Careers

X4 offers a place where patient-focus is our priority and encourage people who share this value to apply. We offer a team-based approach in a collegial environment. We place a high importance on individual career development to enable one to meet his or her professional goals.

X4 is seeking key team members who:

  • Problem solve and who execute with high precision
  • Say what they mean, and let their words match their actions
  • Enjoy a team environment and foster direct and open communications

X4 is an equal opportunity employer and offers a comprehensive and competitive benefits package. Full-time employees are eligible for all benefits on their date of hire.

  • Health plan
  • Dental plan
  • Life/ADD insurance
  • Short- and long-term disability insurance
  • 401(k) plan for retirement savings
  • Subsidized parking or MBTA pass
  • Competitive Paid Time Off / Holidays

Open Positions

Location: Cambridge MA, USA

Senior Director, Regulatory Affairs

Company Description:

X4 is focused on restoring healthy immune system function by developing novel therapeutics for the treatment of rare diseases.

Our first-in-class, oral, small molecule therapeutics are antagonists of chemokine receptor CXCR4, which have the potential to treat a broad range of rare diseases, including primary immunodeficiencies (PIs) and cancer. A number of PIs are attributed to the improper trafficking of immune cells related to the CXCR4 receptor and its ligand CXCL12.

X4 Pharmaceutical’s lead product candidate, mavorixafor (X4P-001), is a potentially first-in-class, once-daily, oral inhibitor of CXCR4, currently in Phase 3 development for the treatment of WHIM syndrome, a rare, inherited, primary immunodeficiency disease caused by genetic mutations in the CXCR4 receptor gene. Mavorixafor has demonstrated proof of concept in WHIM in a Phase 2 trial, including clinically meaningful increases in neutrophil and lymphocyte biomarker counts, as well as a trend of reduction in infection rates and wart burden, and a favorable safety profile. A Phase 2 open label extension study for WHIM is ongoing. Mavorixafor was designated orphan drug status by the U.S. Food and Drug Administration in 2018 for the treatment of WHIM and is also in development for Severe Congenital Neutropenia (SCN), Waldenström’s macroglobulinemia (WM), and clear cell renal cell carcinoma (ccRCC).

X4 is also developing X4P-002, a CXCR4 antagonist that has unique properties that the company believes will enable penetration of the blood-brain barrier and provide appropriate therapeutic exposures to treat brain cancers, including glioblastoma multiforme (GBM).

Reporting to the Vice President, Regulatory Affairs and Program Management, the Senior Director, Regulatory Affairs will be responsible for leading and implementing the global regulatory strategic plans for the development of current and future indications in conjunction with the regulatory therapeutic leads. The individual must possess excellent leadership judgment, organizational and planning experience along with exceptional written, verbal and electronic communication skills. The successful candidate will also have the ability to influence and negotiate professionally at all levels of the organization within project teams, and with strategic external partners, while maintaining positive working relationships.

To succeed at X4, the candidate will have a sustained reputation for putting the patient first and foremost, as well as a values-driven work style where integrity and grit drive all behaviors, decisions and actions.

 

Scope of Work and Accountabilities:

The Senior Director, Regulatory Affairs is responsible for developing, implementing, and advising on global regulatory strategies for development programs to secure and maintain market access for product(s) in line with business objectives, and in coordination with key internal stakeholders.

He/She will manage regulatory aspects of compounds through all phases of development, postapproval, and life-cycle of the product. The incumbent will provide leadership and strategic regulatory oversight on projects including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approval in domestic and international markets, regulatory strategic development plans and risk assessments, critical issue management and advice on Health Authority.

The individual will have departmental and corporate level influence and accountabilities and serves as an advisor/liaison to senior management to plan, evaluate and recommend regulatory strategy. Externally, the individual will interface with outside regulatory agencies and business partners regarding development, regulatory, and registration strategies. He/she may have line management, people development and performance management responsibilities, as well as support/lead development and implementation of department policies. The candidate will also act as the regulatory head as the surrogate for the Vice President, Regulatory Affairs and Program Management.

  • Provides high level strategic and operational regulatory direction and risk assessment for designated projects ensuring that the latest requirements and standards are met
  • Drives and is accountable for the preparation and submission of documentation to support investigational and marketing registration packages throughout the US & Global markets
  • Reviews and provides expertise for the sections of IND/CTA, NDA/MAA, and other global submission documents in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements
  • Liaises and negotiates with global regulatory authorities as needed for all aspects of drug development, including resolution of key regulatory issues and expediting approvals of product and labeling activities
  • Maintains awareness of the current global regulatory environment and assesses the impact of changes on business and product development programs and corporate risk
  • Facilitates the policy and development of the standard interpretation of global regulations
  • Integrates functional expertise with business knowledge to assess risk, solve problems and recommend solutions
  • Develop and implement creative approaches to ensure complaint regulatory success with the ability to innovate, analyze, and solve problems
  • Teach, develop and manage a high performing team, via direct and indirect reporting structures
  • Develops strong partnerships with cross functional senior key stakeholders to ensure that strategic business goals are met through the sharing of knowledge and teamwork
  • Brings expertise to the development and implementation of regulatory processes
  • Recruits, develops, leads and mentors top performing regulatory professionals, and helps create a goal-oriented culture

 

Qualifications and Professional Experience:

  • Bachelor’s degree required, advanced degree preferred
  • A minimum of 10 years in the biotechnology and/or biopharmaceutical industry
  • Minimum seven years in a Regulatory capacity with experience in several therapeutic areas, preferably in biotech and biopharma through commercialization
  • Preferred candidates will have experience working as a lead in Regulatory Affairs across two or more major geographic areas and prior experience with both small molecules and biologics
  • Proven experience as a respected leader of high performing talent
  • Expert in global regulatory guidelines required to lead the overall regulatory strategy
  • Demonstrated experience interacting with the Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regulatory agencies
  • Proven leadership experience in the establishment and submission of INDs and approvals of NDAs and BLAs
  • Expertise in the drug development process with experience in multiple phases (early and late stage, post-approval) in various therapeutic areas
  • Understanding and implementing the life-cycle of a product from Phase III to commercialization within a Regulatory capacity

 

The above statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all responsibilities.

