The Manager, Clinical Supply and Logistics will be the liaison between the Clinical Research Operations team and the Technical Operations team to facilitate cross functional collaboration for proactive problem solving and alignment of end-to-end clinical supply chain management to support clinical trial execution. This position will be responsible for supporting the strategic planning and execution of new clinical trial supply chains on time and within budget and is tasked with supporting an integrated operating model with close collaboration with cross functional stakeholders.
Responsibilities
• Oversees clinical supply labeling, packaging, release, distribution, return and destruction at contract manufacturing organizations.
• Manages inventory globally at depots and sites including order management and proof of delivery confirmation, return or destruction and distribution logistics.
• Acts as a key interface between the Technical Operations and Clinical Research Operations teams to operationalize supply strategy to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans.
• Interprets protocol or study overview to calculate total demand and translation of total demand into a demand forecast over time.
• Manages clinical supply activities for clinical trials including clinical supply needs identification, determination of appropriate presentation to clinical site and participants and IP expiry date management.
• Collaborates with project team members including Technical Operations, Regulatory and Quality to design and implement drug labelling, packaging and supply strategies that not only meet the requirements of the study design, the clinical study sites, project timeline and the relevant regulatory authorities, but also maximizes efficiency of supply.
• Leads the logistics of the forecasting, planning, and distribution of ancillary supplies for all clinical trials in conjunction with senior team members.
• Coordinates supply strategies with internal Supply Chain/Technical Operations team and external packaging suppliers in conjunction with senior team members.
• Manages external clinical vendors including IRT vendors, as assigned, in conjunction with senior team members.
• Proactively identifies, prevents, and mitigates cross functional program risks related to clinical supply logistics.
• Work with the cross functional project team to ensure consistent communication of clinical trial material supply chain status.
• Collaborates with cross-functional study team members to ensure compliance of department/study activities with ICH guidelines, GxP, FDA and other applicable country regulations.
• Other tasks as requested by managers.
Qualifications
• Bachelor's degree (B.A./B.S.) or equivalent, preferably in life sciences or related discipline.
• 5+ years of related experience supporting clinical trial teams.
• Experience managing clinical trial vendors.
• A high level of proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook) is also required
• Competencies: Teamwork & Collaboration, Attention to Detail, Analytical skills, Organizational skills, Written and Verbal Communications, Adaptability, Time Management skills
• Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel. This is a hybrid position based in Xeris' Chicago office. A minimum of three days per week in the office is required. On-site requirements may change at management's discretion.
The level of the position will be determined based on the selected candidate's qualifications and experience.
#LI-HYBRID
As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors.
The anticipated base salary range for this position is $95,000-180,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process.
NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
$95k-180k yearly Auto-Apply 60d+ ago
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Associate Medical Director
Xeris Pharmaceuticals 4.2
Xeris Pharmaceuticals job in Chicago, IL
The Associate Medical Director will act as the Medical Monitor for Xeris clinical trials, collaborating with cross-functional study teams on clinical trial strategy, design and execution. In this role, the individual will oversee study conduct and safety monitoring for assigned trials, spanning Phases 1 through 3, and may also contribute to selected projects across multiple clinical development programs.
Responsibilities
Provides project physician support to clinical study teams during the execution of clinical research studies, including but not limited to protocol development, electronic Case Report Form (eCRF) development, therapeutic area training, protocol queries, patient eligibility determination, clinical/safety data review, and clinical summary report generation.
Serves on cross-functional teams for assigned trials, working with other team members to achieve efficient, high-quality study execution.
Contributes to the preparation of regulatory documents in support of regulatory submissions, including but not limited to clinical section of Investigational New Drug's (IND) application and Clinical Trial Agreement (CTA), IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/Institutional Review Boards , and other documents as appropriate.
Provides scientific and clinical input to study-related documents and analysis plans [e.g. informed consent forms (ICF), statistical analysis plans (SAP), clinical study reports (CSR)].
Performs other duties as assigned related to other aspects of Clinical Research.
Represents Xeris at clinical sites during studies and in external reporting of study results.
Up to 30% global travel
Qualifications
Medical Doctor (MD), Doctor of Osteopathy (DO), or non-US equivalent of MD degree with relevant therapeutic specialty in an academic or hospital environment.
Board certification/eligibility Internal Medicine, Endocrinology or another relevant medical field, is highly desired
Ability to run a clinical research study with minimal supervision
Clinical trial experience in the pharmaceutical industry, academia, or equivalent is desired
Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials
Excellent oral and written communication skills
Ability to work collaboratively in a fast moving, team-based matrix environment and to function independently as appropriate
This is a hybrid position based in Xeris' Chicago office and a minimum of three days per week on-site is required. On-site requirements may change at management's discretion.
The level of the position will be determined based on the selected candidate's qualifications and experience.
#LI-HYBRID
As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors.
The anticipated base salary range for this position is $200,000 to $260,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process.
NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
$200k-260k yearly Auto-Apply 60d+ ago
Associate Director, Biostatistics and Statistical Programming
Xeris Pharmaceuticals 4.2
Xeris Pharmaceuticals job in Chicago, IL
The Associate Director, Biostatistics and Statistical Programming will drive biostatistical activities, performed primarily by vendors, in support of project timelines and budgets related to drug product development at Xeris. The individual will contribute to study design, protocol development, case report form development, clinical study reports, and exhibits for other reports and presentations.
Responsibilities
Conducts basic statistical analysis of study data with minimal supervision according to a statistical analysis plan to generate results and insights used to support study findings.
Applies moderately advanced statistical methods, which may include simulation models and other statistical programming as needed, with guidance.
Generates sample size and power calculations and randomizations.
Oversees the review of statistical documents and operational activities outsourced to CROs ensuring adherence to cost, timeline, and data quality requirements to ensure that the analysis plans use the most appropriate statistical methods and that the data displays such as tables/figures/listings are accurate and complete.
Programs or independently validates key study results to support interpretation of data.
Provides statistical programming support to other clinical studies or regulatory submissions where another biostatistician is assigned as the sponsor lead.
Works closely with Data Management by providing input to data management-related documents and assisting with data review and cleaning activities, as needed.
Ensures compliance of data packages to regulatory requirements and CDISC and industry standards.
Assists in the development of abstracts, manuscripts, presentations for scientific congresses.
Closely collaborates and participates in knowledge sharing with other team members including non-statisticians to assist with interpretation and understanding of results.
Qualifications
MS/MPH degree in biostatistics, statistics, or epidemiology
A minimum of six years of clinical trial experience as a statistician and/or statistical programmer in the pharmaceutical, biotech, or CRO industry
Experience in Phases I-III of the clinical drug development process
Knowledge and basic understanding of statistical concepts and techniques commonly applied to the analysis of data from clinical trials and the ability to tackle from basic to moderately complex statistical or data issues
Basic understanding of real-world data and observational studies.
SAS programming experience required, R experience is a plus
Working knowledge of CDISC standards
Prior use and implementation of sample size and power calculation software (e.g., nQuery and PASS) preferred
Working knowledge of EDC systems
Competencies: Attention to Detail, Organizational skills, Adaptability, Multi-Tasking, Strong Written & Verbal Communication skills, Teamwork & Collaboration, Critical Thinking, Problem Solving, Presentation Skills
Working Conditions: This is a hybrid position based in Xeris' Chicago office. A minimum of three days per week on-site is required. On-site requirement may change at management's discretion. Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel.
The level of the position will be determined based on the selected candidate's qualifications and experience.
#LI-HYBRID
As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors.
The anticipated base salary range for this position is $140,000 to $240,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process
NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
$140k-240k yearly Auto-Apply 60d+ ago
Medical Writer
Xeris Pharmaceuticals 4.2
Xeris Pharmaceuticals job in Chicago, IL
Reporting directly to the Vice President of Clinical Development, the Medical Writer will be responsible for leading and executing all medical writing activities supporting Xeris' clinical programs. The individual will have a strong scientific background, exceptional writing skills, and a proven ability to translate complex clinical and scientific data into clear, accurate, and regulatory-compliant documents tailored to diverse audiences.
Responsibilities
Develop and author a broad range of clinical and regulatory documents, including but not limited to: clinical study protocols, investigator brochures (IBs), clinical study reports (CSRs), and sections of regulatory submissions (e.g., IND, NDA, etc.).
Ensure accuracy, clarity, consistency, and compliance with internal standards, applicable regulatory guidelines (e.g., ICH, FDA, EMA), and company SOPs.
