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

Director, Clinical Operations, Oncology

X4 Pharmaceuticals is developing novel medicines designed to improve immune cell trafficking and restore healthy immunity in certain rare, genetic primary immunodeficiency diseases and lymphomas.

Our oral, small molecule therapeutics antagonize the C-X-C receptor type 4 (CXCR4) pathway which plays a central role in immune surveillance. We are leveraging our unique assets and understanding of the CXCR4 pathway to pursue a rare disease strategy for developing and commercializing new treatments for patients who lack effective treatment options.

X4’s most advanced product candidate, X4P-001, is in a Phase 2/3 clinical trial in patients with WHIM syndrome, a rare genetic, primary immunodeficiency disease. Clinical programs for X4P‑001 are also advancing in other rare, genetic immunodeficiency diseases, as well as in certain rare leukemias and lymphomas. Additional programs advancing in X4’s pipeline include another CXCR4 antagonist for primary immunodeficiencies and a CXCR4-targeted candidate that crossed the blood-brain-barrier that is designed specifically for the treatment of brain cancers, including glioblastoma multiforme (GBM).

Reporting to the Vice President, Clinical Operations, the Director, Clinical Operations is an experienced clinical leader focused on the successful management of multiple clinical programs in oncology. The incumbent will work independently and collaboratively in a variety of clinical meetings, projects, and tasks. The 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 Responsibilities:

  • Responsible for the successful management of oncology clinical programs by day-to-day CRO management
  • Acts as a liaison between CROs and establishes quality guidelines to ensure CROs are meeting standards in accordance to X4’s SOP
  • Provide strategic input on clinical operations pipeline and goals
  • Ensures timely responses to clinical site staff and all regulatory agencies
  • Develop working relationships with CROs, key investigators, and other key staff/vendors
  • Participate in protocol development as needed
  • Serve as a leader to proactively audit and inspect clinical operations activities for efficiency, quality, and progress
  • Work on related clinical operations documents and publications as needed
  • Collaborate with staff to identify study investigators and sites
  • Monitor study progress, data collection, and clean-up for all trials
  • Prepare study reports and updates for leadership meetings
  • Develop best practices and SOPs as needed

Qualifications and Professional Skills:

  • Bachelor’s Degree in the related field
  • 10+ years of relevant Clinical Operations experience in Biotech/Biopharma
  • Experience with NDA and BLA submissions
  • Familiar and comfortable with clinical operations concepts and operational practices and needs
  • History of successful management and interaction with CROs, vendors, and other external clients
  • Proven team member that can work unilaterally and collaboratively
  • Detail oriented and able to guide clinical operations improvements in a growing company
  • Experienced in FDA regulations and other international regulatory agencies
  • Prior experience managing direct report(s)
  • Proven track record of managing multiple projects and/or programs concurrently
  • Self-starter with a positive work ethic

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, Pharmaceutical Development

X4 Pharmaceuticals is developing novel medicines designed to improve immune cell trafficking and restore healthy immunity in certain rare, genetic primary immunodeficiency diseases and lymphomas.

Our oral, small molecule therapeutics antagonize the C-X-C receptor type 4 (CXCR4) pathway which plays a central role in immune surveillance. We are leveraging our unique assets and understanding of the CXCR4 pathway to pursue a rare disease strategy for developing and commercializing new treatments for patients who lack effective treatment options.

X4’s most advanced product candidate, X4P-001, is in a Phase 2/3 clinical trial in patients with WHIM syndrome, a rare genetic, primary immunodeficiency disease. Clinical programs for X4P‑001 are also advancing in other rare, genetic immunodeficiency diseases, as well as in certain rare leukemias and lymphomas. Additional programs advancing in X4’s pipeline include another CXCR4 antagonist for primary immunodeficiencies, and a CXCR4-targeted candidate that crossed the blood-brain-barrier that is designed specifically for the treatment of brain cancers, including glioblastoma multiforme (GBM).

Reporting to the Vice President, Technical Operations & Quality, the Director, Pharmaceutical Development is a highly visible role as a technical subject matter expert at X4. The successful candidate will be responsible for developing phase-appropriate formulations, drug product presentations and manufacturing processes for small-molecule drug candidates from research through registration, including technology transfers and process validation, and in collaboration with contract development and manufacturing organizations. The position requires in-depth pre-formulation, formulation and drug product manufacturing experience, as well as demonstrated operational and collaboration capabilities and experience interfacing with vendors and regulatory agencies. The successful candidate will participate on CMC Teams, lead technical teams, and collaborate seamlessly with other functions, including process chemistry, analytical, regulatory, quality and 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 Responsibilities: 