X4 Pharmaceuticals is an Equal Opportunity and Affirmative Action Employer committed to a culturally diverse workforce. All qualified candidates will receive consideration without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital, domestic partnership or civil union status, sex, gender identity or expression, sexual orientation, disability, veteran status, violence victim status or any other characteristic protected by law. Please send your resume and cover letter to careers@x4pharma.com.

In-house Clinical Research Associate

Company Description:

X4 is focused on restoring healthy immune system function by developing novel therapeutics for the treatment of rare diseases.

Our first-in-class, oral, small molecule therapeutics are antagonists of chemokine receptor CXCR4, which have the potential to treat a broad range of rare diseases, including primary immunodeficiencies (PIs) and cancer. A number of PIs are attributed to the improper trafficking of immune cells related to the CXCR4 receptor and its ligand CXCL12.

X4 Pharmaceutical’s lead product candidate, mavorixafor (X4P-001), is a potentially first-in-class, once-daily, oral inhibitor of CXCR4, currently in Phase 3 development for the treatment of WHIM syndrome, a rare, inherited, primary immunodeficiency disease caused by genetic mutations in the CXCR4 receptor gene. Mavorixafor has demonstrated proof of concept in WHIM in a Phase 2 trial, including clinically meaningful increases in neutrophil and lymphocyte biomarker counts, as well as a trend of reduction in infection rates and wart burden, and a favorable safety profile. A Phase 2 open label extension study for WHIM is ongoing. Mavorixafor was designated orphan drug status by the U.S. Food and Drug Administration in 2018 for the treatment of WHIM and is also in development for Severe Congenital Neutropenia (SCN), Waldenström’s macroglobulinemia (WM), and clear cell renal cell carcinoma (ccRCC).

X4 is also developing X4P-002, a CXCR4 antagonist that has unique properties that the company believes will enable penetration of the blood-brain barrier and provide appropriate therapeutic exposures to treat brain cancers, including glioblastoma multiforme (GBM).

Reporting to the Associate Director, Clinical Operations the In-House Senior Clinical Research Associate will be responsible for the day to day operational support of all processes of planning, start-up, initiation and close out of all clinical trial sites. This role will require he/she to be onsite in the Cambridge, MA office when not traveling.

To succeed at X4, the candidate will have a sustained reputation for putting the patient first and foremost, as well as a values-driven work style where integrity and grit drive all behaviors, decisions and actions.

 

Scope of Work and Accountabilities:

  • Responsible for supporting all processes of planning, start-up, initiation and conduct of assigned clinical trials.
  • Accountable for day-to-day operational support to Clinical Study Lead and field CRAs in all study-related activities.
  • Participate in the vendor selection process and oversee and track ongoing CRO and vendor activities as appropriate.
  • Assist in the development of study-related documents (ICFs, protocols, IBs, study plans, study manuals, etc.).
  • Track the progress of assigned clinical trials, such as study subject tracking, essential document tracking, and sample tracking.
  • Monitor clinical trials on site and remotely in accordance with Good Clinical Practices (GCP).
  • Expedite the start-up and progress of clinical investigations by conducting pre-study, initiation, interim and close out visits to sites.
  • Ensure all monitoring activities are conducted to ensure quality at each site and adherence to GCP.
  • Obtain and review regulatory documentation for successful implementation, monitoring, and evaluation of sites
  • Review the quality and integrity of the clinical data through remote and on-site review of electronic CRF data and on-site source document verification.
  • Assist in the development of study-related documents (ICFs, protocols, IBs, study plans, study manuals, etc.).
  • Approve and verify invoices, request payments for sites from CROs and vendors

 

Qualifications and Professional Experience:

  • Minimum of bachelor’s or associate degree in health sciences or related field.
  • 2-3 years’ experience in clinical research with at least 1-2 years’ experience in the Pharmaceutical/Biotechnology industry as a Clinical Research Associate or similar position and expertise in Clinical Trial Monitoring.
  • Documented training, knowledge and application of current FDA Regulations and ICH GCP guidelines in clinical trials required.
  • Experience developing trial plans including site monitoring, trial budgets, site selection and clinical supply management.
  • Ability to work successfully within a cross-functional team.
  • Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines.

Preferred:

  • Experience working for both Sponsor and CRO.
  • Experience in rare orphan disease and oncology clinical trials and medical knowledge and education.

 

The above statements are intended to describe the general nature and level of work being performed.  They are not intended to be construed as an exhaustive list of all responsibilities.

X4 Pharmaceuticals is an Equal Opportunity and Affirmative Action Employer committed to a culturally diverse workforce.  All qualified candidates will receive consideration without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital, domestic partnership or civil union status, sex, gender identity or expression, sexual orientation, disability, veteran status, violence victim status or any other characteristic protected by law.   Please send your resume and cover letter to careers@x4pharma.com.  

Director, CMC Program Management

Company Description:

X4 is focused on restoring healthy immune system function by developing novel therapeutics for the treatment of rare diseases.

Our first-in-class, oral, small molecule therapeutics are antagonists of chemokine receptor CXCR4, which have the potential to treat a broad range of rare diseases, including primary immunodeficiencies (PIs) and cancer. A number of PIs are attributed to the improper trafficking of immune cells related to the CXCR4 receptor and its ligand CXCL12.