Collaborate cross-functionally with colleagues in Clinical, Regulatory Affairs, Medical Affairs, and other internal stakeholders to gather relevant data and ensure consistency of messaging across documents.
Translate highly technical and statistical information into clear, concise content suitable for a wide variety of audiences including regulators, healthcare professionals, and non-scientific business leaders, as required.
Contribute to the development of communication materials, including slide decks, manuscripts, abstracts, and presentations, to support internal and external scientific communications.
Maintain document quality control through proofreading, editing, and adherence to templates, style guides, and version control procedures.
Manage timelines and priorities for multiple projects simultaneously, ensuring timely and accurate delivery of high-quality documents.
Provides detailed medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copy editing and content review.
Ensures document content and style adheres to FDA/EMA or other appropriate regulatory guidelines and complies with departmental SOPs and style guidelines.
Performs literature searches and reviews as necessary to obtain background information and provide literature references.
Provide input on processes, templates, and other business needs within the medical writing function.
Coordinate and/or manage review cycles to triage, incorporate, and resolve team comments, and lead discussion on document revision and finalization for both internally written and outsourced documents.
Serve as a point person for medical writing guidance and document-related problem resolution.
Qualifications
Bachelor's degree in Life Sciences or a related field is required; advanced degree (PhD, PharmD, or MS) strongly preferred.
Minimum of 5 years of medical writing experience in the pharmaceutical, biotechnology, or clinical research industry, with a focus on late-stage clinical development (Phase 3).
Demonstrated experience in writing regulatory submission documents in compliance with regulatory agency guidelines.
Proficiency in Microsoft Office Suite and familiarity with document management systems and version control tools.
Competencies: Attention to Detail, Organizational skills, Adaptability, Multi-Tasking, Strong Written & Verbal Communication skills, Independent Judgement, Cross-Team Collaboration, Critical Thinking, Problem Solving
Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel.
This is a hybrid position located in Xeris' Chicago office and requires three days per week on-site. On-site requirement may change at management's discretion.
The level of the position will be determined based on the selected candidate's qualifications and experience.
#LI-HYBRID
As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors.
The anticipated base salary range for this position is $75,000 to $150,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process.
NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
$75k-150k yearly Auto-Apply 54d ago
IT Service Desk Lead
Xeris Pharmaceuticals 4.2
Xeris Pharmaceuticals job in Chicago, IL
The IT Service Desk Lead is responsible for overseeing daily IT support operations, ensuring efficient service delivery, and driving continuous improvement across the helpdesk function in a Microsoft centric environment. This role serves as a key liaison between end-users and technical teams, ensuring secure, scalable, and premium support for both office and field-based employees.
Responsibilities
Lead daily IT support operations across office and field teams, ensuring timely resolution of issues and minimal business disruption, utilizing ITIL best practices. Serve as the primary escalation point for complex technical problems and high-priority service requests.
Own and evolve ITSM processes (incident, service request, change and problem), document repeatable procedures, and lead support-related projects.
Incident Management - Lead incident response efforts by prioritizing and resolving IT issues swiftly, coordinating with support teams to minimize disruption, meet SLAs, and drive continuous improvement through analysis and reporting.
Service Request Management - Manage and optimize the service request lifecycle, ensuring timely fulfillment, process efficiency, and alignment with ITIL best practices of user requests in alignment to enhance user experience and operational performance.
Change Management - Coordinate and oversee change management activities, ensuring proper assessment, approval, and communication of changes to minimize risk and disruption to IT services.
Problem Management - Drive problem management processes by identifying recurring issues, performing root cause analysis, and implementing long-term solutions to improve service stability and reduce incident volume. Lead and report to management on a regular cadence.
Project Management - Lead support center projects, integrating new technologies and driving successful implementation.
Asset Management - Manage the lifecycle of user-facing technology, maintain accurate asset inventory, and enforce IT security protocols.
Take ownership of support issues, engaging other internal / external expertise as required.
Ability to communicate complex technical information to all stakeholders, including those who do not have a technical background.
Continuously educate employees and equip them with essential IT tools and best practices.
Qualifications
Associate or bachelor's degree in information technology or equivalent work experience preferred
5+ years of progressive experience in IT support/helpdesk roles
Proven supervisory experience with a strong grasp of helpdesk fundamentals-ticketing systems, SLA adherence, and performance metrics; ITIL Foundation knowledge or certification preferred.
Advanced capabilities using Microsoft products including Outlook, Excel, Word, PowerPoint, Teams and SharePoint.
Knowledge of modern workplace technologies, Windows system administration, M365 administration, enterprise backup and recovery, and system performance monitoring tools; agile project management techniques.
Strategic thinker with strong problem-solving abilities, capable of managing multiple priorities under pressure while maintaining attention to detail.
High emotional intelligence and discretion, with a proactive and customer-focused approach to anticipating needs and resolving issues.
Self-starter with initiative and adaptability, thriving in fast-paced, diverse environments and contributing effectively to team success.
Preferred experience with SOX compliance, enterprise desktop management, mobile device management, cybersecurity tools and incident response processes.
Competencies: [Examples may include:] Leadership, Interpersonal Skills, High Emotional Intelligence, Independent Judgement, Teamwork / Collaboration, Verbal & Written Communication, Project Management, Microsoft Office Suite, Attention to Detail, Adaptability
Working Conditions: This is a hybrid position based in Xeris' Chicago office. A minimum of three days per week in the office is required. On-site requirements may change at management's discretion. Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel.
The level of the position will be determined based on the selected candidate's qualifications and experience.
#LI-HYBRID
As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors.
The anticipated base salary range for this position is $75,000 to $110,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process
NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
$75k-110k yearly Auto-Apply 37d ago
Scientist I, Analytical Development
Xeris Pharmaceuticals 4.2
Xeris Pharmaceuticals job in Chicago, IL
The Scientist I, Analytical Development position is responsible for the development and implementation of analytical characterization methods for a range of pharmaceutical dosage forms to support formulation, process, and specification development. This position collaborates with product development scientists in developing therapeutic drug products utilizing the company's proprietary XeriSol and XeriJect platform technologies. This position also supports Quality Control and CMC functions in establishing product specifications, stability programs, material qualification, method validation, method transfer, and process validation.
Responsibilities
Develop and perform specific and selective chromatographic methods (i.e. HPLC, UHPLC, LCMS) for use in characterizing prototype pharmaceutical formulations. Where applicable, methods should be compatible with mass selective/mass spectroscopic detection.
Collaborate with formulation and analytical scientists in the Product Development group to design appropriate stability programs for drug products.
Proficiently configure, operate, and maintain analytical instruments including liquid chromatography systems (HPLC), Karl Fischer titrators, and particle size analyzer.
Keep current with relevant literature and industry standards as applicable to research areas.
Implement analytical procedures according to compendial monographs and standards (USP, EP).
Perform the duties as required for reference standard programs, instrument maintenance and calibration, and drug product stability programs
Collect, analyze, and interpret analytical instrument data while maintaining detailed laboratory records.
Draft Standard Operating Procedures (SOPs) for laboratory equipment operation and maintenance.
Manage external contract laboratories for method development, transfer, and QC testing.
Assume a lead SME role in analytical chemistry related team roles and responsibilities (internal and external projects).
Prepare development reports and contribute to regulatory submissions, including IND and NDA documentation.
Adhere to departmental budgets and spending guidelines.
Qualifications
A Bachelor of Science degree with 3+ years of method development experience in an industrial pharmaceutical laboratory OR
MS / PhD in analytical chemistry with 1+ years of relevant industrial pharmaceutical experience.
Alternatively, a Ph.D. with relevant academic research experience may substitute for some industrial experience.
An appropriate understanding of method development, method validation, and method transfer principles.
Hands-on experience and expertise with HPLC or UHPLC is a must.
Demonstrated understanding of modern chromatographic theory, particularly chromatographic methods focused on Peptides, Proteins and Biologics.
Familiarity with GMP/GLP environments and understanding of FDA and ICH guidelines is a plus.
Ability to work effectively both independently and collaboratively within a team environment.
Prior experience with successful regulatory submissions (IND/NDA/BLA) and commercial method support is a plus.
Developing study protocols and reports with meticulous attention to record accuracy and completeness.
Working knowledge of Microsoft Productivity software (Excel, Word, PowerPoint, etc.) and Agilent OpenLab.
Statistical analysis software such as GraphPad Prism, MiniTab, and JMP is a plus.
