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 Scientist

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.

Reporting to the Senior Medical Director, Oncology, the Clinical Scientist contributes to the creation, design, planning, and execution of clinical development strategy and research projects. The Clinical Scientist works extensively with the Medical Director of Oncology, while collaborating with the Business Development, Data Management, Pharmacovigilance, Medical Writing, Medical Affairs, and Clinical Operations teams. On occasion, the work may expand to include support to the Rare Disease (WHIM) team.

The role is responsible for clinical trial design, clinical data analysis, internal and external communication of project information and plans, and contributions to regulatory submissions, publications, and presentations.  The successful candidate is capable of prioritizing and overseeing multiple clinical trials/studies, leading them from planning through the full cycle (concept to reports and manuscripts). The position may include assisting the Medical Director/Clinical Development Physician with external interactions with health authorities. 

Scope of Work and Responsibilities: 

  • Contribute to the design of clinical studies in close collaboration with the Medical Lead, as well as the Clinical Development team
  • Communicate with external medical/scientific advisors, thought-leaders, and clinical investigators in the therapeutic areas, as well as with internal management and drug development staff, to prepare/revise/maintain and efficiently execute the drug development plan
  • Support Medical Lead with safety reviews, site interactions and review of TFLs. Responsible for analytical support of clinical trial data (safety and efficacy), including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations to Medical Lead. Analyze and synthesize information to assess issues relating to protocol conduct and/or individual patient safety. Assist in communicating a clear overview of trial results.
  • In collaboration with Clinical Operations and the Medical Lead, review protocol deviations (PD) to identify cause and propose appropriate resolution. Review PD trends and take appropriate actions, as needed.
  • In collaboration with Clinical Operations and Data Management, monitor completeness, consistency and accuracy of data entry in the course of the clinical study
  • Interact with internal and external stakeholders (study sites, vendors, committees, etc.) in support of clinical trial objectives; respond to or triage questions for appropriate escalations
  • Support authoring and review of protocols, clinical study reports, IBs, ICFs, training documents, charters, and other clinical and regulatory documents under the direction of the Medical Lead
  • Proactively provide insight on emerging clinical/competitive trends; understanding competitive landscape and providing insights on strategic development pathways. Participate in open-source competitive intelligence and/or other market/industry assessment activities and projects
  • Participate in the identification of appropriate external parties such as: investigators and consultants
  • Develop and cultivate relationships with external partners such as clinical investigators, clinicians, and scientists
  • Review, summarize and prepare literature reviews, as needed
  • Support accurate preparation of scientific material for conference presentations or publications
  • Provide support to advisory boards, consultant meetings, and investigator meetings, including preparation and delivery of presentations
  • Proactively recommend and implement process improvements
  • Anticipate potential study problems and prepare contingency plans as needed
  • On occasion, absorb responsibilities outside the scope of core responsibilities

Qualifications and Professional Skills:

  • RN, MS, PhD or PharmD, with experience in clinical research and drug development (equivalent strongly preferred)
  • 2 – 4 years of experience in all phases of clinical trial planning, start up, conduct, reporting and publishing required in the Biotech/Biopharma industry
  • Extensive knowledge of the clinical development process is required and an ability to understand various phases and principles of study design
  • Experience in protocol development, study report preparation, Investigator Brochure preparation, and regulatory submissions
  • Working knowledge and thorough understanding of all relevant regulatory guidelines and standards (e.g. GCP, ICH, and FDA guidance documents), as well as practices and expectations of Quality within GCP
  • Successful history interacting with medical monitors, development operations, and clinical investigators
  • Highly analytical with strong problem-solving, organization and critical thinking skills
  • Strong interest and experience working with details and the ability to manage and prioritize multiple tasks, especially under aggressive timelines
  • Ability to work individually, within a multi-disciplinary team and with external partners
  • Excellent written, electronic and verbal communication skills and an ability to effectively communicate with diverse audiences
  • Ability to assimilate technical and scientific information quickly and proficient in Microsoft Office (Word, Excel, PowerPoint)
  • Proficiency in various clinical trial managements systems (CTMS) and databases.
  • Strong verbal and electronic presentation skills
  • Reputation for integrity, respect and strong team work

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, Clinical Operations, 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.

Reporting to the Chief Medical Officer/Vice President, Clinical Operations, the Director of Clinical Operations, Rare Disease 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 incumbent will have a mindset of putting the patient first and foremost, as well as have a values-driven leadership style where integrity and grit drive all behaviors, decisions, and actions.  

Scope of Work and Responsibilities: 

  • Responsible for the successful management of rare disease 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
  • Supervise and develop the Senior Clinical Research Associate

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, Process Chemistry

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 Director, Process Chemistry—reporting to the Vice President, Technical Operations and Quality—is a highly visible role as a technical expert at X4. The successful candidate will be responsible for developing phase-appropriate drug substance (API) 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 process chemistry experience in development and manufacturing settings, 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 pharmaceutical and analytical development, regulatory, quality, and supply chain.

Scope of Work and Responsibilities:

  • Plan and manage phase appropriate API process development and manufacturing at contract manufacturing organizations (CMOs) from research through development to commercialization developing safe, robust, compliant, and cost-effective API manufacturing processes.
  • As the primary X4 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, Formulation and Drug Product Development, 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 chemistry sections of global regulatory filings. Document and archive data and reports from CMOs.
  • Develop plans and manage implementation of process qualification, 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 process chemistry objectives and impact, and with the CMC Team Leader to integrate process chemistry and broader CMC activities into program plans.
  • Work directly with Analytical colleague(s) to establish and implement all analytical requirements for process development; and with Formulation 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 API characterization program, including stability. Deliver ongoing data as necessary to support continued development progress.
  • Interface with medicinal chemistry experts in the development of pipeline molecules and with pipeline program forums 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 small molecule process chemistry 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 chemical process 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 on 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.  

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 will report to the Senior Director of Clinical Operations and is responsible for supporting and managing clinical trials, 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 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, preferably as a CRA, Senior CRA, or CTA
  • 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.