  • Plan and manage phase appropriate drug product formulation, process development and manufacturing at contract manufacturing organizations (CMOs) from research through development to commercialization to develop safe, robust, compliant, and cost-effective drug products for X4
  • As the primary subject matter expert, operate at a detailed technical level while keeping CMC and program milestones in mind to deliver on corporate and program goals within the prescribed budget
  • Build professional and long-term relationships with contract development and manufacturing organization personnel. Place appropriate value and focus on communication, planning, risk assessment, and as necessary, escalation of issues
  • Collaborate with Analytical, Process Chemistry, Supply Chain, Quality, and CMC Regulatory line functions as a critical and engaged member of the CMC Team. Lead cross-functional, internal, and external sub-teams as necessary.
  • Lead and participate in the writing and review of scientific reports and regulatory submission documents. Hold primary responsibility for the formulation, drug product development and manufacturing sections of global regulatory filings.
  • Review, document and archive data and reports from CMOs
  • Develop plans and manage the implementation of process validation and technology transfer activities to meet regulatory agency and quality expectations. Integrate quality by design and risk management principles.
  • Work cross-functionally across X4 to communicate drug product objectives and impact, and with the CMC Team Leader to integrate formulation, drug product development and broader CMC activities into program plans
  • Work directly with Analytical colleague(s) to establish and implement all analytical requirements for product development; and with process chemistry colleague(s) to integrate technical API information into formulation and drug product development activities.
  • Work with all members of the CMC Team to establish a complete pre-formulation and drug product characterization program, including stability. Deliver ongoing data as necessary to support continued development progress. Support clinical and nonclinical supply needs.
  • Interface with Commercial to develop appropriate drug product presentations to meet patient, health care providers and X4 needs.
  • Interface with pipeline program teams in the selection of lead candidate molecules. Work closely with internal and external colleagues to seamlessly move development candidates into the IND enabling stage.
  • Travel sufficient to develop and build strong partnerships with CMOs (estimated at approximately 15%).

 Qualifications and Professional Skills: 

  • MS or PhD with at least 10 years of accomplished experience in oral small molecule formulation, drug product and process development in the biotech/bio pharma industry.
  • Proven experience as a direct manager of people and/or manager of external teams.
  • A reputation for a patient-centric perspective in all business transactions
  • Technical depth and a broad understanding of formulation, drug product presentations and analytical development.
  • A proven track record of solving complex scientific and technical issues. Creativity in working through logistical challenges. Experience with Quality investigations is a plus.
  • Experience working with both early and late stage (phase 3, commercial) programs, including process validation, CPPs and QbD approaches. Strong experience in and knowledge of GMP and ICH requirements.
  • Significant experience working with CMOs through the various stages of drug development. Participating in vendor selection, developing scopes of work, participating in virtual teams, planning and reviewing technical content, leading technical and data-based decision making, negotiating plans, and holding CMOs accountable for delivery.
  • Demonstrated success leading and working in global, cross-functional teams.
  • Direct experience writing regulatory documents and interfacing with global regulatory agencies.
  • Demonstrated ability to meaningfully contribute to integrated CMC development strategy and to deliver on tactical implementation.
  • Strong leadership, team building, organizational, communication, and interpersonal skills. Able to apply a strategic view, as well as hands-on problem-solving skills.
  • Excellent verbal and written communication skills, ability to work across levels, functions and companies.
  • A strong team player that has a customer service approach and is solution oriented.
  • Demonstrates a sense of urgency, proactive thinking, and productivity in a fast-paced entrepreneurial 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, Statistics

X4 Pharmaceuticals is developing novel medicines designed to improve immune cell trafficking and restore healthy immunity in certain rare, genetic primary immunodeficiency diseases and lymphomas.

Our oral, small molecule therapeutics antagonize the C-X-C receptor type 4 (CXCR4) pathway which plays a central role in immune surveillance. We are leveraging our unique assets and understanding of the CXCR4 pathway to pursue a rare disease strategy for developing and commercializing new treatments for patients who lack effective treatment options.

X4’s most advanced product candidate, X4P-001, is in a Phase 2/3 clinical trial in patients with WHIM syndrome, a rare genetic, primary immunodeficiency disease. Clinical programs for X4P‑001 are also advancing in other rare, genetic immunodeficiency diseases, as well as in certain rare leukemias and lymphomas. Additional programs advancing in X4’s pipeline include another CXCR4 antagonist for primary immunodeficiencies, and a CXCR4-targeted candidate that crossed the blood-brain-barrier that is designed specifically for the treatment of brain cancers, including glioblastoma multiforme (GBM).

Reporting to the Chief Medical Officer, the Director, Statistics will be the key expert for statistical input into strategic clinical development planning across different therapeutic areas and design of translational and late stage clinical trials. This person will guide X4’s approach to data collection and data management standards and provide oversight of the external vendors/CROs executing data management and statistical analysis. The Director, Biostatistics will oversee the analysis, interpretation and reporting of clinical data and interface with the internal Data Science group to facilitate biomarker identification and data mining.