Competencies: Teamwork & CollaborationAttention to Detail, Self-Starter, Analytical skills, Problem Solving, Organizational skills, Adaptability, Professionalism, Strong Written and Verbal Communication skills.
Working Conditions:
Must be able to stand for extended periods of time.
Must be able to lift 25 lbs. or more.
Adequate vision (corrected or uncorrected) to read fine instruments such as calipers, instrument displays, etc., and perform visual inspection for defects.
Position works with potentially hazardous chemicals and active pharmaceutical ingredients. May require periodic evening and weekend work as needed to meet program deadlines.
Position may include periodic travel (domestic and international).
This position is based in Xeris' Chicago office and requires five days per week on-site. On-site requirements may change at management's discretion.
The level of the position will be determined based on the selected candidate's qualifications and experience.
#LI-ONSITE
As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors.
The anticipated base salary range for this position is $80,000 - $120,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for commission and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process.
NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
$80k-120k yearly Auto-Apply 4d ago
Senior Financial Analyst
Xeris Pharmaceuticals 4.2
Xeris Pharmaceuticals job in Chicago, IL
The Senior Financial Analyst is a key member of the Finance team responsible for providing financial support and analysis focused on inventory management, manufacturing expense and product cost. This person will be the lead business partner to supply chain, technical operations, and manufacturing to ensure accurate tracking and forecasting of manufacturing costs, inventory balances, and product margins. This role combines strong analytical and financial modeling skills with a solid understanding of biopharmaceutical supply chain and manufacturing dynamics.
Responsibilities
Financial Planning & Forecasting
Lead the annual budgeting and quarterly forecasting processes across commercial and lifecycle management manufacturing teams
Prepare and update detailed expense templates and forecasts; consolidate departmental inputs for review
Collaborate with FP&A leadership to ensure all financial assumptions are accurate and consistent with company objectives
Present financial data to all levels of the organization to highlight important drivers and metrics
Support cash balance projection process through calculation of cash flow impacts related to procurement and production of commercial products
COGS planning & analysis
Support quarterly and annual COGS forecasting processes for commercial products
Develop and maintain cost models to project product gross margins under various volume and pricing scenarios
Analyze actual vs. forecasted manufacturing costs, including material, labor, and overhead variances
Provide insights into COGS trends and drivers for management and investor reporting
Partner with Accounting to lead standard cost setting process leveraging information contained in supplier contracts and production forecasts
Inventory planning & management
Collaborate with Supply Chain and Technical Operations to track and forecast inventory levels across raw materials, WIP, and finished goods
Monitor inventory obsolescence, write-offs, and production yields, providing timely financial impact assessments, including proactive tracking and communication of risks and opportunities
Support monthly close activities by reconciling inventory balances and COGS entries with Accounting and prepare analysis on key variance drivers
Help develop and refine inventory reporting tools to improve visibility and accuracy
Business Partnering
Act as a financial partner to Supply Chain, Manufacturing, and Quality functions.
Support budgeting and expense tracking for internal manufacturing and external contract manufacturing organizations (CMOs).
Assist with financial evaluations of supply agreements, purchase requests, production decisions, and capacity planning initiatives
Modeling & Systems Support
Support the FP&A team in maintaining accurate COGS and inventory components within the corporate financial model
Contribute to process improvements to increase forecasting efficiency and reporting quality, including supporting FP&A system implementation and maintenance
Qualifications
Bachelor's Degree in Finance, Accounting, Supply Chain Management or a related field
3-5 years of experience in FP&A or corporate finance, ideally within pharmaceuticals, biotech, life sciences, or manufacturing
Advanced Excel and financial modeling skills
Familiarity with FP&A systems
Strong analytical, organization, presentation and communication skills
Ability to manage multiple priorities and meet deadlines in a fast-paced environment
Competencies: Methodical, Detail-oriented, Interpersonal skills, Written and Verbal Communication skills, Strategic, Professionalism, Organizational skills, Self-directed, Teamwork, Adaptability
Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel.
This is a hybrid role based in Xeris' Chicago office and requires a minimum of three days per week in the office. On-site requirement may change at management's discretion.
The level of the position will be determined based on the selected candidate's qualifications and experience.
#LI-HYBRID
As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors.
The anticipated base salary range for this position is $75,000 to $100,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process
NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
$75k-100k yearly Auto-Apply 37d ago
Engineer I, Commercial Manufacturing
Xeris Pharmaceuticals 4.2
Xeris Pharmaceuticals job in Chicago, IL
Support all functions of the pharmaceutical supply chain for all commercial products. Ensure product is manufactured in a quality manner under cGMP's and available for sale based on commercial forecasts. Ensure inventory and supplies are available at every point within the supply chain to meet production schedule. The Engineer I will provide a broad understanding of the manufacturing supply chain from drug substance manufacturing through commercial packaging and working within a matrixed organization. The Engineer I / II will assist with planning and execution of routine technical assignments and demonstrates firm understanding of relevant pharmaceutical regulations related to cGMP manufacturing.
Responsibilities
Support manufacturing operations at Contract sites (CMOs, etc.). Responsibilities include, but may not be limited to:
Assist in commercial production planning
Support colleagues in the day-to-day manufacturing activities on a routine basis to ensure commercial supply
Helps with logistics activities such as quotes, invoices, inventory management and shipment of products and intermediates
Frequently interacts with other functional peer group managers and CMOs to support the commercial manufacturing or development activities
Accurately collects / performs data mining and appropriately records / trends observations
Aid in the review of GMP batch records, work instructions, SOPs, deviations, CAPAs, or other required documents for cGMP operations
Collaborate with other functions such as Device Development, Quality Assurance, Quality Control, Regulatory, and Finance
Qualifications
Bachelor's degree required, master's degree preferred in Engineering or relevant Supply Chain, Scientific, or equivalent degree with 3 to 5 years of experience working in pharmaceuticals
Minimum 3 years of experience in a GMP pharmaceutical/biopharmaceutical environment with sterile drug product manufacturing
Must have strong computer skills (including all Microsoft Office), Analytics, Technical Writing, Scheduling, Inventory Management
Skills preferred: Data Management, Manufacturing/Supply Chain background
Competencies: Teamwork & Collaboration, Attention to Detail, Self-Starter, Analytical skills, Problem Solving, Organizational skills, Project Management, Adaptability, Professionalism, Written and Verbal Communications, Presentation skills
Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations. Travel may be required up to 20% at times to CMOs and CSPs location. Periodic overnight travel may occur for work. This position is based in Xeris' Chicago office. A minimum of four days per week on site is required. On site requirement may change at management's discretion.
The level of the position will be determined based on the selected candidate's qualifications and experience.
#LI-HYBRID
As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors.
The anticipated base salary range for this position is $80,000 to $110,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process
NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
$80k-110k yearly Auto-Apply 35d ago
Vice President, Regulatory Affairs
Xeris Pharmaceuticals 4.2
Xeris Pharmaceuticals job in Chicago, IL
The Vice President of Regulatory Affairs will serve as the senior-most regulatory leader responsible for envisioning, developing, and executing the company's global regulatory strategy to support clinical development, product approvals, lifecycle management, and ongoing compliance. The incumbent will lead and grow a high-performing regulatory organization, serve as the primary liaison with regulatory authorities worldwide, and ensure that all corporate activities adhere to applicable regulatory requirements and industry standards. This role requires a strategic yet hands-on leader with deep experience in drug development, submissions, labeling, advertising and promotion, and post-approval compliance.
Responsibilities
Regulatory Leadership & Strategy
• Develop, lead, and operationalize the global regulatory strategy across all development programs and marketed products.
• Provide strategic guidance to executive leadership, program teams, and cross-functional partners on regulatory pathways, risk mitigation, and emerging regulatory trends.
• Oversee the planning and execution of regulatory submissions, including INDs, NDAs, amendments, supplements, and annual reports.
• Guide regulatory decision-making to support clinical trial design, CMC programs, pre/clinical development, and post-marketing activities.
Team Leadership
• Lead, mentor, and retain a high-performing Regulatory Affairs team, including Regulatory Operations, Labeling, and Advertising & Promotion.
• Provide ongoing coaching and feedback to team members.
• Establish departmental goals, operating procedures, and best practices that support scalable growth.
• Foster a collaborative, accountable, and high-integrity culture.
• Ensure regulatory processes and systems are scalable and optimize efficiencies while driving organization compliance.
