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

Director/Associate Director, Biostatistics, Rare Disease

Company Description:

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

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

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

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

Reporting to the Senior Director, Biostatistics, the Director/Associate Director, Biostatistics, Rare Disease will be responsible for providing leadership and oversee all biostatistics activities for one disease area or clinical program(s) to ensure valid and efficient statistical designs, accurate analyses, and timely delivery of reports and regulatory submissions. She/he builds and maintains strong collaboration with key stakeholders from different disciplines across the organization (e.g., Clinical Physicians, Clinical Operations, Regulatory, Medical Affair, and Safety teams) to develop agile and robust clinical development plans. She/he contributes to establishing and driving the strategy for resourcing, processes and standards operating procedures. This individual is responsible for the production of biostatistics deliverables as well as accountable for the strength of the partnership and the results of our external resources. She/he will be managing a team of external vendors: CRO’s, statisticians, stats programmers, data managers and will support the development of the internal biostatistics team accordingly. A successful candidate is an excellent communicator, self-motivated, and forward thinking.

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:

  • Oversee statistical support for phase II and phase III studies for rare disease program.
  • Collaborate with clinical and regulatory leads in defining strategic approach, creating clinical development plans (CDP), and producing individual protocols.
  • Provides strategic contributions to the clinical study programs, including study designs, protocol development, statistical analysis plans, data analysis and reporting, as well as key contributions to the planning and delivery of clinical components of regulatory submissions including INDs, NDAs and MAAs.
  • Manage the execution of statistical analyses; preparation of the statistical methods and results sections for clinical study reports (CSR), and production of overall summaries.
  • Serve as the statistical representative at cross-functional team meetings.
  • Responsible for completing CDISC requirements for SDTM and ADaM.
  • Develop and track project activities for phase II and III studies to ensure all timelines are met.
  • Provide lead oversight to vendor team to ensure quality and consistency of statistical deliverables.
  • Learn and apply techniques to promote teamwork, quality, and motivation. Ability to manage conflict, prioritize daily tasks and adapt to changes.
  • Keep abreast of innovative statistical methodologies in study design and analysis, industry standards, regulatory requirements, and internal SOPs.
  • Advocate application of statistical thinking in decision-making. Effective collaboration with leaders in other functional areas.

 

Qualifications and Professional Experience:

  • D/MS in Statistics or Biostatistics with a minimum of 7/10 years of pharmaceutical experience.
  • Substantial interactions with global regulatory authorities which include the FDA, EMA, and PMDA.
  • BLA/NDA/MAA submission experiences.
  • Demonstrated leadership, project management, adapting to changes, and effective partnership
  • Ability to explain methodology and consequences of decisions to a variety of audiences who do not have stats expertise.
  • Demonstrated experience developing effective and sustained partnerships with external partners, including CRO’s and Consultants.
  • Broad knowledge and application of advanced statistical concepts and techniques.
  • Extensive knowledge of major statistical software programs including SAS.
  • Exceptional oral, written, presentation, and communications skills.
  • Embrace our core values: Accountability, Excellence, Grit, Integrity, Sense of Urgency, and Camaraderie.

 

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 Director, Regulatory Affairs

Company Description:

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

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

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

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

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

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

 

Scope of Work and Accountabilities:

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

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

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

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

 

Qualifications and Professional Experience:

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

 

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

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

Senior Director, Toxicology

Company Description:

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

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

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

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

Reporting to the Senior Vice President, Research & Development, the Senior Director, Toxicology will be responsible for nonclinical safety studies. He/She will be responsible and accountable for the design and execution of all safety studies from discovery to early/late development projects. All interactions with CRO’s will be managed to ensure delivery of study results and reports consistent with project timeline. Additionally, he/she will be accountable for the delivery of proper documents for regulatory filings.