The successful candidate is a highly motivated Biostatistician with proven abilities and expertise in drug development, who will drive activities in support of timelines and budgets related to product development for all programs.

To succeed at X4, the candidate will have a sustained reputation for a values-driven, collaborative, engagement style where integrity and the consideration of our patients drives all decisions and actions. 

Scope of Work and Responsibilities:

  • Represent the statistics function in support of all X4 development activities.
  • Provide statistical analysis to feasibility assessments, development and submission plans, and in support of regulatory submissions.
  • Assure Statistical Analysis Plans are aligned with current regulatory guidelines.
  • Lead statistical support efforts with minimal supervision in the development and review of the statistical analysis plan, study report, and other analytical documents ensuring accurate and statistically valid deliverables.
  • Implement project level database (including derived database), analysis and reporting standards. Provide suggestions to achieve high quality databases and specifications by working with Data Management and Programming at project level.
  • Plan and direct study-level analysis and reporting activities (e.g., tables, listings, graphs) including review and sign-off of work by programmers.
  • Identify study-level vendor requirements and participate in the evaluation/selection of analytical vendors. Provide technical oversight of statistical activities of external vendors to ensure timeliness and quality of analysis data and statistical outputs. Review and approve key statistical vendor deliverables.
  • Anticipate and communicate study level resource and quality issues that may impact deliverables or timelines. Propose and implement solutions. Escalate issues to management, as appropriate.
  • Consider and evaluate alternative analysis methodology and data presentation techniques.

Qualifications and Professional Skills:

  • PhD in statistics/biostatistics with a minimum of 4 years of relevant experience or MS in statistics/biostatistics with a minimum of 6 years of relevant experience. For candidates with exceptional experience who have demonstrated the core capabilities of a Principal Statistician – 3 years of biotech/pharma experience with a PhD in statistics/biostatistics may be considered.
  • Experience with advanced study design or at least experience with one NDA/CTD or other global regulatory submissions.
  • Advanced knowledge of all phases of clinical study designs, common analysis methods, descriptive and inferential statistics.
  • Proven expertise and understanding of clinical drug development process, risks and associated documents.
  • Extensive knowledge of FDA and ICH regulations and industry standards applicable to the design and analysis of clinical trials and regulatory submissions.
  • Strong knowledge of statistical programming languages (including SAS), software, techniques, and processes. Working knowledge of UNIX operating systems, and common software products and technologies used in conjunction with SAS (e.g., Microsoft Office products).
  • Excellent oral, written and electronic communications skills.
  • Reputation for effective cross-functional project management and collaboration
  • Known for integrity and uncompromising professionalism

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, Regulatory Affairs

X4 Pharmaceuticals is developing novel medicines designed to improve immune cell trafficking and restore healthy immunity in certain rare, genetic primary immunodeficiency diseases and lymphomas.

Our oral, small molecule therapeutics antagonize the C-X-C receptor type 4 (CXCR4) pathway which plays a central role in immune surveillance. We are leveraging our unique assets and understanding of the CXCR4 pathway to pursue a rare disease strategy for developing and commercializing new treatments for patients who lack effective treatment options.

X4’s most advanced product candidate, X4P-001, is in a Phase 2/3 clinical trial in patients with WHIM syndrome, a rare genetic, primary immunodeficiency disease. Clinical programs for X4P‑001 are also advancing in other rare, genetic immunodeficiency diseases, as well as in certain rare leukemias and lymphomas. Additional programs advancing in X4’s pipeline include another CXCR4 antagonist for primary immunodeficiencies, and a CXCR4-targeted candidate that crossed the blood-brain-barrier that is designed specifically for the treatment of brain cancers, including glioblastoma multiforme (GBM).

Reporting to the Vice President, Regulatory Affairs, the Associate Director, Regulatory Affairs will be responsible for overseeing the global regulatory strategic plans for the development of current and future indications. The individual must possess excellent judgment, organizational and planning skills along with exceptional written and verbal communications. The successful candidate will also have the ability to influence and negotiate professionally at various levels within the project team and with 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 Responsibilities: 