X4 Pharmaceutical’s lead product candidate, mavorixafor (X4P-001), is a potentially first-in-class, once-daily, oral inhibitor of CXCR4, currently in Phase 3 development for the treatment of WHIM syndrome, a rare, inherited, primary immunodeficiency disease caused by genetic mutations in the CXCR4 receptor gene. Mavorixafor has demonstrated proof of concept in WHIM in a Phase 2 trial, including clinically meaningful increases in neutrophil and lymphocyte biomarker counts, as well as a trend of reduction in infection rates and wart burden, and a favorable safety profile. A Phase 2 open label extension study for WHIM is ongoing. Mavorixafor was designated orphan drug status by the U.S. Food and Drug Administration in 2018 for the treatment of WHIM and is also in development for Severe Congenital Neutropenia (SCN), Waldenström’s macroglobulinemia (WM), and clear cell renal cell carcinoma (ccRCC).

X4 is also developing X4P-002, a CXCR4 antagonist that has unique properties that the company believes will enable penetration of the blood-brain barrier and provide appropriate therapeutic exposures to treat brain cancers, including glioblastoma multiforme (GBM).

Reporting to the SVP, Technical Operations & Quality, the Director, CMC Program Management will be responsible for the application of program/project management skills with a solid foundation of technical capability established from experience in a relevant small molecule development discipline.

A deep understanding regarding the interdependency of CMC functions (Process Chemistry, Pharmaceutical Development, Analytical Development, Quality, CMC Regulatory and Supply Chain). Also, the incumbent will need to have expertise on how the combined CMC Team delivers for nonclinical, clinical and commercial program activities. Leveraging their technical understanding, he/she will develop and foster strong collaborative working relationships with team members across different functions and at different levels within the organization.

To succeed at X4, the candidate will have a sustained reputation for putting the patient first and foremost, as well as a values-driven work style where integrity and grit drive all behaviors, decisions and actions.

 

Scope of Work and Accountabilities:

  • Develop and drive an integrated CMC strategy to deliver on corporate program goals by working with functional subject matter experts within Process Chemistry, Pharmaceutical Development, Analytical Development, Quality, Supply Chain and CMC Regulatory
  • Lead the CMC Team to establish and maintain integrated CMC development plans from candidate identification through commercialization including risk and appropriate contingencies
  • Align CMC plans with overall mavorixafor assets, Clinical Development and Commercial program plans
  • Drive and hold CMC Team accountable for CMC milestones, deliverables and dependencies so the organization will consistently meet program needs
  • Facilitate pertinent CMC scenario planning around key program inflexion points, gather stakeholder input, evaluate, collate, manage and communicate implications and adjustments to the overall plan and budget of the CMC function
  • Integrate, represent and drive cross functional communication between CMC Team members, Program Teams and other impacted areas with timely and effective decision making
  • Develop, manage and drive integrated CMC timelines with smaller functional groups or sub-teams
  • Develop, lead and implement a critical path analyses to identify potential ways to accelerate timelines and mitigate risks
  • Represent the CMC team as the subject matter expert during the clinical development and commercialization program meetings, communicate progress, risks, changes, and implications
  • Participate in the development and review of critical technical and regulatory documents with a responsibility to assure overall consistency and accuracy of CMC messaging with appropriate supporting technical information
  • In collaboration with CMC Team members and Finance, develop and manage the integrated CMC budget and long-range plan to align and execute on corporate goals

 

Qualifications and Professional Experience:

  • MS or PhD in a technical discipline; Chemistry or Pharmaceutical Sciences
  • 10+ years in small molecule biotech/pharma technical development function (e.g. process chemistry, drug product development, analytical development), late stage development experience preferred
  • Preferred candidates will have strong interpersonal skills with an ability to motivate others, influence without authority and negotiate conflict situations
  • Demonstrated experience in a highly collaborative team that fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
  • Proven experience to refine complex plans across multiple programs into an intuitive, simple and clear communication
  • Leadership experience with managing programs/projects, budgets and resources to enhance business objectives within a matrix-oriented environment

 

The above statements are intended to describe the general nature and level of work being performed.  They are not intended to be construed as an exhaustive list of all responsibilities.

X4 Pharmaceuticals is an Equal Opportunity and Affirmative Action Employer committed to a culturally diverse workforce.  All qualified candidates will receive consideration without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital, domestic partnership or civil union status, sex, gender identity or expression, sexual orientation, disability, veteran status, violence victim status or any other characteristic protected by law.   Please send your resume and cover letter to careers@x4pharma.com.  

Director, R&D Quality

Company Description:

X4 is focused on restoring healthy immune system function by developing novel therapeutics for the treatment of rare diseases.

Our first-in-class, oral, small molecule therapeutics are antagonists of chemokine receptor CXCR4, which have the potential to treat a broad range of rare diseases, including primary immunodeficiencies (PIs) and cancer. A number of PIs are attributed to the improper trafficking of immune cells related to the CXCR4 receptor and its ligand CXCL12.

X4 Pharmaceutical’s lead product candidate, mavorixafor (X4P-001), is a potentially first-in-class, once-daily, oral inhibitor of CXCR4, currently in Phase 3 development for the treatment of WHIM syndrome, a rare, inherited, primary immunodeficiency disease caused by genetic mutations in the CXCR4 receptor gene. Mavorixafor has demonstrated proof of concept in WHIM in a Phase 2 trial, including clinically meaningful increases in neutrophil and lymphocyte biomarker counts, as well as a trend of reduction in infection rates and wart burden, and a favorable safety profile. A Phase 2 open label extension study for WHIM is ongoing. Mavorixafor was designated orphan drug status by the U.S. Food and Drug Administration in 2018 for the treatment of WHIM and is also in development for Severe Congenital Neutropenia (SCN), Waldenström’s macroglobulinemia (WM), and clear cell renal cell carcinoma (ccRCC).

