Clinical Development Medical Director in United States New York Pearl River

ROLE SUMMARY The Clinician Medical Monitor is accountable for providing medical and scientific expertise and oversight for Clinical Trials and serves as a single point of accountability for design, execution, monitoring, delivery and reporting of one or more clinical studies and to ensure patient safety. The clinician medical monitor may be required to design a development strategy for multiple protocols designed to obtain worldwide approval for a compound or group of compounds. In addition to study level activities, the clinician medical monitor may participate in standing committees, review compounds for potential in-licensing, including performance of due diligence reviews, and aid new business development on market opportunities and the target product profile. ROLE RESPONSIBILITIES Accountable for safety across the study Provide study team with medical advice for all medical issues during risk assessment and mitigation planning to enable quality, compliance and patient safety at the trial, site and patient level. Ensures development of and adherence to the Safety Surveillance Review Plan (SSRP). Consistent with the SSRP, performs and documents regular review of individual subject safety data, and performs review of cumulative safety data with the safety risk lead. As appropriate, the clinician medical monitor may delegate these responsibilities to the study clinician scientist identified in the SSRP. The specific components of safety data review are detailed in the appropriate SOPs and the “Safety Data Review Guide – for Clinicians.” Monitor study safety issues and provide input to serious adverse events (SAEs) reports. Provides appropriate medical context in terms of risk factors, medical history and other important medical factors required to put the SAE or AE into appropriate medical context required for benefit-risk assessm

Why Patients Need You Pfizer’s purpose is to deliver breakthroughs that change patients’ lives. Research and Development is at the heart of fulfilling Pfizer’s purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best-in-class medicines to patients around the world. What You Will Achieve As a Senior Associate Scientist, you will be at the center of our operations and you’ll find that everything we do, every day, is in line with an unwavering commitment to quality. You will be part of a team to support the preclinical evaluation and early clinical development of mRNA and protein based viral vaccines. You will be responsible for performing and developing immunoassays supporting various viral programs to monitor the immune responses elicited by vaccine candidates. You will be using your scientific knowledge to adapt and develop standard methods and techniques by applying prior work experience and consulting others. You should possess a strong work ethic and collaborative spirit and be adaptable to fast-paced environments. It is your innovative scientific temperament that will help in making Pfizer ready to achieve new milestones and help patients across the globe. How You Will Achieve It Perform assays to analyze immune responses to vaccine candidates that include (but are not limited to) cell culture, neutralization assays, other functional antibody assays, Luminex, and ELISAs in BSL-2 environments. Generate, characterize and tract critical reagents for preclinical bio-functional studies to support vaccine development. Assist with preclinical bio-functional assay development and t

ROLE SUMMARY The primary purpose of this job role is to function as a member of the Sample Logistics (SL) operations within Pfizer Vaccine Research and Development (VRD). The incumbent will be responsible for receiving samples from global clinical/study trials according to approved protocols and processes. The individual will participate in all aspects of tracking and documenting the chain of custody of samples. The incumbent’s role will include sample receipt, documentation, storage, tracking, aliquoting, distribution to the testing labs, and sample disposal. The colleague will work in a team setting and will share roles and responsibilities as assigned by the team leader/manager. ROLE RESPONSIBILITIES The incumbent will be required to complete all processes as detailed in Sample Management’s Standard Operating Procedures. The colleague will perform job responsibilities in compliance with GXP and all other regulatory agency requirements. The candidate will receive samples from clinical trial sites and enter samples into an electronic database management system. Performs sample storage and retrieval using manual freezers and BiOS (automated freezer storage system). Performs manual sample aliquoting and aliquoting using the Hamilton robotic instrument. Ship samples and lab supplies to external and internal testing labs. Assists in the general maintenance of the Hamilton robotic instruments. Participates in the shipment discrepancy resolution process. Completes documentation according to cGMP/GLP and all other regulatory agency requirements and archives documents as per applicable policies. Carries out sample disposal/sample destruction according to regulated policies and procedures Performs other duties as assigned. QUALIFICATIONS Must Have Bachelor of Science Degree or Bachel

ROLE SUMMARY The primary purpose of this job role is to function as a member of the Sample Logistics (SL) operations within Pfizer Vaccine Research and Development (VRD). The incumbent will be responsible for receiving samples from global clinical/study trials according to approved protocols and processes. The individual will participate in all aspects of tracking and documenting the chain of custody of samples. The incumbent’s role will include sample receipt, documentation, storage, tracking, aliquoting, distribution to the testing labs, and sample disposal. The colleague will work in a team setting and will share roles and responsibilities as assigned by the team leader/manager. ROLE RESPONSIBILITIES The incumbent will be required to complete all processes as detailed in Sample Management’s Standard Operating Procedures. The colleague will perform job responsibilities in compliance with GXP and all other regulatory agency requirements. The candidate will receive samples from clinical trial sites and enter samples into an electronic database management system. Performs sample storage and retrieval using manual freezers and BiOS (automated freezer storage system). Performs manual sample aliquoting and aliquoting using the Hamilton robotic instrument. <span style="color:#

Why Patients Need You Pfizer’s purpose is to deliver breakthroughs that change patients’ lives. Research and Development is at the heart of fulfilling Pfizer’s purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best-in-class medicines to patients around the world. What You Will Achieve As an Associate Scientist, you will be at the center of our operations and you’ll find that everything we do, every day, is in line with an unwavering commitment to quality. In this role, you will join a team of scientists focused on optimizing biologics reagents for vaccine programs. Your primary role is to support, assist and deliver reagents for nonclinical and clinical targets within Vaccines. Likewise, you’re expected to have a strong foundation in general scientific practice and the principles and concepts that will support meeting critical deadlines. You will be performing aseptic serological processing, preparation of buffers, and growing bacterial cultures, as necessary. All work is to be done in a compliant manner according to relevant SOP guidelines and GLP and/or GMP guidelines, as required. How You Will Achieve It Perform aseptic serological processing, reagent preparation, and bacterial culture growth to support high throughput clinical and nonclinical testing in Vaccines. Complete all work in compliance with SOPs, safety guidelines, and Good Laboratory Practice (GLP) requirements. Utilize time management, organization, detail orientation, and strong interpersonal skills to effectively perform tasks to support clinical immunology and diagnostics. Complete ad h

POSITION SUMMARY You will be responsible for managing the clinical sample logistics function for Pfizer’s vaccine clinical portfolio, ensuring samples are transported safely, compliantly, and reliably across domestic and international clinical trial networks to the Pearl River, NY biorepository and then distributed to our network of internal and external testing laboratories. You will lead an end-to-end logistics strategy from study start-up through operations and finally sample disposition. Your responsibilities include leading a large team, improving global logistics capabilities, advancing digital and automation initiatives, and partnering with Vaccines, Quality, Legal, Finance, Compliance, clinical study teams, couriers, and technology vendors. You will be accountable for maintaining sample integrity, enabling global clinical trial execution, and developing scalable logistics processes to support Pfizer’s vaccine pipeline. KEY RESPONSIBILITIES Lead the global sample logistics function--Provide strategic and operational leadership for a team of 40&#43; colleagues responsible for domestic and international shipment execution, study start-up support, ongoing operations, and clinical sample lifecycle management. Shape long-term sample logistics strategy. Develop scalable operating models, governance frameworks, and business continuity plans that support pipeline growth, clinical trial expansion, and evolving global regulatory expectations. Protect sample integrity and compliance. Ensure reliable, temperature-controlled movement of clinical biological samples while maintaining adherence to applicable FDA, EMA, IATA, DOT, CDC, trade compliance, GCLP, and Pfizer quality requirements. Advance inspection readiness and quality oversight. Maintain robust documentation and audit-ready processes for deviation management, CAPAs, change controls, an