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, Pharmacovigilance Operations

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, oncedaily, oral inhibitor of CXCR4, currently in a Phase 3 clinical trial 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 syndrome 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. Mavorixafor was recently granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with WHIM syndrome, and was granted orphan drug status by the FDA in 2018 and by the European Comission in 2019 for the treatment of WHIM syndrome.

Mavorixador is also being developed by X4 to treat Severe Congenital Neutropenia (SCN), Waldenström’s macroglobulinemia (WM), and clear cell renal cell carcinoma (ccRCC).

Reporting to the Vice President, Clinical Operations, the Senior Director, Pharmacovigilance Operations will be responsible for creating, directing and managing the company’s infrastructure to support the operational aspects of the pharmacovigilance system and adheres to all global safety requirements and internal processes and procedures. He/She will have experience in and perform multiple activities related to X4 case management, data review and assessment, document development and review including procedures for the accurate and timely processing, review and reporting across the portfolio. In addition, this position will build and maintain sustained and trusting relationships with key strategic internal and external stakeholders, including leadership for interactions with health authorities, support review and development of regulatory submissions and PV activities.

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.

This position is located in Cambridge, MA and does not include a relocation package. Qualified out-of-state applicants are responsible for their relocation.

Scope of Work and Accountabilities:

  • Drive and lead the building, developing and managing of external resources allocated to operational PV activities (i.e. Safety Vendor, CROs), creating a highly efficient, team to include insourced and outsourced resources, as needed.
  • Contribute to the development of global Medical Safety/Pharmacovigilance strategies.
  • Responsible for supporting regulatory submission activities related to safety (i.e. Overview and Summary of Clinical Safety).
  • Build, implement and ensure regulatory compliance with domestic and international pharmacovigilance systems, regulations, and industry standards.
  • Identify, Select and build strong relationships with PV vendors to support the current outsourced PV business model. Provide vendor oversight and management for all PV activities, including establishing and monitoring key quality and compliance metrics.
  • Establish a system for prevention and timely correction of deviation to compliance with stakeholders, in collaboration with the PV Quality, Compliance and Safety Systems group and QA team. Support development of functional area SOPs/WIs/Company Safety Governance Policy.
  • Oversee the set-up of new safety projects, including development of study-specific Safety Management Plans and set up of safety systems and database configurations in the PV database to accommodate these trials and products.
  • Develop and maintain a set of SOPs related to the processing and reporting of SAEs from clinical trials and marketed products, when relevant to ensure performant and compliant PV processing,  integrated with other PV and non- PV SOPs.
  • Contribute to the signal detection, benefit-risk profile assessment and aggregate reporting activities as requested.
  • Responsible for compliant and quality execution of all operational activities related to case management and related activities. Oversee timely submissions of expedited and periodic safety reports to the FDA & other health authorities. Lead authorship and cross functional review of developmental safety update reports (DSURs).
  • Identifies deviations and applicable corrective and preventive actions immediately to maintain the compliance reporting at its highest level.
  • Develop and implement an inspection readiness program with the contribution of other PV and non-PV stakeholders.
  • Ensure that the PV Database supports the department needs, including specific workflows and reporting/querying functionalities. Provide oversight of systems and MedDRA updates in
    collaboration with the relevant PV Vendor.

 

Qualifications and Professional Experience:

  • Bachelor’s degree in life sciences, pharmacy, nursing or equivalent health experience; advanced Life Sciences Degree or MBA preferred.
  • Minimum of 8 – 10 years of experience in Drug Safety / Pharmacovigilance role in the biotech or pharmaceutical industry.
  • Demonstrated ability to create, evaluate and maintain effective business processes, implement procedures, systems and tools to maximize budget and resources within a Drug Safety department.
  • Thorough knowledge and experience in all aspects of global safety reporting for clinical trials through commercialization.
  • Proven experience with currently available drug safety database systems, document management systems and QC tools. This also includes MedDRA and linked technologies.
  • Operational expertise with safety databases such as ARGUS is preferred.
  • Deep knowledge in supporting regulatory agency meetings and/or inspections is a plus
  • Strong interpersonal, collaboration and leadership skills and demonstrated ability to motivate

 

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 Regulatory Affairs 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, Regulatory Strategy and Operations, the Senior Regulatory Affairs Associate will be responsible for daily operations activities for global regulatory submissions across both the oncology and rare disease indications. The Senior Regulatory Affairs Associate will work collaboratively with the Regulatory Affairs team along with the Cross Functional teams to manage all aspects of the submission, from authoring documents to final submission of documents to global health authorities, utilizing an external publishing vendor.