Regulatory Agency Engagement
• Serve as the primary company liaison with global health authorities (e.g., FDA, EMA, MHRA, PMDA), fostering positive, transparent, and strategic relationships across therapeutic areas, including endocrine disorders, general medicine, and rare diseases.
• Lead the preparation for and participation in meetings with regulatory agencies, including scientific advice meetings, Type A/B/C meetings, pre-IND interactions, and pre-submission meetings for both high-prevalence conditions and orphan indications.
• Drive regulatory strategies tailored to diverse disease landscapes, ensuring alignment with evolving guidelines for common chronic conditions (e.g., diabetes, thyroid disorders) and rare disease programs requiring accelerated pathways (e.g., orphan drug designation, breakthrough therapy).
• Ensure timely, high-quality responses to regulatory inquiries and health authority requests, incorporating complex data packages from large-scale trials in common diseases and innovative designs for small-population rare disease studies.
• Collaborate cross-functionally to integrate regulatory considerations into clinical development plans, balancing standard-of-care expectations for general medicine with unique challenges in rare disease drug development (e.g., natural history studies, surrogate endpoints).
• Provide regulatory leadership for combination products, including coordination of drug-device development strategies, compliance with FDA Combination Product regulations, and alignment of quality and safety requirements across components.
Marketed Product Compliance & Lifecycle Management
• Lead regulatory oversight for marketed products, including post-marketing commitments, label updates, safety reporting, and product changes.
• Ensure continued compliance with regulatory requirements related to labeling, advertising and promotion, product maintenance, and quality systems.
• Partner with Commercial, Medical Affairs, and Quality to support compliant promotional and medical communications activities.
Cross-Functional Collaboration
• Collaborate closely with Clinical Development, CMC, Medical Affairs, and Commercial teams to ensure alignment of regulatory strategy with corporate objectives.
• Provide regulatory insights during portfolio prioritization, business development assessments, and external partnership discussions.
Governance & Compliance
• Ensure adherence to all global regulatory requirements and internal SOPs.
• Maintain awareness of evolving regulatory landscapes and guide the organization in adjusting strategies and processes accordingly.
• Oversee audit readiness and support regulatory inspections as needed.
Qualifications
• Advanced degree in a scientific discipline (PharmD, PhD, MS, or equivalent) required.
• 15+ years of regulatory affairs experience within the pharmaceutical or biotechnology industries.
• Demonstrated success leading global regulatory strategies for products across phases of clinical development and commercialization.
• Proven track record interacting with regulatory agencies and health authorities (e.g., FDA, EMA).
• Experience building and leading regulatory teams during periods of rapid company growth.
Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations and meet submission timelines. Travel up to 25% may be required to accomplish corporate goals and health authority requirements. This is a hybrid position based in Xeris' Chicago office and a minimum of three days per week on-site is required. On-site requirement may change at management's discretion.
NOTE: This is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
#LI-HYBRID
As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors.
The anticipated base salary range for this position is $300,000 to $395,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process
NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
$121k-180k yearly est. Auto-Apply 13d ago
Engineer I, Commercial Manufacturing
Xeris Pharmaceuticals, Inc. 4.2
Xeris Pharmaceuticals, Inc. job in Chicago, IL
Support all functions of the pharmaceutical supply chain for all commercial products. Ensure product is manufactured in a quality manner under cGMP's and available for sale based on commercial forecasts. Ensure inventory and supplies are available at every point within the supply chain to meet production schedule. The Engineer I will provide a broad understanding of the manufacturing supply chain from drug substance manufacturing through commercial packaging and working within a matrixed organization. The Engineer I / II will assist with planning and execution of routine technical assignments and demonstrates firm understanding of relevant pharmaceutical regulations related to cGMP manufacturing.
**Responsibilities**
Support manufacturing operations at Contract sites (CMOs, etc.). Responsibilities include, but may not be limited to:
+ Assist in commercial production planning
+ Support colleagues in the day-to-day manufacturing activities on a routine basis to ensure commercial supply
+ Helps with logistics activities such as quotes, invoices, inventory managementand shipment of products and intermediates
+ Frequently interacts with other functional peer group managers and CMOs to support the commercial manufacturing or development activities
+ Accurately collects / performs data mining and appropriately records / trends observations
+ Aid in the review of GMP batch records, work instructions, SOPs, deviations, CAPAs, or other required documents for cGMP operations
+ Collaborate with other functions such as Device Development, Quality Assurance, Quality Control, Regulatory, and Finance
**Qualifications**
+ Bachelor's degree required, master's degree preferred in Engineering or relevant Supply Chain, Scientific, or equivalent degree with 3 to 5 years of experience working in pharmaceuticals
+ Minimum 3 years of experience in a GMP pharmaceutical/biopharmaceutical environment with sterile drug product manufacturing
+ Must have strong computer skills (including all Microsoft Office), Analytics, Technical Writing, Scheduling, Inventory Management
+ Skills preferred: Data Management, Manufacturing/Supply Chain background
+ Competencies: Teamwork & Collaboration, Attention to Detail, Self-Starter, Analytical skills, Problem Solving, Organizational skills, Project Management, Adaptability, Professionalism, Written and Verbal Communications, Presentation skills
+ Working Conditions:Position may require periodic evening and weekend work, as necessary to fulfill obligations. Travel may be required up to 20% at times to CMOs and CSPs location. Periodic overnight travel may occur for work. This position is based in Xeris' Chicago office. A minimum of four days per week on site is required. On site requirement may change at management's discretion.
_The level of the position will be determined based on the selected candidate's qualifications and experience._
\#LI-HYBRID
_As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors._
_The anticipated base salary range for this position is $80,000 to $110,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process_
_NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization._
**Job Locations** _US-IL-Chicago_
**Title** _Engineer I, Commercial Manufacturing_
**ID** _2025-2307_
**Category** _Technical Operations_
**Type** _Full-Time_
$80k-110k yearly 55d ago
Clinical Project Manager
Xeris Pharmaceuticals 4.2
Xeris Pharmaceuticals job in Chicago, IL
The Clinical Project Manager (CPM) will be responsible for the planning, management and oversight of the operational aspects of clinical trials, including CRO and vendor selection and management/oversight. The CPM ensures that studies are delivered on time, within budget, and in accordance with regulatory requirements, ICH/GCP, and company quality standards. The CPM acts as the central point of contact between cross functional internal teams and external vendors ensuring strategic alignment with program goals and successful trial outcomes. The CPM may also be known as the Clinical Study Manager.
Responsibilities
• Manage and lead the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with study protocols, study specific plans, applicable federal and local regulatory requirements, ICH/GCP guidelines and Xeris SOPs.
• Oversee performance of CROs and clinical service providers to ensure compliance with study protocols and in accordance with scope of work, including setting expectations, training, oversight, managing timelines and deliverables, and issue management.
• Provide input to key study activities, including but not limited to site identification and selection, enrollment projections, clinical supply forecasting, organization of investigator and clinical service provider meetings, data reviews, and Clinical Study Reports.
• Track, collect, and review clinical documentation, such as risk logs, KPIs, monitoring metrics, recruitment performance, issues/actions, etc.
• Collaborate with internal and external stakeholders for the planning and execution of assigned clinical trials. Assist with development and management of project timelines and budgets.
• Review and track vendor invoices and ensure alignment with contracted scope of work.
• Write and/or contribute to the preparation of clinical protocols, amendments, informed consent forms, study plans, case report forms, and other essential study documents.
• Collaborate with legal and finance on the development and management of study specific agreements (i.e. non-disclosure agreements, clinical trial agreements, etc.).
• Oversee clinical study site activities, review and approve monitoring visit reports and site communications, and visit sites as needed.
• Support TMF quality, reconciliation and inspection readiness throughout study lifecycle.
• Contribute to the development and revision of SOPs, processes, forms, templates, tools, etc. with the aim of continual improvement and efficiency.
• Support audits/inspections/inspection readiness activities, including preparation, response, and CAPA development.
• Perform other tasks or responsibilities as assigned.
Qualifications
• Bachelor's degree (BA/BS) or equivalent in life sciences or equivalent.
• 6+ years executing clinical programs required. Global clinical trial experience a plus.
• Experience in endocrinology preferred.
• Experience overseeing CROs and external vendors required.
• Detailed knowledge of ICH/GCP Guidelines and current US FDA regulations.
• Experience with eClinical tools (e.g. eTMF, CTMS, EDC, etc).
• Understanding of clinical study budgets and financial management practices.
• Self-motivated and able to work independently and effectively in a matrix/team environment.
