We are a family that is united by our commitment to making a meaningful difference in the lives of the patients and communities we serve. Fueled by the untapped potential of today’s medicines, we share a passion for imaginative solutions, and a relentless drive to do what others haven’t. Our focus is on bringing easier-to-use medicines, that have the potential to change lives, directly to patients.
If you are an authentic, purpose-driven, high-performing individual who embraces a “we, rather than me” business culture, and takes pride in representing both themselves and their organization with the highest level of integrity, join us on our journey. We would be honored to learn more about your aspirations to improve the lives of others.
On behalf of everyone at Xeris, “Thank You” for your interest in our Organization.
Please see all of our current openings below and apply today. Don’t see what your looking for? Submit your resume for general consideration here.
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The Manager of Device Development supports technical development and commercialization efforts for Xeris’ device and combination product programs. The Manager is responsible for supporting development of products according to Xeris’ Design Controls and product development processes. As part of a cross-functional team, project work will include all aspects of product development, design input, design output, specification development, test method development, design verification/validation, process validation, design transfer, as well as risk management. While Xeris uses contract development and manufacturing organizations (CDMOs), some of the work will be coordinated with internal departments. The Manager is also responsible for support in compiling the Device History File (DHF) and associated Regulatory submissions.
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The Director, Regulatory Drug Safety manages compliance with standard operating procedures, regulatory safety and pharmacovigilance in compliance with national and international regulations, such as the Food and Drug Administration (FDA) and World Health Organization, global, regional and country regulations for the reporting of adverse events to regulatory agencies.
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Based in San Diego, CA, the Human Resources Business Partner will serve as a strategic partner to Xeris’ Research & Development, Quality Assurance, Regulatory, Clinical Development and Corporate functions. This position will support these teams on recruitment, talent development & engagement, employee relations, onboarding and offboarding activities, and interpretation and adherence to company policies. The incumbent will collaborate closely with other HR team members to ensure alignment across the Company. Additionally, the position will be responsible for Company diversity and inclusion program development and oversight. This position reports to the Director of HR.
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The Manager, Regulatory Affairs serves as an expert in the oversight of all regulatory activities including filings required for clinical trials through to submission of marketing authorization applications. This associate will be responsible for building successful relationships and driving regulatory initiatives with cross-functional teams.
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The Documentation Coordinator, Regulatory Operations will support the coordination and preparation of clinical trial documentation and regulatory submissions. This role will assist with the review and evaluation of technical and scientific reports in support of regulatory submissions regarding company products.
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Xeris is searching for a Director, Biostatistics & Data Management to join our team in Chicago. This individual is a very senior biostatistician who provides technical expertise and statistical leadership. This individual will serve as the company leader in biostatistics for all clinical development programs and will provide oversight of data management activities. They will provide direction for clinical trial study design development, sample size and power calculations and provide input and consulting for future protocols. They will review and support regulatory filings in the US and Europe. They will assist with data management and statistical vendor reviews, selection, and oversight. This person will be responsible for setting up a standardized file structure and data repository for the company for final study database and statistical deliverables.
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The eTMF Assistant assists with adoption and onboarding of all clinical functions and 3rd party vendors for both eTMF system and processes. Provides ongoing support focusing on effective use of process, working closely with clinical operations teams and other functional areas.
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The Senior Director, Channel & Trade is responsible for developing appropriate market access strategies by channel leveraging the entire marketing mix to ensure patient access and base business growth. This position will lead the development, implementation, and execution of the channel marketing strategy for our lead products. This position will manage all trade and distribution in the US Market, formulate the strategic direction, engage in contract negotiation, and ensure effective administration of product inventory and distribution throughout the trade channel. This position will also manage price changes, line extensions, NDC changes, product allocations, and recalls.
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The Vice President, Clinical Development is a key role responsible for the strategy, direction and execution of the company’s clinical development plans. Responsible for all clinical research activities including development of clinical trial protocols, trial management and monitoring, data management and analysis and systems development of required reports and regulatory filings to gain product approval. The position will collaborate across multiple functions and external stakeholders in the execution of clinical research activities.
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Manages all aspects of clinical database design and reporting. Establishes and maintains policies and procedures for gathering, analyzing, and reporting clinical data. Standardizes data management procedures and documents for departmental operating procedures. Provides input to strategic decisions that affect the department. May give input into developing the budget.
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The Formulation Sr. Scientist will provide technical leadership for the development of pre-clinical and early clinical stage candidates using our proprietary technology for the delivery of small molecule and peptide/protein therapeutic agents. The successful candidate will be expected to drive programs from inception through preclinical manufacture/screening, technology transfer to selected CDMO’s, early cGMP manufacture working closely with Quality and CMC counterparts as well as any necessary analytical method development, specification development, and assessment of stability data/programs.
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The Analytical Sr. Scientist will support the development and registration of the company’s pipeline of preclinical- and clinical development-stage candidates. Defines and executes the overall analytical strategy for biologics, including leading the effort in managing and overseeing analytical method development, method qualification and transfer, and biophysical/biochemical characterization activities for recombinant antibodies and related biologic modalities. Provides leadership in developing a comprehensive analytical characterization strategy for biologics assets from pre-clinical through clinical development and commercial.
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The Clinical Project Manager will be responsible for the planning and management of the operational aspects of clinical trials, including CRO and vendor selection and management/oversight, ensuring project milestones and objectives are met and clinical study deliverables are consistent with program/company goals.
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The Manager, Clinical Trial Monitoring manages and provides direct supervision of all staff assigned to perform Clinical Monitoring functions, working closely with Clinical Operations to ensure all program milestones and goals are obtained.
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Xeris is looking for a Senior Clinical Research Associate to join their growing team in Chicago, IL. This position will work closely with the Clinical team to provide leadership in managing clinical trials. They will provide oversight in the site qualification, study start-up activities, implementation, monitoring, and close-out activities of multiple clinical trials and process-improvement activities.
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The Principal Clinical Regulatory Medical Writer is responsible for researching, writing, and editing clinical documents and summarizing data from clinical studies for submission to regulatory authorities and/or for publication or presentation.
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The Regional Medical Affairs Director (RMAD) is responsible for engaging with specified key thought-leaders (KTLs), institutions, and organizations in their assigned geographical region in the US through appropriate high level scientific support for research activities, publications, education, consulting, and other Medical Affairs initiatives. The RMAD will be the primary conduit for Medical Affairs communications and interactions for their assigned institutions & organizations.