X4 is also developing X4P-002, a CXCR4 antagonist that has unique properties that the company believes will enable penetration of the blood-brain barrier and provide appropriate therapeutic exposures to treat brain cancers, including glioblastoma multiforme (GBM).

Reporting to the Senior Director of Quality, the Director R&D Quality will lead and drive the oversight of GCP, GLP and GVP related activities at X4 Pharma. Serve as lead representative for multiple Clinical Study Teams, and lead Clinical Inspection Readiness efforts across the organization. Partner with operations teams to implement and maintain GCP, GLP, and GVP quality systems; this will include managing and conducting audits of external service providers including CROs, Vendors (e.g. Pre-clinical laboratories, Clinical testing labs, Data Management Services etc.), Research, and Clinical Investigator sites.

The incumbent will ensure high quality execution of clinical trials from first in human through commercial marketing authorization. Develop and foster cross-functional relationships with internal and external stakeholders.

To succeed at X4, the candidate will have a sustained reputation for putting the patient first and foremost, as well as a values-driven work style where integrity and grit drive all behaviors, decisions and actions.

 

Scope of Work and Accountabilities:

  • Lead and drive the R&D Quality function within the Quality department to meet organizational goals and objectives
  • Improve existing GCP, GLP and GVP Quality Systems in partnership with Operations teams
  • Formulate and implement Standard Operating Procedures that align and address business priorities and compliance with applicable regulations
  • Develop and build operational tools for implementation of Quality Systems in collaboration with the Operations team
  • Partner and deliver oversight and guidance on GCP compliance matters within Clinical Study teams
  • Develop, implement and execute a risk-based audit strategy for active clinical programs in the current pipeline
  • Lead and manage GLP, GCP and GVP audits including oversight of consultant mediated and/or self-conducted Vendor Qualification, System, Study, and Process Audits
  • Provide day-to-day quality and compliance support, including issue management (triage/investigation/actions), proactive quality management, protocol deviation review, audit/protocol deviation/issue trending
  • Assist and advise in the development of CAPA plans in response to audits/inspections and review and follow-up of all audit CAPAs
  • Establish Quality Agreements with Vendors, as applicable
  • Provide training sessions and mentor top performing teams on topics related to GCP, GLP and GVP quality and global regulations
  • Apply experience, quality knowledge and expertise when auditing eTMFs to ensure alignment with clinical trials and internal requirements
  • Review key non-clinical, safety and clinical documents including protocols/amendments, study plans and regulatory documents (e.g. DSUR, IB, IND and NDA)
  • Conduct CRO, Investigator site monitoring, and Inspection Readiness along with assess and communicate findings to key stake holders
  • Identify QA and compliance related issues and implement solutions to ensure timelines are maintained
  • Promote and deliver performance improvement evaluations with the Clinical Study Team and key stakeholders through a proactive Inspection Readiness Program
  • Periodically report the state of Clinical Quality and compliance of clinical trials to X4 Senior Management

 

Qualifications and Professional Experience:

  • MS or PhD in engineering or life sciences discipline with a minimum of 12 years of relevant industry experience in sponsor companies, CROs, or consulting firms
  • Experience with rare disease and/or oncology trial management
  • Deep knowledge of First in Human trial management
  • Extensive knowledge and understanding of ICH E6 (R2) GCP Guideline, FDA and EU Requirements
  • Experience and understanding of Data Integrity requirements and Electronic Data Capture systems in Clinical trials
  • Direct experience in managing Health Authority GCP Inspections. Experience supporting BIMO inspections is highly preferred.
  • Proven experience with developing strong partnerships with cross functional senior key stakeholders to ensure that strategic business goals are met through the sharing of knowledge and teamwork
  • Demonstrated experience with content ownership, delivery and strategic thinking
  • Extensive knowledge and understanding of all related study monitoring activities
  • Comprehensive understanding with the infrastructure and operational characteristics of CROs and centralized services
  • Demonstrated effective time management skills, ability to work independently and in a team environment that drives business needs forward
  • Ability to travel domestically and internationally up to 15-20%

 

The above statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all responsibilities.

X4 Pharmaceuticals is an Equal Opportunity and Affirmative Action Employer committed to a culturally diverse workforce. All qualified candidates will receive consideration without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital, domestic partnership or civil union status, sex, gender identity or expression, sexual orientation, disability, veteran status, violence victim status or any other characteristic protected by law. Please send your resume and cover letter to careers@x4pharma.com.

Director, Manufacturing and Supply Chain Quality

Company Description:

X4 is focused on restoring healthy immune system function by developing novel therapeutics for the treatment of rare diseases.

Our first-in-class, oral, small molecule therapeutics are antagonists of chemokine receptor CXCR4, which have the potential to treat a broad range of rare diseases, including primary immunodeficiencies (PIs) and cancer. A number of PIs are attributed to the improper trafficking of immune cells related to the CXCR4 receptor and its ligand CXCL12.

X4 Pharmaceutical’s lead product candidate, mavorixafor (X4P-001), is a potentially first-in-class, once-daily, oral inhibitor of CXCR4, currently in Phase 3 development for the treatment of WHIM syndrome, a rare, inherited, primary immunodeficiency disease caused by genetic mutations in the CXCR4 receptor gene. Mavorixafor has demonstrated proof of concept in WHIM in a Phase 2 trial, including clinically meaningful increases in neutrophil and lymphocyte biomarker counts, as well as a trend of reduction in infection rates and wart burden, and a favorable safety profile. A Phase 2 open label extension study for WHIM is ongoing. Mavorixafor was designated orphan drug status by the U.S. Food and Drug Administration in 2018 for the treatment of WHIM and is also in development for Severe Congenital Neutropenia (SCN), Waldenström’s macroglobulinemia (WM), and clear cell renal cell carcinoma (ccRCC).