• Ability to handle multiple projects, prioritize work and meet deliverables.
• Ability to proactively problem solve with a solutions-oriented mindset.
• Highly detail-oriented with strong quality and compliance focus.
• Strong computer skills, including a high level of proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, etc.)
• Competencies: Organizational skills, Project Management, Time Management, Functional Leadership, Teamwork & Collaboration, Independent Judgement, Adaptability, Verbal and Written Communication skills
• Working Conditions: If employee is Chicago based - this is a hybrid role based in Xeris' Chicago office and requires a minimum of three days per week in the office. On-site requirements may change at management's discretion. Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel. Travel up to 30%.
The level of the position will be determined based on the selected candidate's qualifications and experience.
#LI-HYBRID
As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors.
The anticipated base salary range for this position is $100,000-170,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process.
NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
$100k-170k yearly Auto-Apply 4d ago
Senior Manager, Reimbursement Access - West
Xeris Pharmaceuticals, Inc. 4.2
Xeris Pharmaceuticals, Inc. job in Chicago, IL
The Senior Manager, Reimbursement Access will play a critical role in ensuring appropriate patient access to Xeris products by leading the Reimbursement Access team, shaping national access strategies, and supporting operational excellence across the function. The incumbent must have deep experience in reimbursement, patient access, and healthcare provider support services, and leadership experience that includes driving the execution of complex operations while developing a high performing team of Reimbursement Access Managers.
**Covers CA, WA, OR, NV, and ID** **including:** Los Angeles, CA: San Diego, CA; San Jose, CA; San Francisco, CA; Seattle, WA; Spokane, WA; Portland, OR; Las Vegas, NV; Coeur d'Alene, ID.
**Responsibilities**
+ **Team Leadership & Talent Development**
+ Identify, recruit, onboard, and develop a high-performing team of Reimbursement Access Managers (RAMs) across key geographies.
+ Provide coaching, mentorship, and performance management to drive effectiveness and professional growth.
+ Lead field-based access teams to execute patient support strategies that improve access and affordability for patients.
+ **Reimbursement Strategy & Execution**
+ Collaborate with Patient Access leadership to design and implement innovative reimbursement access strategies that align with product and company goals.
+ Analyze access barriers and develop field-based solutions to improve access to therapies for rare disease patients.
+ Partner with internal teams (Commercial, Medical Affairs, Legal, Compliance) to ensure alignment and seamless execution of access initiatives.
+ **Operational Excellence**
+ Assist in developing standard operating procedures (SOPs), metrics, and reporting tools to evaluate and optimize the effectiveness of the Reimbursement Access function.
+ Drive continuous improvement initiatives to ensure the highest standards of patient access and compliance.
+ Monitor and assess reimbursement trends, payer coverage, and changes in access environment; provide recommendations to senior leadership.
+ **Stakeholder Engagement**
+ Serve as a strategic liaison between internal stakeholders and field reimbursement teams to ensure market and patient needs are addressed.
+ Provide insights from the field to inform leadership decisions on payer strategy, patient affordability programs, and other access-related initiatives.
+ Represent the company at relevant industry meetings, conferences, and with key external stakeholders as needed.
**Qualifications**
+ Bachelor's degree in business, healthcare, or related field (advanced degree preferred).
+ Minimum of 7 years of experience in market access, reimbursement, patient services, or related pharmaceutical roles.
+ Prior leadership experience managing field reimbursement teams strongly preferred.
+ In-depth understanding of the reimbursement landscape including buy-and-bill, specialty pharmacy, payer dynamics, copay assistance, and HUB services.
+ Experience in rare diseases or specialty biologics/therapies.
+ Demonstrated ability to lead cross-functional initiatives in a fast-paced, entrepreneurial environment.
+ Willingness to travel (up to 30%) to support field teams and stakeholders.
+ Competencies: Leadership, Presentation skills, Written and Verbal Communications, Analytical skills, Problem Solving, Teamwork & Collaboration, Customer Service focus, Adaptability, Professionalism
+ A valid, US state-issued driver's license is required as occasional driving to client locations is a core requirement of this position.
+ Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel.
+ Ability to Travel up to 30%. Travel may include air and ground travel to HCP locations, and company meetings
_The level of the position will be determined based on the selected candidate's qualifications and experience._
\#LI-REMOTE
_As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors._
_The anticipated base salary range for this position is $130,000 to $220,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for commission and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process._
_NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization._
**Job Locations** _US_
**Title** _Senior Manager, Reimbursement Access - West_
**ID** _2025-2168_
**Category** _Market Access_
**Type** _Full-Time_
$130k-220k yearly 60d+ ago
Director, Market Access
Xeris Pharmaceuticals, Inc. 4.2
Xeris Pharmaceuticals, Inc. job in Chicago, IL
The Director, Market Access is responsible for leading strategies and initiatives that expand patient access to Xeris' therapies, optimize reimbursement, and strengthen partnerships across the healthcare ecosystem. This role will design and implement market access programs, collaborate with cross-functional leaders, and manage key customer relationships to support Xeris' commercial growth objectives.
**Responsibilities**
- Build and maintain relationships with U.S Payers, trade accounts, wholesalers, and Specialty pharmacies.
- Develop strategic plans to optimize formulary placement. This involves analyzing market trends, understanding payer dynamics, and leveraging clinical data to make compelling cases for inclusion or reduction of controls.
- Structure rebate contracts that align with clinical efficacy and patient outcomes. This ensures that financial incentives support, rather than compromise, access to optimal therapies.
- Collaborate cross-functionally with Contracts & Pricing, Sales, Marketing, Medical Affairs, Regulatory Affairs, and Finance to support access, affordability, and distribution objectives.
- Create innovative programs to engage stakeholders and optimize distribution channels.
- Oversee development of payer value propositions, formulary submissions, and coverage tools.
- Monitor payer, reimbursement, and distribution trends; communicate insights and recommendations to senior leadership.
- Develop reporting procedures to track program effectiveness, ROI, and compliance.
- Lead and Manage Market Access and Trade team members to ensure alignment with corporate strategy.
**Qualifications**
- Bachelor's degree required; advanced degree (MBA, MPH, PharmD) preferred.
- 8-10 years of progressive experience in Market Access or Payer Accounts within the biopharmaceutical industry.
- Proven track record of successfully developing and implementing payer and trade strategies.
- Strong knowledge of U.S. pharmaceutical distribution, payer systems, reimbursement models, and compliance requirements.
- Demonstrated ability to lead teams, manage key customer relationships, and deliver results in a complex, cross-functional environment.
- Excellent communication, negotiation, and presentation skills.
- Ability to analyze data, interpret market trends, and provide actionable insights to leadership.
-Competencies: Strategic Leadership, Adaptability, Cross-Functional relationships, Written and Verbal Communications, Presentation skills, Customer Service focus, Teamwork & Collaboration, Attention to Detail, Self-Starter, Professionalism.
-Working Conditions: Position may require periodic evening and weekend work to meet business need. Up to 20% domestic travel.
_The level of the position will be determined based on the selected candidate's qualifications and experience._
\#LI-REMOTE
_As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors._
_The anticipated base salary range for this position is $190,000 to $270,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for commission and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process._
_NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization._
**Job Locations** _US_
**Title** _Director, Market Access_
**ID** _2026-2328_
**Category** _Market Access_
**Type** _Full-Time_
$69k-111k yearly est. 4d ago
Associate Director, Biostatistics and Statistical Programming
Xeris Pharmaceuticals, Inc. 4.2
Xeris Pharmaceuticals, Inc. job in Chicago, IL
The Associate Director, Biostatistics and Statistical Programming will drive biostatistical activities, performed primarily by vendors, in support of project timelines and budgets related to drug product development at Xeris. The individual will contribute to study design, protocol development, case report form development, clinical study reports, and exhibits for other reports and presentations.
**Responsibilities**
+ Conducts basic statistical analysis of study datawith minimal supervision according to a statistical analysis planto generate results and insights used to support study findings.
+ Applies moderately advanced statistical methods, which may include simulation models and other statistical programming as needed, with guidance.
+ Generates sample size and power calculations and randomizations.
+ Oversees the review of statistical documents and operational activities outsourced to CROs ensuring adherence to cost, timeline, and data quality requirements to ensure that the analysis plans use the most appropriate statistical methods and that the data displays such as tables/figures/listings are accurate and complete.
+ Programs or independently validates key study results to support interpretation of data.
