Clinical Research Associate II

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description We are seeking a highly motivated, attentive, and self-driven candidate to join our team, Biologics Pivotal Formulation and Process Development, as a Senior Research Associate. Once onboarded, the successful candidate will contribute in developing formulation and drug product processes for innovative molecules in pivotal clinical and commercial stages. The candidate will have tremendous opportunities for career growth in a fast-paced and resource-rich environment through training and professional relationships. The ideal candidate is expected to be action oriented with high expectations of themselves and others. They should have good verbal and written communication interpersonal skills. <

ROLE SUMMARY The Workplace Experience Lead provides leadership, partnership, management and operational expertise to ensure approximately 2.5M sq ft of Groton, CT facilities support the advancement of the R&D pipeline. The site has the greatest concentration of specialty labs in the R&D network consisting of small molecule clinical manufacturing, GxP and non-regulated laboratories, vivarium, technical space (central utility plant) and office workspace facilities. Nearly every breakthrough therapy in the pipeline passes through Groton facilities and processes. This role will have direct oversight and accountability for the dedicated Clinical Research Unit (CRU) located in New Haven, CT and comprised of approximately 62.5K sq ft. This site is focused primarily on early-phase human clinical studies and contains 50&#43; patient inpatient beds. A critical element of the site’s performance is to ensure safe and compliant operations to meet and enable the aggressive timelines and evolving priorities of a first-in-class research organization. Therefore, making possible the delivery of commitments while providing an enabling and engaging work environment where colleagues and contractors can do their best work. ROLE RESPONSIBILITIES Serve as the primary onsite GWE point of contract for site leadership, coordinating responses, solutions, and opportunity resolutions through effective partnership for the entirety of the GWE soft services including but not limited to GMP cleaning, janitorial/housekeeping, food service, shipping and receiving, meetings and events management, churn moves and furniture, groundskeeping, pest control, snow removal, lab services and consumables, and new workplace services. Submit annual OpEx budgets for both the Groton and New Haven campuses (&#43;$11.9M) to the GWE Site Lead for review and approval and accountable for management and oversight to forecast targets. <

ROLE SUMMARY: The key strategic focus within the Internal Medicine Research Unit (IMRU) is identifying novel therapies to prevent or treat metabolic diseases such as obesity and cardiovascular disease. Our goal is to build a world-class research team of dedicated scientists committed to developing a deep mechanistic understanding of the metabolic pathways underlying disease pathogenesis. As a senior scientific leader and member of the obesity discovery biology team, this individual will play a significant role in shaping the scientific direction for the obesity therapeutic area and influencing broader IMRU research strategy and portfolio priorities. The individual will help create and drive discovery research strategy across multiple programs, including target ideation, validation, translational biomarker strategy, hypothesis testing, and early clinical development within the IMRU obesity portfolio. The successful candidate will lead through both direct team leadership and influence across multidisciplinary partners, helping align scientific decisions across discovery biology, translational sciences, clinical, computational, and external collaborators. The individual will identify emerging therapeutic opportunities, advance portfolio programs with scientific rigor and urgency, and represent research strategies to internal leadership and the external scientific community. Knowledge and experience in the study of metabolic pathways are essential, and familiarity with the pathophysiology of dysmetabolic states would be advantageous. Strong self-motivation, excellent communication and interpersonal skills, and the ability to lead, mentor, and build scientific capability in a highly collaborative environment are essential. ROLE RESPONSIBILITIES: Shape and influence the scientific direction for discovery research programs aligned with IMRU therapeutic area and portfolio strategy. Ap

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

Position Summary Pfizer is seeking a motivated Senior Associate Scientist to join the In Vivo Pharmacology group within the Oncology Research Unit, with a focus on antibody-drug conjugate (ADC) programs, but including other large molecule and small molecule programs. This role supports the execution of in vivo oncology studies that enable ADC discovery and preclinical development, including efficacy, tolerability, pharmacodynamic, and sample collection workflows. The ideal candidate will demonstrate strong technical aptitude, careful attention to detail, and a commitment to animal welfare, compliance, and high-quality study execution. The Senior Associate Scientist is expected to contribute as a dependable technical team member while building scientific understanding of oncology pharmacology and ADC-specific study requirements. Position Responsibilities Execute in vivo oncology studies supporting discovery programs using a variety of in vivo models including human cell line- derived, patient-derived xenograft, syngeneic models as appropriate with minimum guidance from study leads. Perform routine and advanced in vivo procedures, including tumor measurements, body weight monitoring, test article administration (IV, PO, subQ, IP dosing), clinical observations, and sample collection. Perform routine in vitro tissue culture procedures Support pharmacology studies evaluating efficacy, tolerability, pharmacodynamic biomarkers, dosing schedules, and combination approaches. Prepare study materials, confirm dosing and sampling schedules, and ensure study activities are performed according to approved protocols and SOPs. Maintain accurate, timely, and compliant study records using approved electronic data capture and documentation systems. Communicate study observations, technical issues, animal welfare concerns, and timeline risks promptly to managers and study line leads. Collabo

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