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.

This position is located in Cambridge, MA and does not include a relocation package. Qualified out- of- state applicants are responsible for their relocation.

 

Scope of Work and Responsibilities:

  • Responsible for the day to day regulatory operations function working with the development teams to plan, develop, compile and publish submissions in accordance with regional requirements throughout the product lifecycle for all indications.
  • Collaborate and develop strong relationshiops with external vendors to formally publish all submissions via eCTD or other methods, as appropriate with health authority requirements, to ensure on time delivery of submissions.
  • Responsible for preparing accurate safety reporting submissions and ensuring all global safety requirements are met.
  • Proactively perform quality checks on all documents throughout drafting up until final submission to health agencies.
  • Maintain global regulatory files and chronologies to ensure chronologies remain in good order; formal submissions and other correspondences.
  • Collaborate with functional leads to ensure all submission documents are compliant with regulatory and company guidance/template specifications.
  • Create and drive timelines ensuring tracking deliverables are met against deadlines.
  • Proactively anticipate and communicate any potential risks identified that may derail timelines and propose risk mitigation strategies and execute, as needed.
  • Attend Cross Functional Team meetings to communicate timelines related to submission contents to ensure timely transmission to appropriate health authorities.
  • Track regulatory submission activities and provide forward looking submission planning for ongoing programs.
  • Author study transfer of regulatory obligations (TOROs) documents annually and lead team review/updates.
  • Facilitate the review of technical regulatory documentation and recommend changes to documentation or processes, including SOPs for regulatory compliance.
  • Regulatory representative for applicable clinical and regulatory study meetings and assist in compiling documentation to support clinical, regulatory and pharmacovigilance operations.
  • Work with Regulatory Affairs supervisors to define regulatory strategy.
  • Review new regulatory guidance’s/issues, disseminate information and evaluate the potential impact on projects and timelines.
  • Assist with various projects as needed.
  • Provide support to senior Regulatory Affairs staff and management as needed.

 

Qualifications and Professional Experience:

  • Bachelor’s degree in Life Sciences or Healthcare discipline.
  • 2+ years of relevant Regulatory Affairs experience working in a biotechnology or pharmaceutical environment managing various submissions.
  • Advanced expertise using Microsoft Office Suite (Outlook, Word, PowerPoint, Excel, SharePoint), Adobe Acrobat Professional, and eCTD content templates (e.g., Starting Point).
  • Maintain current knowledge of international regulations, guidance and standards applicable to X4 products.
  • General understanding of the drug development process.
  • Ability to manage multiple projects in a fast- paced environment with the ability to adapt to moving deadlines and priorities.
  • Motivated, highly detail oriented, self-starter with the ability to work autonomously and in a multilevel, cross functional team setting to achieve company goals.
  • Excellent interpersonal and intercultural communication skills, both written and verbal.
  • Strong software troubleshooting skills highly desirable.
  • Experience working with external publishing vendors desired.

 

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 Medical Science Liaison – West Coast

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 a Phase 3 clinical trial 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 syndrome 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. Mavorixafor was recently granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with WHIM syndrome and was granted orphan drug status by the FDA in 2018 and by the European Commission in 2019 for the treatment of WHIM syndrome.

Mavorixador is also being developed by X4 to treat Severe Congenital Neutropenia (SCN), Waldenström’s macroglobulinemia (WM), and clear cell renal cell carcinoma (ccRCC).

Reporting to the Vice President, Medical Affairs, the Medical Science Liaison is/will be responsible for providing non-promotional scientific, educational, and research support for X4’s Rare Disease and oncology portfolio. The MSL is a field-based scientific and clinical expert who strategically supports the medical and scientific objectives of X4’s development and marketed programs. S/he will be responsible for communicating the science and clinical application of X4’s molecules across all therapeutic areas to Healthcare Practitioners (HCPs). This individual will ensure the delivery of cutting edge clinical and scientific data and technical/practical education to practicing clinicians, key thought leaders, professional societies, and payers. S/he will also be responsible for gathering appropriate and relevant scientific insights from KOLs in an expeditious manner that will aid in strategic planning, enhance the quality of clinical research, increase the accuracy of assessments, and improve the positioning of X4 in the therapeutic areas of interest.

