Our Culture
Any business will have its days of dealing with the unknown: factors change, people must pivot, schedules don’t always go as planned. The question of culture becomes how people working together respond and adapt in the face of change, unpredictability and even adversity.
Xentria is a group of professionals with diverse talents yet similar minds in overcoming challenges. Achievement calls for swimming with the tide of transition rather than against it. We complete projects and goals by maintaining equal parts structure and flexibility in pursuing the desired outcome for patients. We also know and embrace that progress remains closer when team members are friendly, responsive and accessible to one another.
At Xentria, we can’t promise that one day will be just like the next – but we can ensure that whatever tomorrow brings, we’ll share the challenges and triumphs alike as a team.
Diversity & Inclusion
Located in the new Lincoln Yards development in Chicago, Xentria, Inc. is a biotech company focused on solving unmet clinical needs through meaningful patient engagement and novel scientific strategy.
We promote a culture of innovation, collaboration, inclusion and compassion. At all levels of the company, we are working to advance our diversity, equity, inclusion and accessibility (DEIA) practices.
This starts with company-wide DEIA learning and education and continues with encouraging an inclusive environment. We value diverse perspectives, experience and ideas and continually review our policies and procedures to ensure fair treatment of our employees, our patients and our community.
Corporate Responsibility
We are committed to developing therapeutics that will solve unmet patient needs. We strive to do this in a sustainable way by establishing a value-based culture with a focus on our people and our community. We know that our people are our greatest assets, and we are proud to support their involvement in community initiatives and volunteering.
Equal Opportunity
Xentria, Inc. is committed to equal employment for all. In line with that commitment, Xentria provides equal employment opportunities to all employees and applicants without regard to race, color, religion, national origin, sex, age, disability and all other protections.
We strictly prohibit the harassment or discrimination of any employee or job candidate on the basis of race, color, religion, national origin, sex, age, disability or any other protected classes. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits and training. We make hiring decisions based solely on qualifications, merit and current business requirements.
Our Benefits
We strive to offer a robust benefits program that meets the needs of each of our team members.
We Offer:
competitive wages
flexible work arrangements
annual performance-bonus opportunity
short and long-term disability
extensive health offerings including medical, dental, vision
paid time off (PTO)
401(k) retirement savings with employer contribution
paid parental leave
employee wellness resources
(11) company-paid holidays
life and AD&D insurance
onsite gym membership
Each person here brings a strong sense of purpose and their own journey through clinical research into our day-to-day operations which makes for a dynamic and dedicated group.
I find purpose in working on clinical programs that work to fill an unmet need, and fostering an agile and entrepreneurial team of amazing individuals!
At Xentria, the pursuit of addressing the unmet needs of patients brings me a deep sense of purpose. I am driven by the opportunity to make a meaningful impact on the lives of patients, utilizing my skills and expertise to contribute to their well-being and the advancement of healthcare.
Upon starting at Xentria, I immediately felt a sense of belonging. The Xentria community nurtures this sense of belonging by recognizing and appreciating team members' efforts and by promoting a positive work environment. With this strong emphasis on community, my work life at Xentria is both fulfilling and rewarding.
Xentria fosters a sense of community by creating an environment where everyone feels supported and valued. This motivating environment not only drives our collective success but also makes every contribution feel significant and impactful!
The culture here is one of support and empowerment with a focus on employee life balance. Xentria values each and every employee and that is evident in all aspects of the business, from extensive benefit offerings to opportunities for both personal and professional development. Xentria truly cares about its employees as individuals and supports us in our endeavors in the office and in the community.
At Xentria, I get to work with really smart people who are experts in clinical research. I learn from them every day. But beyond the collective knowledge and creativity, I love the collaborative spirit at Xentria. Every role on the team is respected and every person is valued and encouraged to do their best work.
Job Openings
12/3/2024
Director of Clinical Quality Assurance (GCP)
Summary
Xentria is committed to advancing drug development through meaningful patient engagement and effective partnerships and has a track record of success in securing key collaborations in the life sciences industry. The team at Xentria is dedicated to helping early-stage products advance to the next stage of clinical development, getting them one step closer to commercial launch. Established in 2020 and headquartered in Chicago, Xentria collaborates closely with academic researchers, patient communities and biotechs as we commit to embracing the complexities of co-development projects. Our lead asset, XT MAB 16, is a monoclonal antibody, received Orphan Drug Designation by the FDA and EMA and is current in development for the rare disease of sarcoidosis.
Xentria is seeking an experienced Director of Clinical Quality Assurance to join their Quality Assurance team. This candidate will report directly to the Vice President of Quality Assurance. The Director of Clinical Quality Assurance will provide strong leadership and clinical development experience to support Xentria’s Quality Assurance and clinical compliance programs. This role will involve ongoing interaction with internal project team members, vendors, partners and project teams, influencing these internal and external stakeholders to successfully embed a robust Quality Assurance culture. This is a high-visibility role and will be directly involved in developing and continuously improving Quality Management System at Xentria. Director of Clinical Quality Assurance will be relied upon as a subject matter expert in GCP and Clinical Compliance with respect to the planning, execution, and close-out of clinical studies.