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:

  • Oversee nonclinical safety related project activities for X4’s small molecule products from discovery stage through regulatory filings and to commercialization.
  • Develop and oversee the execution of phase appropriate nonclinical safety strategies along with integrated project plans including milestones, timelines, resources and budgets.
  • Provide strategic contribution as the subject matter expert for GLP, non-GLP, and safety pharmacology studies.
  • Liaise and represent the company as the nonclinical safety expert before U.S. and European regulatory authorities
  • Drives and is accountable for delivery of audited and timely delivery of high-quality safety reports to enable clinical plans and regulatory filing submissions in multiple markets.
  • Identify, lead, manage, and build a long-term relationship with CROs for delivery of nonclinical safety studies for pharmaceutical candidates.
  • Reviews and provides expertise for all safety associated regulatory and quality documents associated with INDs, NDAs and other regulatory submissions and documentation
  • Creates the standard for compliance to meet and exceed regulatory requirements both internally and externally by ensuring CROs are using systems and processes in compliance with all relevant regulatory standards.
  • Serve at the toxicology representative as all cross-functional meetings both internally and externally
  • Responsible for forecasting and managing nonclinical safety program investment plans that align with business goals
  • Proactively manages risk and drives project related decisions to ensure teams are successful in achieving their goals and team milestones.

 

Qualifications and Professional Experience:

  • PhD in Pharmacology, Biology, Toxicology, or related scientific discipline
  • 10+years of experience in a pharmaceutical or biotechnology management of nonclinical safety activities for discovery and development programs
  • In-depth understanding of all aspects of nonclinical safety and experience with regulatory filings
  • Extensive knowledge of relevant FDA and EMEA regulations and processes
  • Demonstrated proven experience in working with and managing US and International CROs for protocol design and study execution
  • Ability to operate effectively within an entrepreneurial and science-driven company environment; self-motivated, delivery-oriented, assertive, able to inspire others, driven and
    hands-on with unquestionable integrity and the highest ethical standards.
  • Leadership experience with managing teams, budgets and resources to enhance business objectives

 

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 Director, Clinical Pharmacology

Company Description:

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

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

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

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

Reporting to the Senior Vice President, Research & Development, the Senior Director, Clinical Pharmacology will be responsible for setting the strategy across the portfolio and lead the Clinical Pharmacology function. The Clinical Pharmacology leader is a highly scientific role, supporting multiple facets of Clinical Pharmacology, including study design, PK and PK/PD analyses, and overall drug development support. He/She will have an excellent knowledge of Clinical Pharmacology principles, such as PK, PK/PD, drug metabolism, and DDI, as well as a good understanding of related disciplines such as pharmaceutical development, regulatory, and overall drug development. He/She will have demonstrated interpersonal skills, and be self-motivated, able to work well in cross-functional teams, and must have a strong work ethic and integrity. Additionally, he/she must possess outstanding communication skills (verbal, written and electronic) and be able to build strong relationships and influence decision-making, while managing tight timelines.

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

 

Scope of Work and Accountabilities:

  • Lead and direct human clinical pharmacology trials from Phases I–IV for all company products that are currently under development.
  • Review and provide expertise on all adverse event reporting and safety management, in collaboration with and under the direction of the Drug Safety/Pharmacovigilance Department.
  • Develop strong partnerships with cross functional senior key stakeholders to ensure that strategic business goals are met through the sharing of knowledge and teamwork.
  • Provide peer-reviewed interpretation of clinical pharmacology data and incorporate appropriate analyses into reports required for regulatory submissions.
  • Provide complex clinical pharmacology input to clinical development plans, Investigator’s Brochure and Clinical Pharmacology section of INDs, CTAs and/or NDAs with supervision.
  • Lead clinical pharmacology studies and collaborate on clinical studies for study conceptualization, protocol development, and study start-up activities, including site initiation and investigator meetings.
  • Develop and prepares all reports submitted to regulatory authorities specifc to all content in appropriate regulatory documents including clinical pharmacology sections of CTD format documents.
  • Serve as the subject matter expert for the scientific and technical input about clinical pharmacology-related issues within project teams, as assigned.