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:

  • Within respective geography, identifies, develops, and maintains effective professional relationships with critical external stakeholders to build a network of Key Opinion Leaders for research initiatives, scientific advisory boards and other opportunities for medical and scientific collaboration.
  • Develop and implement a comprehensive disease awareness plan within the respective geography including roundtables, grand rounds and other educational initiatives.
  • Partner closely with investigators and internal stakeholders for clinical trial enrollment and site identification.
  • Provide in-depth drug and disease state information to health care providers in the respective geography.
  • Attend key medical congresses at the national level and regional society meeting supporting scientific and corporate goals.
  • Remain up to date on relevant science and competitive landscape.
  • Serve as a liaison to health care professionals and professional organizations and disease state advocacy groups. Support the efforts of patient support groups and educational foundations.
  • Provide medical and scientific input into the planning and execution of advisory boards and MSL roundtables. Work with KOLs to review presentations and provide additional medical education where requested.
  • Respond to unsolicited requests regarding interest in investigator sponsored studies (ISS) and support their submission through appropriate internal process.
  • Accountable for meeting corporate goals and objectives while keeping in compliance with applicable policies and regulations.
  • Require 60-70% travel.

 

Qualifications and Professional Experience:

  • PharmD, PhD, MD preferred, but will consider NP/PA/MSN with clinical experience.
  • Minimum 8 -10 years of MSL experience (or equivalent).
  • Rare Disease and/or Oncology experience preferred, but not required.
  • Creative problem-solver with strong business acumen and skills.
  • Exceptional time management and organizational skills.
  • Proven track record of success in establishing relationships with opinion leaders.
  • Ability to understand and clearly communicate evidence based scientific information.
  • Ability to work collaboratively and cross-functionally showing sound decision making and accountability.
  • Experience in clinical research, patient recruitment, and investigator sponsored trials.
  • Passionate about making a meaningful difference in patient care.

 

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 Clinical Data Manager

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, Biometrics the Senior Clinical Data Manager will be responsible for all clinical data activities across X4’s innovative portfolio. He/She will be proficient in various tools to collect, clean-up, review, and report the data in a timely and accurate fashion. Additionally, the Clinical Data Manager will manage global CROs and will act as an internal expert in all areas of CDM processes and technology.

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:

  • Drive and lead the development of all database and eCRF design
  • Plan, develop and implement UAT (user acceptance testing), data specifications, data entry guidelines, CRF completion guidelines, and related operational manuals/guidelines
  • Develop and execute data validation guidelines and measures to ensure accurate data gathering from clinical studies
  • Review and provide expertise on all eCRF changes, respond accordingly to make resulting database changes
  • Organize and direct the initial stage of the studies, review and sign off on various items such as eCRF, data validation, data review guidelines, and data management plans
  • Collaborate and build strong sustainable relationships with multiple global CROs along with managing the process and coordination of each
  • Accountable for ensuring all data quality and timeliness of CDM deliverables are met and aligned with the business goals
  • Review, track and report status of all data management project(s) to senior leadership
  • Responsible for managing the clinical trial data queries along with the planning and execution of medical coding and SAE reconciliation
  • Maintain data integrity in compliance with GCP, relevant SOPs and regulatory requirements by reviewing data processes and filing documentation in the trial master file (TMF)
  • Develop strong partnerships with cross functional key stake holders to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting
  • Formulate and develop data management SOPs and processes that align and address business priorities
  • Reputation for data integrity and compliance

 

Qualifications and Professional Experience:

  • Bachelor’s degree required within a scientific discipline, advanced degree a plus
  • Minimum eight years of experience within biotech/biopharma and/or CRO organization
  • Extensive knowledge and experience in clinical data management
  • Direct experience with different Data Management systems and technologies, Electronic Data Capture systems and CDISC data standards
  • Extensive knowledge reviewing study planning documents such as Edit Check Specs, UAT scripts, Data Management Plans
  • Comprehensive understanding of database and dictionary structures (e.g., MedDRA, WHO DRUG)
  • Deep understanding of drug development, study conduct processes, GCP and regulations related clinical data management as well as ICH guidelines, FDA/EU regulations

 

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 Regulatory

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, oncedaily, oral inhibitor of CXCR4, currently in a Phase 3 clinical trial 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 syndrome 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. Mavorixafor was recently granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with WHIM syndrome, and was granted orphan drug status by the FDA in 2018 and by the European Comission in 2019 for the treatment of WHIM syndrome.

