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, 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.

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.  

Associate Director, Clinical Operations, 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).

The Associate Director, Clinical Operations is an experienced clinical leader focused on the successful management of global programs in rare disease. The incumbent will work independently and collaboratively in a variety of clinical meetings, projects, and tasks. The Associate Director is an integral member of the Clinical Operations team and is a forward thinker looking to advance the mission and values of X4.

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

 

Scope of Work and Accountabilities:

  • Responsible for the successful management of the rare disease clinical programs by day-to-day CRO management
  • Act as the liaison between CRO’s and establish quality guidelines to ensure CRO’s are meeting standards in accordance to X4’s Standard Operating Procedures
  • Provide strategic input on clinical operations pipeline and goals that align with the business needs
  • Ensure timely responses to clinical site staff and all regulatory agencies
  • