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

Clinical Trial Manager

Company Description:  

X4 Pharmaceuticals is developing novel therapeutics designed to improve immune cell trafficking including the ability for T-cells to track and destroy cancer cells. Our small molecule drug candidates inhibit C-X-C receptor type 4 (CXCR4), a receptor overexpressed in many cancers. Inhibition of CXCR4 is designed to block non-cancerous immunosuppressive and pro-angiogenic cells from populating the tumor, disrupting the cancer microenvironment, and restoring normal immune surveillance functions. We are committed to advancing the field of cancer immunotherapy and immune disorders through innovation and investment in our proprietary clinical and preclinical pipeline.

The Clinical Trial Manager is responsible for leading and managing clinical trials, as well as all operational aspects around that including, but not limited to: leading the study team for clinical trial updates, resolving or escalating issues as needed, timeline management, and vendor coordination. This position will work cross functionally to ensure the company needs are prioritized, met, and communicated in a collaborative and timely manner internally and with external partners. The focus is on clinical  operations activities in oncology and/or rare primary deficiency disorders. The candidate will bring  strong experience and knowledge in trial and site management, vendor relations, and experience in the full cycle of study from start to completion (start-up through close out).   

Scope of Work and Responsibilities: 

  • Accountable for select aspects of clinical trial operations (invovlment in CRO selection, vendor management, site start-up, and timeline management)
  • Facilitate the request for proposal(s) process for selecting CROs or any new vendor and participate in the evaluation of potential services
  • Create or assist in the development and/or review of study documents (protocol, ICF, monitoring plan, study manuals, eCRFs, IVRS, etc.)
  • Owns study timelines and study status to proactively communicate any updates that may impact timelines, quality, and/or budget-related items
  • Timeline identification of issues and ensure they are escalated and communicated appropriately
  • Create, manage, and negotiate clinical site budgets
  • Monitors progress of site activation to deliver speedy site start up timelines
  • Review and approve vendor invoices for services provided and track any potential trends for out of scope items
  • Previous success in clinical site monitoring (review trip reports, create and review monitoring plan, and ensure compliance with the plan)
  • Assist in identifying clinical trial sites and contribute to site feasibility and site selection decisions
  • Lead and participate in various multi-disciplinarily project teams
  • Experience and strong history managing study vendors (CRO, Lab Vendors, PK vendors, Safety vendors) and known for professionally and diligently working with clinical study sites
  • Communicate study status both internally and externally in terms of study issues and mitigation plans, and develop proactive procedures to mitigate risk
  • Contribute or organize Investigator Meetings and CRA trainings
  • Lead risk assessment and identify any risk mitigation strategies as appropriate
  • Provide expertise to study drug and clinical supplies forecasting and help oversee proper drug accountability and reconciliation
  • Oversee maintenance of both the study team and vendors to appropriately file study documentation either in a Clinical Trial Management System (CTMS) or electronic Trial Master File (eTMF)
  • Contribute to any clinical trial or project audit and inspection readiness
  • Ensure compliance with clinical trials registry requirements as well as any applicable Standard Operating Procedures (SOPs)

Qualifications and Professional Skills: 

  • Bachelor’s degree in related field
  • 5+ years of relevant clinical research/operations experience in Biotech/Biopharma
  • Excellent organizational and time management skills
  • Demonstrated communication skills skillfully and clearly articulating timelines, deliverables, and study questions/issues in cross-functional and multi-level teams
  • Prior experience successfully managing and developing study documents
  • Known for proactive problem solving and success meeting deadlines and demonstrating effective use of time to meet priorities
  • Able to manage multiple projects simultaneously, in a fast changing environment
  • Knowledge of ICH/GCP and regulatory guidelines
  • Proven relationship and vendor management skills, with success moving through conflict
  • Ability to lead study teams and build cross-functional relationships internally and externally
  • Technical proficiency in MS applications such as Word, Excel, EDC, IVRS/IWR, etc.
  • Highly respected for commitment to integrity, professionalism and respect for patients

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-CMC

Reports to: VP, Regulatory Affairs & Quality Assurance

Company Description:

X4 Pharmaceuticals is developing novel therapeutics designed to improve immune cell trafficking including the ability for T-cells to track and destroy cancer cells. Our small molecule drug candidates inhibit C-X-C receptor type 4 (CXCR4), a receptor over-expressed in many cancers. Inhibition of CXCR4 is designed to block non-cancerous immunosuppressive and pro-angiogenic cells from populating the tumor, disrupting the cancer microenvironment and restoring normal immune surveillance functions. We are committed to advancing the field of cancer immunotherapy and immune disorders through innovation and investment in our proprietary clinical and preclinical pipeline.

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.

The Position:

X4 Pharmaceuticals is seeking an experienced Regulatory Affairs Chemistry, Manufacturing and Controls (Reg-CMC) professional who is a resourceful and integrative thinker for a highly visible role within a growing company.  This position will provide product development strategy and direction to the CMC and clinical teams and report to the VP, Regulatory Affairs and Quality Assurance.  The Reg-CMC leader will be responsible for ensuring that the regulatory strategy is aligned with global regulatory agency requirements and that expectations for development from pre-clinical to commercial phases are met with high quality.

Scope of Work and Responsibilities

  • Serve as the primary Regulatory-CMC representative and leader on project teams and committees, including leading meetings with regulatory agencies for all CMC-related matters (i.e., briefing document development, slide development, meeting coordination, team preparedness and response)
  • Provide strategic and tactical CMC regulatory guidance for global development and registration programs (i.e., IND, CTA, NDA, MAA), working closely within the CMC teams to plan, integrate and align global regulatory expectations for development and commercialization
  • Manage timelines & lead the compilation, review, and approval process of CMC documents intended for regulatory submission. Manage CMC submissions, including writing, QC, and formatting of appropriate sections of IND/IMPD and marketing application sections, including responses to regulatory agency requests for information, working collaboratively with subject matter experts in CMC tech ops, QA, global supply chain and other functions, as needed to ensure alignment of submission components
  • Assess and communicate CMC regulatory requirements to ensure all development activities are in compliance with applicable global regulations and guidelines
  • Manage and ensure compliance with all CMC reporting requirements, including management of the CMC change control process, tracking of global regulatory commitments, annual reports.
  • Manage consultants, contract staff and vendors, as needed to support regulatory activities

Qualifications and Professional Skills

The candidate must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.  Excellent interpersonal skills, experience developing strategic and long-term relationships with key stakeholders, tested conflict management and negotiation skills, and familiarity with Regulatory Operations are required.  The ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations is required. We are seeking someone with a demonstrated ability to translate strategy into action, excellent analytical skills, the ability to communicate clearly to a broad range of internal and external people, and experience in orchestrating plans resulting in resolution of issues and risk mitigation.

  • MS or BS degree with 5+ years of direct regulatory-CMC experience or combination of regulatory general/clinical and 3+ years of regulatory-CMC with demonstrated leadership skills
  • Experience leading and driving successful regulatory submissions, with first-hand knowledge of and experience interacting with FDA CMC regulatory teams
  • Deep understanding and demonstrated knowledge of eCTD elements and structure, including regulatory writing skills
  • Strong experience and knowledge of US regulations and ICH guidance related to Quality, principles, concepts, industry practices and standards
  • Successful history working collaboratively across departments and levels
  • Strong attention to detail with ability to understand the broader picture and priorities
  • Effective working individually and aligning within a multi-disciplinary team, as well as with external partners and vendors
  • Small molecule therapeutic technical background preferred
  • Embraces X4 core values

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. 

Qualified candidates please send cover letter and resume to careers@x4pharma.com

Medical Director, Clinical Development, Rare Disease

Company Description:

X4 Pharmaceuticals is developing novel therapeutics designed to improve immune cell trafficking including the ability for T-cells to track and destroy cancer cells. Our small molecule drug candidates inhibit C-X-C receptor type 4 (CXCR4), a receptor over-expressed in many cancers. Inhibition of CXCR4 is designed to block non-cancerous immunosuppressive and pro-angiogenic cells from populating the tumor, disrupting the cancer microenvironment and restoring normal immune surveillance functions. We are committed to advancing the field of cancer immunotherapy and immune disorders through innovation and investment in our proprietary clinical and preclinical pipeline.

The position:

Reporting to the Chief Medical Officer, the Medical Director, Clinical Development, Rare Disease is responsible for developing and implementing the global clinical strategy and tactical plans in a rare primary immunodeficiency disease program. As an emerging leader and content expert in our disease, WHIM (Warts, Hypogammaglobulinemia, Infections and Myelokathexis) Syndrome, the person will identify and learn from the WHIMS’ medical and patient communities to inform and execute our plans. Along with the Senior Director, Medical Affairs the person will engage and establish credibility with the medical community and lead this program to ensure strategic alignment and execution of internal and external priorities and activities. This position ensures rigorous scientific interactions with investigators, KOLs, and global regulators.

This is a unique opportunity to have a huge impact on a population of patients who are often undiagnosed or misdiagnosed. The successful candidate must be a leader who is a passionate drug developer driven to help patients, can inspire both internally/externally, has a creative mindset, is able to effectively succeed in ambiguity and has the appetite to grow with the organization.  This role also offers a high level of visibility across the leadership team and will have an impactful role on X4’s most advanced program.

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 or Work and Responsibilities:

  • Serve as primary Medical and Clinical lead for the Immunodeficiency Program. Lead, develop and implement the rare disease medical strategy through strong engagement internally and learning from the medical and patient communities.
  • Lead, develop and implement the Phase 2/3 study for WHIM.
  • Proactively identify program risks, and create and implement mitigation strategies.
  • Accountable for the day-to-day clinical, medical and scientific questions from various internal and external sources.
  • Participate in the ongoing interpretation and analysis of clinical trial results including human pharmacokinetics, pharmacodynamics, laboratory and biomarker data, review and approve clinical trial coding, and safety monitoring.
  • Collaborate cross-functionally in the preparation of the CDP, briefing books for health authority interactions, clinical protocols, investigator brochures, target product profiles, annual IND reports, severe adverse advent reports, periodic safety update reports, clinical study reports.
  • Participate as medical lead in various meetings with the EMA and FDA, or other regulatory bodies.
  • Timely reviews and analysis of the pertinent medical (disease-specific) literature.
  • Work with Senior Director, Medical Affairs to prepare and/or deliver abstracts, posters, and slide presentations at external Conference Symposia, and manuscripts for peer-reviewed journals.
  • Collaborate with Senior Director, Medical Affairs in representing X4 at global medical and advisory meetings, conferences and advisory boards; collaborates with thought leaders to ensure the integrity of information exchange and to significantly increase the X4 fingerprint in the communities.

Professional and personal profile: 

  • MD is required, board certification in immunology a plus
  • Highly accomplished and credible clinical development background within the biotech or pharma industry, experience in rare diseases preferred
  • Demonstrated ability to meaningfully contribute to development strategy and own and deliver on tactical implementation of strategy
  • Successful history working effectively with FDA and other global regulatory agencies
  • Experience leading and managing clinical development programs up to Phase 3
  • Exemplary written, verbal and electronic communications skills with diverse audiences
  • Proven success working with and effectively supporting cross-functional teams
  • Reputation for a collaborative and transparent leadership style
  • Strong analytical approach to problem solving
  • Knowledge of global regulatory climate
  • Reputation for rigorous science and highest ethics

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. 

Qualified candidates please apply to careers@x4pharma.com

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