Mavorixador is also being developmed by X4 to treat Severe Congenital Neutropenia (SCN), Waldenström’s macroglobulinemia (WM), and clear cell renal cell carcinoma (ccRCC).

Reporting to the Senior Vice President, Regulatory Affairs the Director, Regulatory CMC will be
responsible for providing regulatory CMC related product development strategy and direction to the
CMC, clinical, nonclinical, and quality teams. The Reg-CMC leader will be responsible for ensuring that
the regulatory strategy is aligned with global regulatory agency(ies) requirements and expectations for
development at varying preclinical to commercial phases are met with high quality.

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. This position is located in Cambridge, MA and does not include a relocation package. Qualified out- of- state applicants are responsible for their relocation.

 

Scope of Work and Accountabilities:

  • 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 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 expectations for development and commercialization. Define strategies to mitigate risks.
  • 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
  • Keep abreast of new FDA / EMA regulatory requirements, as well as those from other key International regulatory authorities.
  • Act as the principal CMC, RA liaison with the FDA for original product approvals, maintenance and negotiations.

 

Qualifications and Professional Experience:

  • MS or BS degree in a scientific discipline with 10+ years of pharmaceutical development experience, including 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 and European 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.
  • Strong understanding of the CMC disciplines, technical development and manufacturing, quality and supply chain and experience working on CMC Teams.
  • 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.

 

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 Accountant

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 a Phase 3 clinical trial 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 syndrome 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. Mavorixafor was recently granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with WHIM syndrome, and was granted orphan drug status by the FDA in 2018 and by the European Comission in 2019 for the treatment of WHIM syndrome.

Mavorixador is also being developmed by X4 to treat Severe Congenital Neutropenia (SCN), Waldenström’s macroglobulinemia (WM), and clear cell renal cell carcinoma (ccRCC).

Reporting to the Senior Accounting Manager, the Senior Accountant will have responsibility for the payroll process as well as other day-to-day operations of the Finance department including the cash process, debt & lease accounting and equity administration. S/he will assist with other activities, such as implementation of controls in preparation for SOX compliance, as well as providing select, confidential administrative work with the Human Resources department. The position requires professionalism and discretion, the ability to multi-task while delivering high quality work, and the capability to work effectively in a rapidly changing environment. S/he will interact closely with all levels of management and staff, as well as outside service providers (vendors, consultants, attorneys, etc.). To succeed at X4, the position requires a strong professional to convey their values-driven, collaborative, engagement style where integrity and the consideration of our Patients drives all decisions and actions.

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.

This position is located in Allston, MA. and does not include a relocation package. Qualified out-of-state applicants are responsible for their relocation.

 

Scope of Work and Accountabilities:

  • Manage the complete payroll process, including regular and special payrolls, all timely changes to payroll, and reconciling payroll to the general ledger
  • Assist the Assistant Controller with Equity Administration for all plans and transactions
  • Contribute in the quarterly and year-end audit process including managing materials to support audit requirements/requests and interacting with auditors
  • Responsible for the preparation of journal entries and reconciliations as they relate to Lease and Debt Accounting
  • Research and prepare monthly bank reconciliations to ensure accuracy and timeliness
  • Support the Director of FP&A with monthly cash forecasts and reports
  • Build strong cross functional relationships with Human Resources to ensure timely and accurate employee transactions and to provide ad hoc confidential support (PTO tracking, benefits administration, etc.)
  • Support and maintain compliance across the company including tax filings, implementation of controls, debt compliance and governance
  • Create and update policies and process documents as needed
  • Help and assist with potential system implementations and upgrades including ERP, HRIS, or Payroll

 

Qualifications and Professional Experience:

  • Bachelor’s degree in Accounting or Finance, CPA preferred
  • 5+ years of experience, public accounting and/or life science/biotech preferred
  • Understanding of Sarbanes-Oxley (“SOX”) documentation and requirements
  • Broad knowledge of accounting principles (“GAAP”)
  • Strong expertise with ERP systems and advanced skill and experience in Excel
  • Proven experience using payroll systems, ADP preferred
  • Outstanding verbal, written and technology communication skills successfully working with all levels of the organization; high proficiency with Microsoft Office suite (PowerPoint, Excel, and Word)
  • Demonstrated ability in time management, attention to detail and organizational skills
  • Strong attention to detail with ability to understand the broader picture and priorities

 

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”)

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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