  • Accountable and responsible for evaluating and ensuring that IND/IMPD/NDA and other filings meet all global regulatory requirements throughout the drug development process. Ensures that safety reporting requirements, annual reporting, and routine updates are met within the regulatory timeframes.
  • Represent regulatory affairs at various clinical trial team meetings and provide regulatory content reviews of clinical documents, such as new or revised protocols, patient informed consent forms, investigator’s brochures.
  • Lead the development and maintenance of global regulatory strategy documents and target product profiles to support new marketing application planning and development. Research regulatory precedence of prior approvals, clinical trial endpoints and compare competitor labeling documents.
  • Consistently and proactively research and learn FDA and EMA regulation, guidance and standards to anticipate and resolve regulatory and clinical development questions, as needed, throughout the drug development process. Provide timely dissemination of regulatory intelligence, as appropriate to continually educate and inform project team(s).
  • Translate and integrate strategies into the global regulatory submissions operations needs working with a vendor to ensure that all electronic submissions meet global regulatory standards, including the development of submission content plans, submission component development, compilation, and quality checks of documents prior to submission to regulatory agencies. Maintain and update regulatory files to ensure chronologies remain in good order and implement a system for tracking global IND/IMPD/NDA and other submissions and changes.
  • Responsible and accountable for communicating and driving timelines, risks, and ensuring that submission components are completed within the expected timeframe. Provide regulatory support in drafting responses to global agency requests for information, and briefing document development for Agency meetings, and ensure that next level management remains apprised of any changes to the plan along the way.
  • May supervise regulatory affairs consultants, as required.

Qualifications and Professional Skills: 

  • BA degree in a science discipline or related discipline
  • 5+ years of relevant experience within the Regulatory Affairs discipline of a life sciences company
  • Knowledge of US and international regulatory requirements
  • Marketing application submission experience, Agency interactions, and knowledge of orphan drug development are a plus
  • Demonstrated ability to think critically and analyze scientific information while paying close attention to detail

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.  

Assistant Corporate Controller & External Reporting

X4 Pharmaceuticals is developing novel medicines designed to improve immune cell trafficking and restore healthy immunity in certain rare, genetic primary immunodeficiency diseases and lymphomas.

Our oral, small molecule therapeutics antagonize the C-X-C receptor type 4 (CXCR4) pathway which plays a central role in immune surveillance. We are leveraging our unique assets and understanding of the CXCR4 pathway to pursue a rare disease strategy for developing and commercializing new treatments for patients who lack effective treatment options.

X4’s most advanced product candidate, X4P-001, is in a Phase 2/3 clinical trial in patients with WHIM syndrome, a rare genetic, primary immunodeficiency disease. Clinical programs for X4P‑001 are also advancing in other rare, genetic immunodeficiency diseases, as well as in certain rare leukemias and lymphomas. Additional programs advancing in X4’s pipeline include another CXCR4 antagonist for primary immunodeficiencies, and a CXCR4-targeted candidate that crossed the blood-brain-barrier that is designed specifically for the treatment of brain cancers, including glioblastoma multiforme (GBM).

Reporting to the Senior Director, Finance & Corporate Controller, the Assistant Controller will be responsible for managing the monthly accounting close and all SEC reporting and filings. The individual will be responsible for multi-tasking on many projects and deliverables.  This position will have senior executive exposure and will work with auditors, lawyers and other specialists on a regular basis.

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 Responsibilities: 

  • Directs the preparation, review, and submission, of financial statements and other filings as required by government and regulatory agencies including the US SEC
  • Manages the timely preparation and review of monthly, quarterly and year-end financial statements
  • Leads relationship and activities with external auditors as part of the financial reporting process
  • Implements and maintains with new accounting pronouncements under US GAAP
  • Administers company employee stock option plans and capitalization table
  • Preparation of financial materials and other materials used in presentations to the Audit Committee, Board of Directors and Senior Management
  • Assume the lead role in managing internal controls and compliance programs
  • Assist the Controller with all relevant corporate tax areas and be a liaison with the third-party accounting firm engaged in the corporate tax function
  • Proactively serve as a business partner to internal business units for financial report preparation and accounting close
  • Complete, document and communicate and/or present ad-hoc projects and analysis

Qualifications and Professional Skills: 

  • Bachelor’s degree in Accounting required with a minimum of 7 years’ experience working for a public company
  • Public accounting experience and CPA required
  • Experience in biotechnology or pharmaceuticals industries preferred
  • Technical expertise related to GAAP and external reporting including SEC reporting, stock-based compensation accounting, and internal control requirements
  • Demonstrated recent experience in researching and preparing technical accounting memorandums for complex issues and new pronouncements
  • Understanding of accounting policies, processes, procedures, and internal controls
  • Experience with general ledger functions and the month-end/year-end close process
  • Knowledge of automated financial reporting and accounting systems
  • Ability to adapt quickly and learn new tasks independently
  • Ability to manage competing priorities and in order to meet deadlines
  • Excellent verbal and written communication skills, ability to work across levels, functions, companies, and countries.
  • Demonstrates a sense of urgency, proactive thinking, and productivity in a fast-paced, entrepreneurial and team-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.  

We invite you to apply for any of our current openings at careers@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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