+ Provides statistical programming support to other clinical studies or regulatory submissions where another biostatistician is assigned as the sponsor lead.
+ Works closely with Data Management by providing input to data management-related documents and assisting with data review and cleaning activities, as needed.
+ Ensures compliance of data packages to regulatory requirements and CDISC and industry standards.
+ Assists in the development of abstracts, manuscripts, presentations for scientific congresses.
+ Closely collaborates and participates in knowledge sharing with other team members including non-statisticiansto assist with interpretation and understanding of results.
**Qualifications**
+ MS/MPH degree in biostatistics, statistics, or epidemiology
+ A minimum of six years of clinical trial experience as a statistician and/or statistical programmer in the pharmaceutical, biotech, or CRO industry
+ Experience in Phases I-III of the clinical drug development process
+ Knowledge and basic understanding of statistical concepts and techniques commonly applied to the analysis of data from clinical trials and the ability to tackle from basic to moderately complex statistical or data issues
+ Basic understanding of real-world data and observational studies.
+ SAS programming experience required, R experience is a plus
+ Working knowledge of CDISC standards
+ Prior use and implementation of sample size and power calculation software (e.g., nQuery and PASS) preferred
+ Working knowledge of EDC systems
+ Competencies: Attention to Detail, Organizational skills, Adaptability, Multi-Tasking, Strong Written & Verbal Communication skills, Teamwork & Collaboration, Critical Thinking, Problem Solving, Presentation Skills
+ Working Conditions: This is a hybrid position based in Xeris' Chicago office. A minimum of three days per week on-site is required. On-site requirement may change at management's discretion.Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel.
_The level of the position will be determined based on the selected candidate's qualifications and experience._
\#LI-HYBRID
_As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors._
_The anticipated base salary range for this position is $140,000 to $240,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process_
_NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization._
**Job Locations** _US-IL-Chicago_
**Title** _Associate Director, Biostatistics and Statistical Programming_
**ID** _2025-2295_
**Category** _Clinical Development_
**Type** _Full-Time_
$140k-240k yearly 60d+ ago
Medical Writer
Xeris Pharmaceuticals, Inc. 4.2
Xeris Pharmaceuticals, Inc. job in Chicago, IL
Reporting directly to the Vice President of Clinical Development, the Medical Writer will be responsible for leading and executing all medical writing activities supporting Xeris' clinical programs. The individual will have a strong scientific background, exceptional writing skills, and a proven ability to translate complex clinical and scientific data into clear, accurate, and regulatory-compliant documents tailored to diverse audiences.
**Responsibilities**
+ Develop and authora broad range of clinical and regulatory documents, including but not limited to: clinical study protocols, investigator brochures (IBs), clinical study reports (CSRs), and sections of regulatory submissions (e.g., IND, NDA, etc.).
+ Ensure accuracy, clarity, consistency, and compliancewith internal standards, applicable regulatory guidelines (e.g., ICH, FDA, EMA), and company SOPs.
+ Collaborate cross-functionallywith colleagues in Clinical, Regulatory Affairs, Medical Affairs, and other internal stakeholders to gather relevant data and ensure consistency of messaging across documents.
+ Translate highly technical and statistical informationinto clear, concise content suitable for a wide variety of audiences including regulators, healthcare professionals, and non-scientific business leaders, as required.
+ Contribute to the development of communication materials, including slide decks, manuscripts, abstracts, and presentations, to support internal and external scientific communications.
+ Maintain document quality controlthrough proofreading, editing, and adherence to templates, style guides, and version control procedures.
+ Manage timelines and priorities for multiple projects simultaneously, ensuring timely and accurate delivery of high-quality documents.
+ Provides detailed medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copy editing and content review.
+ Ensures document content and style adheres to FDA/EMA or other appropriate regulatory guidelines and complies with departmental SOPs and style guidelines.
+ Performs literature searches and reviews as necessary to obtain background information and provide literature references.
+ Provide input on processes, templates, and other business needs within the medical writing function.
+ Coordinate and/or manage review cycles to triage, incorporate, and resolve team comments, and lead discussion on document revision and finalization for both internally written and outsourced documents.
+ Serve as a point person for medical writing guidance and document-related problem resolution.
**Qualifications**
+ Bachelor's degree in Life Sciences or a related field is required; advanced degree (PhD, PharmD, or MS) strongly preferred.
+ Minimum of 5 years of medical writing experience in the pharmaceutical, biotechnology, or clinical research industry, with a focus on late-stage clinical development (Phase 3).
+ Demonstrated experience in writing regulatory submission documents in compliance with regulatory agency guidelines.
+ Proficiency in Microsoft Office Suite and familiarity with document management systems and version control tools.
+ Competencies: Attention to Detail, Organizational skills, Adaptability, Multi-Tasking, Strong Written & Verbal Communication skills, Independent Judgement, Cross-Team Collaboration, Critical Thinking, Problem Solving
+ Working Conditions:Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel. _This is a hybrid position located in Xeris' Chicago office and requires three days per week on-site. On-site requirement may change at management's discretion._
_The level of the position will be determined based on the selected candidate's qualifications and experience._
\#LI-HYBRID
_As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors._
_The anticipated base salary range for this position is $75,000 to $150,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process._
_NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization._
**Job Locations** _US-IL-Chicago_
**Title** _Medical Writer_
**ID** _2025-2296_
**Category** _Clinical Development_
**Type** _Full-Time_
$75k-150k yearly 60d+ ago
IT Service Desk Lead
Xeris Pharmaceuticals, Inc. 4.2
Xeris Pharmaceuticals, Inc. job in Chicago, IL
The IT Service Desk Lead is responsible for overseeing daily IT support operations, ensuring efficient service delivery, and driving continuous improvement across the helpdesk function in a Microsoft centric environment. This role serves as a key liaison between end-users and technical teams, ensuring secure, scalable, and premium support for both office and field-based employees.
**Responsibilities**
+ Lead daily IT support operations across office and field teams, ensuring timely resolution of issues and minimal business disruption, utilizing ITIL best practices. Serve as the primary escalation point for complex technical problems and high-priority service requests.
+ Own and evolve ITSM processes (incident, service request, change and problem), document repeatable procedures, and lead support-related projects.
+ Incident Management - Lead incident response efforts by prioritizing and resolving IT issues swiftly, coordinating with support teams to minimize disruption, meet SLAs, and drive continuous improvement through analysis and reporting.
+ Service Request Management - Manage and optimize the service request lifecycle, ensuring timely fulfillment, process efficiency, and alignment with ITIL best practices of user requests in alignment to enhance user experience and operational performance.
+ Change Management - Coordinate and oversee change management activities, ensuring proper assessment, approval, and communication of changes to minimize risk and disruption to IT services.
+ Problem Management - Drive problem management processes by identifying recurring issues, performing root cause analysis, and implementing long-term solutions to improve service stability and reduce incident volume. Lead and report to management on a regular cadence.
+ Project Management - Lead support center projects, integrating new technologies and driving successful implementation.
+ Asset Management - Manage the lifecycle of user-facing technology, maintain accurate asset inventory, and enforce IT security protocols.
+ Take ownership of support issues, engaging other internal / external expertise as required.
+ Ability to communicate complex technical information to all stakeholders, including those who do not have a technical background.
+ Continuously educate employees and equip them with essential IT tools and best practices.
**Qualifications**
+ Associate or bachelor's degree in information technology or equivalent work experience preferred
+ 5+ years of progressive experience in IT support/helpdesk roles
+ Proven supervisory experience with a strong grasp of helpdesk fundamentals-ticketing systems, SLA adherence, and performance metrics; ITIL Foundation knowledge or certification preferred.
+ Advanced capabilities using Microsoft products including Outlook, Excel, Word, PowerPoint, Teams and SharePoint.
+ Knowledge of modern workplace technologies, Windows system administration, M365 administration, enterprise backup and recovery, and system performance monitoring tools; agile project management techniques.
+ Strategic thinker with strong problem-solving abilities, capable of managing multiple priorities under pressure while maintaining attention to detail.
+ High emotional intelligence and discretion, with a proactive and customer-focused approach to anticipating needs and resolving issues.
+ Self-starter with initiative and adaptability, thriving in fast-paced, diverse environments and contributing effectively to team success.
+ Preferredexperience with SOX compliance, enterprise desktop management, mobile device management, cybersecurity tools and incident response processes.
