or related discipline.
• Master's degree (MA/MS/MBA) and 9+ years of experience.
• Doctorate degree (PhD/PharmD/JD) and 7+ years of experience.
• Direct hands-on experience working in a regulated (GCLP/GLP/GMP) environment.
• Proven ability to define and lead projects, track and execute with quality and timeliness on complex programs of work.
• Ability to effectively manage competing priorities in a fast-paced environment and pivot appropriately to demands.

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.

PHYSICAL/MENTAL REQUIREMENTS

Ability to perform work while standing/sitting.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

This position may require weekend and evening work to meet critical business timelines.

This position will require occasional travel to scientific meetings, between Pfizer sites, to CROs, and other business-related travel.

#LI-PFE

Relocation assistance may be available based on business needs and/or eligibility.

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