X4 is also developing X4P-002, a CXCR4 antagonist that has unique properties that the company believes will enable penetration of the blood-brain barrier and provide appropriate therapeutic exposures to treat brain cancers, including glioblastoma multiforme (GBM).

Reporting to the Senior Director of Quality, the Director Manufacturing and Supply Chain Quality will lead and drive the GMP Quality Operations related activities at X4 Pharma. This role will represent Quality on CMC teams for all X4 programs, will partner internally with Quality Systems, Analytical Development, Process and Product Development, CMC Leadership and Supply Chain functions to develop and implement phase appropriate quality systems to support commercialization of X4 products and to ensure the availability of product for X4’s clinical trials, and foster strong relationships with external partners to build a quality focused, efficient and collaborative culture to meet department and company goals.

The incumbent will ensure high quality execution of manufacturing and supply chain operations for clinical products and establish readiness for commercial marketing authorization and launch. The role requires to champion and drive multiple workstreams.

To succeed at X4, the candidate will have a sustained reputation for putting the patient first and foremost, as well as a values-driven work style where integrity and grit drive all behaviors, decisions and actions.

 

Scope of Work and Accountabilities:

  • Lead and implement the Manufacturing and Supply Chain Quality function within the Quality department to meet organizational goals and objectives
  • Shape and drive Quality culture, fostering a proactive, phase appropriate quality focused approach
  • Participate in the effective quality oversight of cGMP activities at X4 and its external manufacturing and testing partners for clinical stage products
  • Improve existing and develop/implement new GMP Quality Systems in partnership with Quality Systems and Technical Operations in  support of product commercialization in compliance with applicable regulation
  • Partner and provide oversight and guidance on GMP compliance matters within CMC teams
  • Develop, implement and execute a risk-based audit strategy for GMP Vendors
  • Lead and manage GMP audits including oversight of consultant mediated and/or self-conducted Vendor Qualification audits
  • Assist and advise in the development of CAPA plans in response to audits/inspections and review and follow-up of all audit CAPAs
  • Establish Quality Agreements with Vendors
  • Ensure products for human use are manufactured in compliance with the applicable requirements, regulations and guidance and meet appropriate quality specifications and standards
  • Provide day-to-day quality and compliance support, including issue management (triage/investigation/actions), batch record review, lot disposition, change controls etc.
  • Provide and drive training sessions and mentor top performing teams on topics related to GMP quality and global regulations
  • Partner with key internal and external partners to champion a prospective Inspection Readiness Program
  • Periodically report the state of GMP Quality and compliance to X4 Senior Management
  • Establish a strong interface with the external development and manufacturing partners while building strong relationships and fostering continuous improvement
  • Support all product development and commercialization related activities, including process performance qualification, submission of regulatory filings, and product launch

 

Qualifications and Professional Experience:

  • BS or MS in engineering or life sciences technical discipline
  • Minimum 12 years of relevant industry experience in Quality Assurance, including management of virtual manufacturing and distribution supply chain
  • Experience with rare disease products is a plus
  • Knowledge and understanding of ICH Guidelines, and FDA and EU Requirements
  • In-depth knowledge and understanding of Data Integrity requirements
  • Direct experience in managing Health Authority GMP Inspections is highly preferred.
  • Proven experience with developing strong partnerships with cross functional senior key stakeholders to ensure that strategic business goals are met through the sharing of knowledge and teamwork
  • Demonstrated experience with content ownership, delivery and strategic thinking
  • Proven effective time management skills, ability to work independently and in a team environment that drives business needs forward
  • Must be willing to travel domestically and internationally up to 25%

 

The above statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all responsibilities.

X4 Pharmaceuticals is an Equal Opportunity and Affirmative Action Employer committed to a culturally diverse workforce. All qualified candidates will receive consideration without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital, domestic partnership or civil union status, sex, gender identity or expression, sexual orientation, disability, veteran status, violence victim status or any other characteristic protected by law. Please send your resume and cover letter to careers@x4pharma.com.

Associate Director, Clinical Operations, Rare Disease

Company Description:

X4 is focused on restoring healthy immune system function by developing novel therapeutics for the treatment of rare diseases.

Our first-in-class, oral, small molecule therapeutics are antagonists of chemokine receptor CXCR4, which have the potential to treat a broad range of rare diseases, including primary immunodeficiencies (PIs) and cancer. A number of PIs are attributed to the improper trafficking of immune cells related to the CXCR4 receptor and its ligand CXCL12.

X4 Pharmaceutical’s lead product candidate, mavorixafor (X4P-001), is a potentially first-in-class, once-daily, oral inhibitor of CXCR4, currently in Phase 3 development for the treatment of WHIM syndrome, a rare, inherited, primary immunodeficiency disease caused by genetic mutations in the CXCR4 receptor gene. Mavorixafor has demonstrated proof of concept in WHIM in a Phase 2 trial, including clinically meaningful increases in neutrophil and lymphocyte biomarker counts, as well as a trend of reduction in infection rates and wart burden, and a favorable safety profile. A Phase 2 open label extension study for WHIM is ongoing. Mavorixafor was designated orphan drug status by the U.S. Food and Drug Administration in 2018 for the treatment of WHIM and is also in development for Severe Congenital Neutropenia (SCN), Waldenström’s macroglobulinemia (WM), and clear cell renal cell carcinoma (ccRCC).