+ Competencies: [Examples may include:] Leadership, Interpersonal Skills, High Emotional Intelligence, Independent Judgement, Teamwork / Collaboration, Verbal & Written Communication, Project Management, Microsoft Office Suite, Attention to Detail, Adaptability
+ Working Conditions: This is a hybrid position based in Xeris' Chicago office. A minimum of three days per week in the office is required. On-site requirements may change at management's discretion.Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel.
_The level of the position will be determined based on the selected candidate's qualifications and experience._
\#LI-HYBRID
_As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors._
_The anticipated base salary range for this position is $75,000 to $110,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process_
_NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization._
**Job Locations** _US-IL-Chicago_
**Title** _IT Service Desk Lead_
**ID** _2025-2300_
**Category** _IT_
**Type** _Full-Time_
$75k-110k yearly 60d+ ago
Scientist I, Analytical Development
Xeris Pharmaceuticals, Inc. 4.2
Xeris Pharmaceuticals, Inc. job in Chicago, IL
The Scientist I, Analytical Development position is responsible for the development and implementation of analytical characterization methods for a range of pharmaceutical dosage forms to support formulation, process, and specification development. This position collaborates with product development scientists in developing therapeutic drug products utilizing the company's proprietary XeriSol and XeriJect platform technologies. This position also supports Quality Control and CMC functions in establishing product specifications, stability programs, material qualification, method validation, method transfer, and process validation.
**Responsibilities**
+ Develop and perform specific and selective chromatographic methods (i.e. HPLC, UHPLC, LCMS) for use in characterizing prototype pharmaceutical formulations. Where applicable, methods should be compatible with mass selective/mass spectroscopic detection.
+ Collaborate with formulation and analytical scientists in the Product Development group to design appropriate stability programs for drug products.
+ Proficiently configure, operate, and maintain analytical instruments including liquid chromatography systems (HPLC), Karl Fischer titrators, and particle size analyzer.
+ Keep current with relevant literature and industry standards as applicable to research areas.
+ Implement analytical procedures according to compendial monographs and standards (USP, EP).
+ Perform the duties as required for reference standard programs, instrument maintenance and calibration, and drug product stability programs
+ Collect, analyze, and interpret analytical instrument data while maintaining detailed laboratory records.
+ Draft Standard Operating Procedures (SOPs) for laboratory equipment operation and maintenance.
+ Manage external contract laboratories for method development, transfer, and QC testing.
+ Assume a lead SME role in analytical chemistry related team roles and responsibilities (internal and external projects).
+ Prepare development reports and contribute to regulatory submissions, including IND and NDA documentation.
+ Adhere to departmental budgets and spending guidelines.
**Qualifications**
+ A Bachelor of Science degree with 3+ years of method development experience in an industrial pharmaceutical laboratory OR
+ MS / PhD in analytical chemistry with 1+ years of relevant industrial pharmaceutical experience.
+ Alternatively, a Ph.D. with relevant academic research experience may substitute for some industrial experience.
+ An appropriate understanding of method development, method validation, and method transfer principles.
+ Hands-on experience and expertise with HPLC or UHPLC is a must.
+ Demonstrated understanding of modern chromatographic theory, particularly chromatographic methods focused on Peptides, Proteins and Biologics.
+ Familiarity with GMP/GLP environments and understanding of FDA and ICH guidelines is a plus.
+ Ability to work effectively both independently and collaboratively within a team environment.
+ Prior experience with successful regulatory submissions (IND/NDA/BLA) and commercial method support is a plus.
+ Developing study protocols and reports with meticulous attention to record accuracy and completeness.
+ Working knowledge of Microsoft Productivity software (Excel, Word, PowerPoint, etc.) and Agilent OpenLab.
+ Statistical analysis software such as GraphPad Prism, MiniTab, and JMP is a plus.
+ Competencies: Teamwork & CollaborationAttention to Detail, Self-Starter, Analytical skills, Problem Solving, Organizational skills, Adaptability, Professionalism, Strong Written and Verbal Communication skills.
+ Working Conditions:
+ Must be able to stand for extended periods of time.
+ Must be able to lift 25 lbs. or more.
+ Adequate vision (corrected or uncorrected) to read fine instruments such as calipers, instrument displays, etc., and perform visual inspection for defects.
+ Position works with potentially hazardous chemicals and active pharmaceutical ingredients. May require periodic evening and weekend work as needed to meet program deadlines.
+ Position may include periodic travel (domestic and international).
+ _This position is based in Xeris' Chicago office and requires five days per week on-site. On-site requirements may change at management's discretion._
_The level of the position will be determined based on the selected candidate's qualifications and experience._
\#LI-ONSITE
_As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors._
_The anticipated base salary range for this position is $80,000 - $120,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for commission and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process._
_NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization._
**Job Locations** _US-IL-Chicago_
**Title** _Scientist I, Analytical Development_
**ID** _2025-2314_
**Category** _Product Development_
**Type** _Full-Time_
$80k-120k yearly 48d ago
Senior Financial Analyst
Xeris Pharmaceuticals, Inc. 4.2
Xeris Pharmaceuticals, Inc. job in Chicago, IL
The Senior Financial Analyst is a key member of the Finance team responsible for providing financial support and analysis focused on inventory management, manufacturing expense and product cost. This person will be the lead business partner to supply chain, technical operations, and manufacturing to ensure accurate tracking and forecasting of manufacturing costs, inventory balances, and product margins. This role combines strong analytical and financial modeling skills with a solid understanding of biopharmaceutical supply chain and manufacturing dynamics.
**Responsibilities**
+ Financial Planning & Forecasting
+ Lead the annual budgeting and quarterly forecasting processes across commercial and lifecycle management manufacturing teams
+ Prepare and update detailed expense templates and forecasts; consolidate departmental inputs for review
+ Collaborate with FP&A leadership to ensure all financial assumptions are accurate and consistent with company objectives
+ Present financial data to all levels of the organization to highlight important drivers and metrics
+ Support cash balance projection process through calculation of cash flow impacts related to procurement and production of commercial products
+ COGS planning & analysis
+ Support quarterly and annual COGS forecasting processes for commercial products
+ Develop and maintain cost models to project product gross margins under various volume and pricing scenarios
+ Analyze actual vs. forecasted manufacturing costs, including material, labor, and overhead variances
+ Provide insights into COGS trends and drivers for management and investor reporting
+ Partner with Accounting to lead standard cost setting process leveraging information contained in supplier contracts and production forecasts
+ Inventory planning & management
+ Collaborate with Supply Chain and Technical Operations to track and forecast inventory levels across raw materials, WIP, and finished goods
+ Monitor inventory obsolescence, write-offs, and production yields, providing timely financial impact assessments, including proactive tracking and communication of risks and opportunities
+ Support monthly close activities by reconciling inventory balances and COGS entries with Accounting and prepare analysis on key variance drivers
+ Help develop and refine inventory reporting tools to improve visibility and accuracy
+ Business Partnering
+ Act as a financial partner to Supply Chain, Manufacturing, and Quality functions.
+ Support budgeting and expense tracking for internal manufacturing and external contract manufacturing organizations (CMOs).
+ Assist with financial evaluations of supply agreements, purchase requests, production decisions, and capacity planning initiatives
+ Modeling & Systems Support
+ Support the FP&A team in maintaining accurate COGS and inventory components within the corporate financial model
+ Contribute to process improvements to increase forecasting efficiency and reporting quality, including supporting FP&A system implementation and maintenance
**Qualifications**
+ Bachelor's Degree in Finance, Accounting, Supply Chain Management or a related field
+ 3-5 years of experience in FP&A or corporate finance, ideally within pharmaceuticals, biotech, life sciences, or manufacturing
+ Advanced Excel and financial modeling skills
+ Familiarity with FP&A systems
+ Strong analytical, organization, presentation and communication skills
+ Ability to manage multiple priorities and meet deadlines in a fast-paced environment
+ Competencies: Methodical, Detail-oriented, Interpersonal skills, Written and Verbal Communication skills, Strategic, Professionalism, Organizational skills, Self-directed, Teamwork, Adaptability
+ Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel. _This is a hybrid role based in Xeris' Chicago office and requires a minimum of three days per week in the office. On-site requirement may change at management's discretion._
_The level of the position will be determined based on the selected candidate's qualifications and experience._
\#LI-HYBRID
_As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors._
_The anticipated base salary range for this position is $75,000 to $100,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process_
_NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization._
**Job Locations** _US-IL-Chicago_
**Title** _Senior Financial Analyst_
**ID** _2025-2313_
**Category** _Finance_
**Type** _Full-Time_
$75k-100k yearly 48d ago
Director, Formulation Development
Xeris Pharmaceuticals 4.2
Xeris Pharmaceuticals job in Chicago, IL
Xeris is seeking an experienced Director of Formulation Development to lead and manage a team developing innovative dosage forms and drug delivery systems. Reporting to the Sr. Director, Formulation Development, this role will provide strategic and technical leadership across formulation activities while also directing complex projects that are critical to advancing the company's product pipeline. As an expert in the areas of preformulation and formulation development studies, drug delivery technologies, and product development, this position will be responsible for providing guidance, oversight, and mentoring to a team of scientists. This role will anticipate potential developmental challenges and implement mitigation strategies to reduce program risk.