 

Qualifications and Professional Experience:

  • PharmD, or PhD with at least 10 years of bio/pharmaceutical industry drug development experience in clinical pharmacology.
  • In-depth Knowledge of small molecule drug development or relevant clinical experience is strongly preferred.
  • Proven experience and understanding pertaining to the requirements of the study design, conduct, analysis and report writing for regulatory submissions.
  • Demonstrated experience interacting with the Food and Drug Administration (FDA) and other regulatory agencies

 

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 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 Clinical Data Manager will be responsible for the 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 assist in managing 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:

  • Lead the development of all database and eCRF design for the Biostatistics department
  • 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 local and global CROs
  • 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 generating and 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, advanced degree a plus
  • Minimum six 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.

In-house Clinical Research Associate

Company Description:

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

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

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

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

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

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

 

Scope of Work and Accountabilities:

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

 

Qualifications and Professional Experience:

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

Preferred:

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

 

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

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

Director, CMC Program Management

Company Description:

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

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

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

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

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

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

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

 

Scope of Work and Accountabilities:

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

 

Qualifications and Professional Experience:

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

 

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

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

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

Location: Vienna, Austria

Head of Research

About X4 Pharmaceuticals

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

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

Our Research facility, X4 Pharmaceuticals (Austria) GmbH is located in Vienna, Austria and includes a team of highly motivated scientists and technicians who are dedicated to building a Research Center of Excellence.

X4 Pharmaceuticals (Austria) GmbH is currently offering a full-time employment contract for a Head of Research.

Reporting to the SVP, Research and Development in the corporate office in Cambridge, MA. USA, the Head of Research will expand the depth of talent and leadership on our science team and establish the research site in Vienna, Austria as a Research Center of Excellence. The successful candidate will be responsible for designing and executing research strategies to explore and understand the biology underlying primary immunodeficiency diseases and genetically defined cancers, as well as developing a discovery pipeline to identify new biological targets and small molecule therapeutics. X4 Pharmaceuticals is currently conducting a Phase 3 study with Mavorixafor in WHIM Syndrome and opening Phase 1b studies in severe congenital neutropenia and Waldenstroms Lymphoma. The Head of Research will bring a strong reputation and background in people management and in building and retaining strong teams. Scientific experience in drug discovery, immunology and sound knowledge of primary immunodeficiencies is required. A forward thinking, intellectually curious leader with prior leadership experience in industry who thrives in a team-oriented, fast-paced, and cross-disciplinary biotech environment is suited for success.

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.

 

Accountabilities include:

  • Expand the science team and establish X4’s research facility in Vienna, Austria as a leading Research Center of Excellence.
  • Ensure alignment with SVP, R&D and lead success to meet X4’s corporate goals and strategy
  • Coordinate and manage successful drug discovery efforts with the US and global Contract Research Organizations
  • Expand the translational science capability and work with the medical team in the US to profile patient derived genetic variants Lead and develop the science team by providing expert guidance, strengthen corporate scientific excellence and champion new biological targets to identify new potential research projects
  • Assure and execute timely and compliant financial planning and resources allocation
  • Establish and build long term research collaborations with academic partners, key opinion leaders and Contract Research Organizations
  • Disseminate scientific results in a timely and compliant manner through publications and scientific meetings

 

Qualifications and skills:

  • Ph.D. degree in immunology or a relevant area of biological science with 10+ years post-doctoral experience in the biotech or biopharma industry
  • Deep experience in adaptive and innate immunity, including immune cell activation, lymphocyte biology and cell signaling; sound knowledge in primary immunodeficiency disorders
  • Proficient in modelling immunodeficiency disorders ex vivo and in vivo
  • Translational science background with proven experience in preclinical and clinical development
  • Proven reputation as a strong leader and developer of people and teams
  • Strong business understanding, organizational skills including experience in project management, financial and resource planning
  • History of building a strong and reliable scientific network
  • Proven ability to inspire and lead creative and innovative thinking with talented research teams and collaborate effectively in multi-disciplinary teams
  • Reputation for scientific rigor and integrity
  • Scientific accomplishments in the field, including publications, patents and conference contributions, excellent verbal, written and electronic presentation and communication skills and command of written and spoken English (corporate language)
  • German language skills are an advantage, but not required

 

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.

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

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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