X4 is also developing X4P-002, a CXCR4 antagonist that has unique properties that the company believes will enable penetration of the blood-brain barrier and provide appropriate therapeutic exposures to treat brain cancers, including glioblastoma multiforme (GBM).

The Associate Director, Clinical Operations is an experienced clinical leader focused on the successful management of global programs in rare disease. The incumbent will work independently and collaboratively in a variety of clinical meetings, projects, and tasks. The Associate Director is an integral member of the Clinical Operations team and is a forward thinker looking to advance the mission and values of X4.

To succeed at X4, the candidate will have a sustained reputation for putting the patient first and foremost, as well as a values-driven work style where integrity and grit drive all behaviors, decisions and actions.

 

Scope of Work and Accountabilities:

  • Responsible for the successful management of the rare disease clinical programs by day-to-day CRO management
  • Act as the liaison between CRO’s and establish quality guidelines to ensure CRO’s are meeting standards in accordance to X4’s Standard Operating Procedures
  • Provide strategic input on clinical operations pipeline and goals that align with the business needs
  • Ensure timely responses to clinical site staff and all regulatory agencies
  • Develop close relationships with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships; lead planning and conduct of investigator’s meetings
  • Collaborate with cross-functional counterparts to oversee the performance for all activities assigned to our strategic partners, CROs and other vendors, including escalation of issues to governance committees and to senior management when warranted
  • Serve as a leader to proactively audit and inspect clinical operations activities for efficiency, quality, and progress
  • Provide expertise on related clinical operation documents and publications as needed
  • Develop and improve already existing clinical operations guidelines within the organization
  • Monitor study progress, data collection, and clean-up for all clinical trials
  • Participate in clinical operations department initiatives including preparation, review, and training of SOPs
  • Prepare and present clinical development trial updates to project teams and management and review any potential issues or recommendations

 

Qualifications and Professional Experience:

  • Bachelor’s Degree in Life Sciences or Healthcare discipline
  • 7-12 years of relevant Clinical Operations experience in Biotech/Biopharmaceutical industry
  • Experience with NDA and BLA submissions as well as FDA regulations and other international regulatory agencies
  • Deep knowledge with clinical operation concepts and operational practices
  • Proven experience of successful management and interaction with CROs, vendors, and other external clients
  • Proven track record of managing multiple projects and/or programs concurrently
  • Ability to effectively represent functional expertise at a cross-functional team level
  • Understand the concepts and implementation of budget development

 

The above statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all responsibilities.

X4 Pharmaceuticals is an Equal Opportunity and Affirmative Action Employer committed to a culturally diverse workforce. All qualified candidates will receive consideration without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital, domestic partnership or civil union status, sex, gender identity or expression, sexual orientation, disability, veteran status, violence victim status or any other characteristic protected by law. Please send your resume and cover letter to careers@x4pharma.com.

Senior Executive Assistant

Company Description:

X4 is focused on restoring healthy immune system function by developing novel therapeutics for the treatment of rare diseases.

Our first-in-class, oral, small molecule therapeutics are antagonists of chemokine receptor CXCR4, which have the potential to treat a broad range of rare diseases, including primary immunodeficiencies (PIs) and cancer. A number of PIs are attributed to the improper trafficking of immune cells related to the CXCR4 receptor and its ligand CXCL12.

X4 Pharmaceutical’s lead product candidate, mavorixafor (X4P-001), is a potentially first-in-class, once-daily, oral inhibitor of CXCR4, currently in Phase 3 development for the treatment of WHIM syndrome, a rare, inherited, primary immunodeficiency disease caused by genetic mutations in the CXCR4 receptor gene. Mavorixafor has demonstrated proof of concept in WHIM in a Phase 2 trial, including clinically meaningful increases in neutrophil and lymphocyte biomarker counts, as well as a trend of reduction in infection rates and wart burden, and a favorable safety profile. A Phase 2 open label extension study for WHIM is ongoing. Mavorixafor was designated orphan drug status by the U.S. Food and Drug Administration in 2018 for the treatment of WHIM and is also in development for Severe Congenital Neutropenia (SCN), Waldenström’s macroglobulinemia (WM), and clear cell renal cell carcinoma (ccRCC).

X4 is also developing X4P-002, a CXCR4 antagonist that has unique properties that the company believes will enable penetration of the blood-brain barrier and provide appropriate therapeutic exposures to treat brain cancers, including glioblastoma multiforme (GBM).

Reporting to the Chief Medical Officer, the Senior Executive Assistant will be responsible for a full scope of administrative assistance to the Chief Medical Officer. This individual will work on projects involving concentration, initiative, tact, and must exercise utmost discretion and confidentiality in all assignments. The Senior Executive Assistant must be a leader with proven experience in building collaborative relationships among his/her superiors, peers and subordinates. The successful candidate is a self- starter and able to understand the business priorities and work with little supervision. He/She will serve as the trusted gate keeper and will use their outstanding written, verbal and electronic communication skills as a critical voice of the company on behalf of the Chief Medical Officer. He/She will use sound judgment and juggle key tasks in a fast-moving environment that will contribute greatly to the mission of the organization. The successful candidate will have a proven record of high achievement, professionalism, reliability, and excellent organizational skills.

To succeed at X4, the candidate will have a sustained reputation for putting the patient first and foremost, as well as a values-driven work style where integrity and grit drive all behaviors, decisions and actions.

 

Scope of Work and Accountabilities:

  • Provide executive level support to the Chief Medical Officer.
  • Manage and maintain calendar management, requiring interaction with both internal and external executives and assistants, as well as consultants, to coordinate a variety of complex meetings and travel.
  • Demonstrate proficiency in preparing meeting materials such as Power Point presentations, meeting binders, agendas, minutes, making reservations, planning dietary needs, scheduling travel arrangements, communicating essential information to participants, etc.
  • Arrange and coordinate domestic and international travel, including meeting material preparation and expense reporting.
    Act as confidential assistant, preserving the confidentiality of information related to the organization and staff. Assist with confidential and/or sensitive matters; provide explanation and support where needed.
  • Compile and analyze data and prepare talking points for presentations, reports, and narratives.
  • Manage and contribute to the strategic prioritization of tasks, initiatives, and projects identified by the Chief Medical Officer.
  • Demonstrate poise and flexibility in a fast paced and dynamic environment. Able to prioritize and manage multiple projects simultaneously, and follow through on issues in a timely manner. Goes beyond responsibilities to help team accomplish tasks and goal.
  • Act as the point of contact and liaison with internal colleagues and proactively anticipates administrative needs of the Chief Medical Officer. Consistently recognizes ways to offer additional support, completing tasks to satisfaction.
  • Positively represent the team and Company to internal and external contacts, including company executives, Board members, potential business partners and vendors.

 

Qualifications and Professional Experience:

  • 8+ years’ experience as an Executive Assistant supporting a C-level in a high growth, publicly traded biotech company
  • In-depth knowledge of and experience in the biotech/biopharmaceutical industry
  • Ability to navigate and be successful in a fast-paced, highly-matrixed, dynamic work environment
  • Documented history of successful engagement with all levels of the organization and external partners
  • Ability to handle a wide variety of activities with significant attention to detail and use judgement with confidential matters with discretion
  • Demonstrated aptitude to anticipate needs and issues before they arise, proactively identify solutions and work independently
  • Experience with Microsoft Office programs, specifically Outlook, Excel, Word, and PowerPoint
  • Ability to think independently and fully integrate into a high achieving team environment

 

The above statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all responsibilities.

X4 Pharmaceuticals is an Equal Opportunity and Affirmative Action Employer committed to a culturally diverse workforce. All qualified candidates will receive consideration without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital, domestic partnership or civil union status, sex, gender identity or expression, sexual orientation, disability, veteran status, violence victim status or any other characteristic protected by law. Please send your resume and cover letter to careers@x4pharma.com.

Director, Supply Chain and Logistics

Company Description:

X4 is focused on restoring healthy immune system function by developing novel therapeutics for the treatment of rare diseases.

Our first-in-class, oral, small molecule therapeutics are antagonists of chemokine receptor CXCR4, which have the potential to treat a broad range of rare diseases, including primary immunodeficiencies (PIs) and cancer. A number of PIs are attributed to the improper trafficking of immune cells related to the CXCR4 receptor and its ligand CXCL12.

X4 Pharmaceutical’s lead product candidate, mavorixafor (X4P-001), is a potentially first-in-class, once-daily, oral inhibitor of CXCR4, currently in Phase 3 development for the treatment of WHIM syndrome, a rare, inherited, primary immunodeficiency disease caused by genetic mutations in the CXCR4 receptor gene. Mavorixafor has demonstrated proof of concept in WHIM in a Phase 2 trial, including clinically meaningful increases in neutrophil and lymphocyte biomarker counts, as well as a trend of reduction in infection rates and wart burden, and a favorable safety profile. A Phase 2 open label extension study for WHIM is ongoing. Mavorixafor was designated orphan drug status by the U.S. Food and Drug Administration in 2018 for the treatment of WHIM and is also in development for Severe Congenital Neutropenia (SCN), Waldenström’s macroglobulinemia (WM), and clear cell renal cell carcinoma (ccRCC).

X4 is also developing X4P-002, a CXCR4 antagonist that has unique properties that the company believes will enable penetration of the blood-brain barrier and provide appropriate therapeutic exposures to treat brain cancers, including glioblastoma multiforme (GBM).

Reporting to the Senior Vice President, Technical Operations & Quality, the Director, Supply Chain and Logistics will initially be responsible for managing the clinical supply chain for our current global blinded Phase III study and several new and ongoing open-label clinical studies. This role will expand over the next year to include the strategic and operational aspects of building and managing a commercial supply chain.

To succeed at X4, the candidate will have a sustained reputation for putting the patient first and foremost, as well as a values-driven work style where integrity and grit drive all behaviors, decisions and actions.

 

Scope of Work and Accountabilities:

Clinical:

  • Responsible for clinical supply continuity and risk management processes. Owning/and or assessing supply chain plans and inventories used to support both blinded and open label clinical supplies
  • Drive and Lead cross functional partnerships with Quality, Regulatory, Technical and Clinical partners
  • Collaborates with Clinical Operations to forecast initial and ongoing clinical drug supply needs and demand assumptions (enrollment rates, number of sites, number of countries etc.,) and assure successful start-up of and distribution to clinical sites
  • Represents Supply Chain on the CMC Team. Collaborates with Technical Operations to ensure drug substance and drug product availability, appropriate storage, shipment and handling instructions. Manage temperature excursions and handling deviations
  • Partners with Quality Assurance to enable global acceptance of clinical trial material and ensure compliance across all stages of clinical supply chain management.
  • Understands the intricacies of working within cGMP and relevant health authority global regulations, FDA and EMA.
  • Review and update SOPs, develop necessary processes and procedures to support global supply
  • Develop and implement tools to forecast and track clinical supplies including inventory by SKU and expiry/retest dates to ensure inventory management practices
  • Develop and analyze full spectrum metrics to drive efficiency and improvements
  • Develop and manage plans for clinical packaging/labeling processes, shipping authorization, import/export licenses, cold chain global distribution, etc. to ensure continuity of supply
  • Manage budget, contractual obligations, purchase orders and invoices for clinical supply chain
  • Coordinate artwork and packaging design for printed packaging components through external suppliers for all markets

Commercial:

  • Build, develop and lead Sales and Operations Planning System (S&OP)
  • Plan and implement activities related to commercial supply chain, custom clearance, cost management, storage, warehousing, distribution, procurement, logistics, forecast, inventory control, data management, and production planning
  • Ensure the availability of commercial product inventory in the supply chain, as scheduled, and the maintenance of inventory at minimum acceptable levels and cost applying risk-based review of the supply chain
  • Coordinate with Third Party Logistics/Finance/Accounting for invoices and inventory carrying costs
  • Create and implement supply chain analytics, planning, and resilience processes and policy across the global supply chain at all stages of the product lifecycle
  • Contribute to a response plan for disruptive challenges such as accidents, natural disasters, extreme weather, geopolitical hazards, transportation disruption, and IT failures. Ensures that the plan and capabilities of each supplier are adapted, validated, and in place to minimize the risk of disruption and deliver an effective response to threats and hazards
  • Enhance a risk-intelligent enterprise culture by implementing risk-mitigation planning for supply chain management. Lead the design and implementation of training and awareness programs on business continuity, disaster preparedness, and related concepts

 

Qualifications and Professional Experience:

  • Minimum of 10 years of clinical and/or commercial manufacturing, supply chain and logistics work experience in the pharmaceutical industry
  • Minimum Bachelor’s Degree in Pharmaceutics, Pharmacy, Chemical Engineering, Biotechnology Engineering, Chemistry, Biochemistry, Biology
  • National and international travel will be required (25%)

 

Preferred Skills:

  • Commercial Pharmaceutical Manufacturing, Supply Chain, Logistics
  • Managing/interacting with Third Party Logistics, Client Services, Wholesale and Retail Warehouses, Customers, Vendors, Finance, Accounting
  • Supply Chain Data Analysis
  • Experience with ERPs
  • Skilled in Microsoft Office, including Outlook, Excel and PowerPoint

 

The above statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all responsibilities.

X4 Pharmaceuticals is an Equal Opportunity and Affirmative Action Employer committed to a culturally diverse workforce. All qualified candidates will receive consideration without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital, domestic partnership or civil union status, sex, gender identity or expression, sexual orientation, disability, veteran status, violence victim status or any other characteristic protected by law. Please send your resume and cover letter to careers@x4pharma.com.

We invite you to apply for any of our current openings at careers@x4pharma.com for additional employment related information.

Location: Vienna, Austria

Privacy Notice for applications of X4 Pharmaceuticals (Austria) GmbH in accordance with Article 13 of the General Data Protection Regulation (“GDPR”)
Scientist, Discovery

About X4 Pharmaceuticals

Our commitment is to find solutions for patients. Every day, we strive to advance our pipeline of innovative medicines to treat rare diseases. Our first-in-class, oral, small molecule therapeutics are antagonists of chemokine receptor CXCR4, which have the potential to treat a broad range of rare diseases, including primary immunodeficiencies (PIs) and cancer.

X4 Pharmaceuticals, Inc. was founded and is led by a team with deep product development and commercialization expertise, including several former members of the Genzyme leadership team and has its headquarter located in Cambridge, Massachusetts.

X4’s research and development facility in Vienna, Austria, X4 Pharmaceuticals (Austria) GmbH is located on Campus Vienna Biocenter (Helmut-Qualtinger-Gasse 2, 1030 Vienna) and is run by a team of highly motivated scientists and technicians who are dedicated to build a Center of Research Excellence in the field of small molecule therapeutics. X4 Pharmaceuticals (Austria) GmbH is currently offering a full-time employment contract for a Scientist – Discovery.

 

Summary of the position:

The Scientist – Discovery will contribute to the identification and validation of novel PID targets and therapeutics, with a focus on WHIM and severe congenital neutropenia. Main duties will be to:

  • Perform in vitro functional analysis of novel gene variants for expanding the WHIM patient population
  • Perform pathway analysis and genetic association studies
  • Identify new target gene/pathway candidates based on genetic screening and patient population data
  • Design, implement and develop in vitro and ex vivo assays for functional and pharmacological target validation
  • Develop high-throughput assays for candidate drug identification
  • Perform detailed mode of action studies to guide lead selection
  • Present data at internal and external meetings
  • Write reports and scientific publications

 

Qualifications and skills:

  • PhD in Biochemistry, Cell Biology, Genetics or Bioinformatics with at least two years of postdoctoral experience or corresponding biotech experience
  • Scientific rigor and strong analytical skills
  • Good understanding of immune disease pathways
  • Familiarity with bioinformatics workflows
  • Strong hands/on experience with genetic manipulation, mammalian cell culture and phenotypic studies
  • Experience with protein-protein interaction studies, FACS, confocal microscopy, iPSC handling and/or genetic data mining is beneficial
  • Ability to supervise and train laboratory staff

 

We are offering:

  • A strong, dedicated and multinational team of scientists and technicians
  • An open, transparent and collegial working environment
  • Opportunities for your personal development and to play a key role in a growing international research center
  • Opportunity to work at the interface of pre-clinical research and clinical translational science

In accordance with Austrian employment law, the minimum monthly gross salary for the position is EUR 3.428,19 which we are willing to adjust according to your qualifications, skills and expertise.

Please send your resume and cover letter in English to careers-vienna@x4pharma.com

Please read our X4 Pharmaceuticals (Austria) GmbH Privacy Notice for Applicants, which you will find on our website by following this link: https://www.x4pharma.com/careers/

We invite you to apply for any of our current openings at careers-vienna@x4pharma.com for additional employment related information.

 

X4 Pharmaceuticals does not review or control the content on the website to which this hyperlink connects and this hyperlink does not constitute an endorsement by X4 Pharmaceuticals of the content of any non-X4 Pharmaceuticals website.

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