Responsibilities
Lead and manage a team of scientists in the development and execution of complex formulation projects for injectable small molecules, peptides, and proteins using Xeris' novel proprietary formulation platforms.
Provide strategic direction and guidance to the formulation development team on all aspects of injectable small molecule, peptide, and protein formulations, including process development, characterization, scale-up, tech transfer and manufacturing support.
Lead high throughput screening of excipients, selection of primary drug container closure systems, identification of degradation pathways, and development of stable formulations.
Lead the development and implementation of novel formulation strategies for injectable products, including long-acting formulations, sustained release formulations, and targeted delivery systems.
Demonstrate a thorough understanding of relevant technical/scientific literature, standard procedures, and pharmaceutical regulations relevant to the programs.
Develop and implement innovative methods for characterization and stability testing of injectable biologics.
Drive the development of robust and scalable manufacturing processes for injectable products.
Identify and mitigate technical risks associated with formulation development and manufacturing. Anticipate manufacturability challenges associated with parenteral drug product development.
Develop and manage project budgets and timelines, ensuring efficient and on-time completion of projects.
Communicate effectively with cross-functional teams (e.g., R&D, Regulatory, Manufacturing) to ensure seamless product development.
Provide guidance on quality aspects across regulatory filings related to specifications, acceptance criteria, and stability protocols.
Cultivate partnerships by serving as lead point of contact with contract manufacturing organizations and external collaborators.
Ensure compliance with all relevant regulatory requirements for injectable products, including ICH guidelines and FDA regulations.
Contribute to the preparation and submission of regulatory documentation, including INDs, NDAs, and BLAs.
Provide expert technical support during regulatory inspections and audits.
Build a high performing team through mentoring, goal setting, and supporting the continuing education of junior staff.
Contribute to the development of internal training programs and seminars related to formulation science and technology.
Write and review study protocols and reports (both formal and informal) to support product development studies and regulatory filings.
Stay current with the latest scientific literature and present findings at industry conferences and events.
Identify and evaluate emerging technologies and trends in the field of injectable formulation development.
Develop and implement strategic initiatives to improve the efficiency and effectiveness of the formulation development process.
Qualifications
Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering or related discipline.
A minimum of 10 years in pharmaceutical development, with increasing management responsibility.
Familiarity with regulatory requirements for pharmaceutical development.
Passion for innovation and scientific discovery, developing junior staff, and advancing healthcare through novel medicines.
Knowledge and proficiency using experimental design and statistical analysis software (e.g., JMP / MiniTab / GraphPad Prism).
Competencies: Attention to Detail, Independent Judgement, Teamwork & Collaboration, Self-Starter, Adaptability, Professionalism, Written & Verbal Communication skills, Functional Leadership, Problem-Solving skills, Project Management skills.
Working Conditions:
Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel.
Must be able to stand for extended periods of time. Must be able to lift 25 lbs. or more.
Adequate vision (corrected or uncorrected) to read fine instruments such as instrument displays, etc., and perform visual inspection for defects.
This position is based in Xeris' Chicago office and requires five days per week on-site to ensure oversight and leadership of the laboratory team.
Position works with potentially hazardous chemicals and active pharmaceutical ingredients.
Domestic and/or international travel up to 10% may be required.
The level of the position will be determined based on the selected candidate's qualifications and experience.
#LI-ONSITE
As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors.
The anticipated base salary range for this position is $175,000 - $250,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for commission and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process.
NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
$74k-119k yearly est. Auto-Apply 60d+ ago
Sr. Director, Commercial Analytics and Reporting (Chicago based)
Xeris Pharmaceuticals 4.2
Xeris Pharmaceuticals job in Chicago, IL
The Senior Director, Commercial Analytics and Reporting serves as the strategic leader for commercial analytics capability, setting vision, direction, and standards for enterprise data-driven decision making across all Commercial functions. This role works across the organization to influence leaders on opportunities to drive revenue through promotional efforts and or analytical insights to support key strategic decisions. The incumbent will design, execute, interpret, and communicate actionable analytics to support commercial decision-making across Xeris' rare and retail product franchises. This role is critical to driving data-informed strategies and maximizing the performance of Xeris' commercial initiatives during a pivotal phase of company growth.
Responsibilities
Development of analytics-based market insights and business intelligence to inform optimal strategic brand/portfolio decision-making, and measure brand performance
Develop and maintain commercial analytics dashboards, reports, and key performance indicators (KPIs) to monitor brand and market performance across rare disease and retail product portfolios
Conduct deep-dive analyses on sales, CareConnect, promotional, and market access data to identify opportunities and performance drivers
Collaborate with leadership to develop reports efficiently and effectively to meet information needs of Patient Services, Sales, Marketing, and other key business partners
Design and deploy dashboards to track defined KPIs for Patient Assistance Team (PAMs and RAMS) and promotional activity
Partner with cross-functional teams (e.g., Marketing, Market Access, Sales, Medical Affairs, Finance) to align on business questions and translate them into structured analytics deliverables
Support the development of forecast assumptions through data analysis and triangulation of primary/secondary insights
Leverage syndicated data (e.g., IQVIA, claims data) and internal data assets to develop a holistic understanding of market dynamics and brand performance
Develop, format, publish and maintain Excel workbooks and related SQL scripts for patient services and Sales Reporting
Provide advanced analytic support for performance tracking, targeting/segmentation, launch readiness, and field force effectiveness
Translate complex analyses into clear, concise visual presentations and strategic recommendations for senior leadership and brand stakeholders
Proactively identify emerging trends, performance risks, or growth opportunities through regular business reviews
Marketing Analytics, Campaign Measurement & Omni-channel measurements of reach, engagement, and impact of marketing campaigns across all channels and touchpoints
Lead Marketing Mix Modeling (MMM) initiatives to quantify marketing ROI and optimize media investment allocation across traditional and digital channels Collaborate with marketing to build and enhance customer journey mappings by segment capabilities across personal and non-personal channels
Leverage insights from analytics to design and activate automated omnichannel campaigns that optimize engagement timing, channel selection and impact with patients and healthcare providers
Collaborate with external vendors and consultants, as needed, to enhance analytic capabilities or fulfill specialized project needs
Manage business rules used to issue product alerts based on claims data
Respond to and develop solutions for questions related to sales and patient data or reporting
Assist in conducting HCP, patient, and payer primary Market Research projects
Qualifications
Bachelor's degree in advanced Analytics, Statistics, Finance or related quantitative field management Science - advanced degree preferred
Minimum of 12-15 years of experience in analysis and modeling including demonstrated experience within the healthcare industry (pharmaceutical/specialty pharma/biotech/device)
Rare disease and/or biotech industry experience preferred
Experience with specialty pharmacy claims and data operations
Self-starter who anticipates challenges, identifies opportunities, and provides creative solutions
Key data platforms used, IQVIA, Veeva, Power BI, various pharmacy and claims datasets and other third-party data as identified.
Demonstrated experience with Salesforce CRM platform, including an understanding of basic development and system capabilities
Strong knowledge of the healthcare landscape, market access, and performance related to experience with reporting tools (SQL, Tableau, etc.)
Ability to develop and drive forecasting models appropriate to market and product life cycle
Competencies: Cross-functional Leadership, Attention to Detail, Analytical skills Results-Oriented, Independent Judgement, Teamwork/Collaboration, Intellectual Curiosity, Interpersonal skills, Written and Verbal Communication skills
Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel.
This is a hybrid position based in Xeris' Chicago office. A minimum of three days per week on-site is required. On-site requirement may change at management's discretion.
The level of the position will be determined based on the selected candidate's qualifications and experience.
#LI-HYBRID
As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors.
The anticipated base salary range for this position is $210,000 to $270,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process
NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.