Essential Duties and Responsibilities
Essential Duties and Responsibilities include the following. Other duties may be assigned.
Quality Systems:
• Participate in the establishment, maintenance and improvement the Quality Management System and associated practices.
• Execute and oversee the clinical development oversight program across Clinical Development and implement quality throughout clinical trial execution.
• Determines, evaluates and investigates GCP Quality Events and determines adequacy of reporting and the potential impact on the study.
• Participate in inspections performed by FDA and international regulatory agencies; also, audits performed by partners.
• Proactively identify analyses and leverage quality indicators and data to identify potential trends and risks to address and complete risk-based QA assessments and to support the implementation of associated risk mitigation strategies.
• Assists in developing a robust clinical (GCP) quality system, provides business-level leadership, fosters best practices, and mentors and consults on compliance techniques across the development and operations organizations
• Deliver input (e.g., GCP) on relevant projects to the Functional Areas and Quality Management Review
• Process Deviations, Quality Issues, CAPAs, and changes as required in the clinical studies.
• Develop and support the issuance of Controlled Documents (e.g., Policy, SOPs, KPIs)
• Support and manage computer system validation activities for GXP-related systems
• Provide suggestions for continuous quality improvement in GxP and, specifically, GCP.
• Maintain expert up-to-date knowledge on GCP legislation and relevant parts of GxP guidelines and practices and ensure that the information is distributed and acknowledged by relevant parts of the Xentria Organization
• Facilitate review of potential Serious Breach and Urgent Safety Measure assessments arising from assigned clinical program
• Support Quality department for all GXP areas (e.g., GMP, GLP)
Training:
• Provide input for GCP and other relevant training in QA and the GCP area.
• Support the development and assessment of the corporate training management systems and assessments
Audits/Inspections:
• Develop and maintain the GCP audit strategy in collaboration with senior QA leadership.
• Prepare individual audit plans and audit/risk mitigation plans for larger projects/programs in support of the Xentria Audit Program.
• Plan, conduct, reported, and follow-up of internal audits, vendor (CRO) and site audits in accordance with current procedures
• Proactively assesses internal and external vendor compliance issues and risks, providing strong leadership and expertise in setting and maintaining compliance standards
• Clearly communicate and report (verbally and in writing) audit outcomes to the Xentria organization and escalate quality issues as required.
• Support Xentria Inspection Readiness activities
Clinical Quality:
• Responsibilities to collaborate/support clinical trial management, clinical development, and the implementation of Risk Based Quality Management within assigned program(s); identifying and evaluating the remediation of fundamental risks and quality issues internally, at Vendors and clinical sites; and collaborating with stakeholders to ensure inspection readiness for assigned programs, laying the foundation for successful outcomes during submission-related and unannounced inspections
• Develop and maintains effective working relationships with stakeholder functions to achieve GCP QA and compliance goals.
• Provide input to the preparation of documents for internal reports, external partner reports and/or regulatory filings
• Represent QA in study team(s) where relevant and participate as appropriate to ensure clinical trials are conducted in compliance with clinical protocols, GCP and other regulatory requirements.
• Responsible for QA review of key study documentation, SOPs, Vendor documentation, and relevant submission documentation.
• Lead a team of program oversight colleagues and ensure their continuous development
• Partner with key vendor QA functions to remediate risk and manage emerging issues
• Assists with developing, implementing and communicating the strategic vision for GCP compliance to maximize employee focus, while maintaining a strong independent role for QA and compliance-related decisions
• Report on Quality activities on a regular basis to the Executive and Senior Leadership Teams, ensuring accurate and timely reporting of the relevant Key Performance Indicators
• Evaluate all Quality systems and processes and recommend and implement appropriate enhancements to ensure the achievement of Xentria’s near-term and long-term objectives.
• Lead efforts and collaborate with all internal and external partners to ensure readiness of all GxP activities required for inspections associated with clinical product filings.
• Ensure appropriate Quality Leadership of all partner and regulatory authority audits and inspections of the clinical program.
• Facilitate Quality Oversight Committee meetings with Vendors.
• Provide Quality support for Governance Meetings with select Vendors.
Supervisory Responsibilities
No direct reports associated at this time but one or more direct reports in the future.
Competencies
• Demonstrated ability to lead people and develop positive relationships and collaborations.
• Demonstrated ability to manage multiple and diverse projects concurrently.
• Strong analytical skills; a strategic thinker, planner, and implementer.
• Reliable, dependable, and consistent worker.
• Strong ability to create practical and efficient processes.
• Highly effective interpersonal skills in individual as well as in group settings.
• Strong communication skills, both written and verbal.
• Enthusiastic, genuine, ethical, fair, and loyal to the organization and its vision and goals.
• Results-oriented; able to determine approaches to assignments
• Problem-solving skills with the ability to analyze situations and/or data while considering future impact and intangible variables
• Demonstrated attention to detail, accuracy, excellent review and analytical skills in a fast-paced environment
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Minimum of 20 years’ experience in the pharmaceutical or biotechnology industry with minimum 10 years in a quality leadership role
• Expert knowledge of GxP, FDA, EMA and other regional regulations.
• Experience in multiple disciplines within Quality Assurance and Quality Risk Management, e.g., auditing, GCP oversight, electronic systems management, vendor management, CAPA management, inspection readiness and leadership.
• Established expertise and training in GxP systems
• Functional planning experience and ability to develop functional vision, priorities, and tactics
• Clinical Site, CRO or Sponsor Clinical Study/Clinical Operations experience
• Experience with product development lifecycle
• Experience conducting remote and digital audits
Education and / or Experience Required
Bachelor’s degree in health sciences or related field
Travel
Up to 20% domestic and/or international travel expected with occasional travel to Chicago office.
Computer Skills
Microsoft Word, Excel, PowerPoint and Project, Quality Management Systems (e.g. ACE, Qualio), electronic Trial Master Files
Physical Demands
While performing the duties of this Job, the employee is frequently required to stand; walk; sit and talk or hear. The employee must occasionally lift and/or move up to 20 pounds.
Work Environment
This is a remote position.
AAP/ EEO Statement
Equal Opportunity Employer Minorities/Women/Veterans/Disabled.
12/3/2024
Sr. Director, Strategic Marketing and Communication
Summary
Xentria is committed to advancing drug development through meaningful patient engagement and effective partnerships and has a track record of success in securing key collaborations in the life sciences industry. The team at Xentria is dedicated to helping early-stage products advance to the next stage of clinical development, getting them one step closer to commercial launch. Established in 2020 and headquartered in Chicago, Xentria collaborates closely with academic researchers, patient communities and biotechs as we commit to embracing the complexities of co-development projects.
Xentria is seeking a highly motivated Sr. Director, Strategic Marketing and Communication to lead the development and execution of our organization's strategic engagement. This role reports to the VP of Marketing and Patient Affairs and will work in collaboration with them to implement the overall marketing strategy, ensuring alignment with corporate goals and product roadmaps.
Essential Duties and Responsibilities
Essential Duties and Responsibilities include the following. Other duties may be assigned.
• Lead the tactical execution of integrated marketing campaigns across multiple channels, including digital, print, and events.
• Identify new growth opportunities and pre/post-commercial market trends to refine and optimize marketing plans.
• Track industry trends and emerging technologies to help shape future marketing initiatives.
• Collaborate with the Vice President of Marketing for development and execution of the company’s digital marketing strategy, including SEO, email marketing, and social media.
• Oversee content marketing initiatives, working closely with the internal content team and external agencies to create scientific articles, white papers, case studies, and other materials that enhance brand positioning and thought leadership.
• Collaborate with leadership on the development and execution of product marketing strategies for a company’s portfolio, including product positioning, messaging, and launch plans.
• Collaborate with affiliate R&D, sales, and regulatory teams to ensure the successful commercialization of new products or technologies.
• Lead the creation of compelling marketing materials, ensuring that scientific and technical content is communicated effectively to key audiences, including healthcare professionals, researchers, and/or investors.
• Work closely with cross functional team to ensure that marketing efforts are aligned with company objectives and that marketing collateral supports the needs of the field.
• Collaborate with the regulatory and medical affairs teams to ensure compliance with industry regulations and guidelines.
• Support the business development team in identifying new partnership opportunities and creating marketing presentations for potential stakeholders.
Supervisory Responsibilities
One or more direct reports associated.
Competencies
• Teamwork
• Professionalism
• Cross-functional collaboration
• Judgement
• Ethics
• Interpersonal communication
• Project Management
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Ability to work in a dynamic, start-up organization with aggressive timelines and multiple deliverables.
• Strong communication skills and ability to communicate ideas clearly both orally and in writing.
• Highly motivated and ability to collaborate with a team and work autonomously.
• Highly organized and high attention to detail.
• Strong analytical and problem solving skills
• Proven ability to manage multiple tasks at a time and ability to meet deadlines.
Education and / or Experience Required
Required:
• Bachelor’s degree in health sciences or related field; Masters preferred.
• Minimum 10 years’ experience in biotech or pharma environment; strong oncology therapeutic experience required.
• Marketing and drug development experience
Travel
Up to 10% domestic and/or international travel expected with routine travel to Chicago office.
Computer Skills
Microsoft Word, Excel, PowerPoint, and Project(preferred)
Physical Demands
While performing the duties of this job, the employee is frequently required to stand; walk; sit and talk or hear. The employee must occasionally lift and/or move up to 20 pounds.
Work Environment
This is a remote position.
AAP/ EEO Statement
Equal Opportunity Employer Minorities/Women/Veterans/Disabled.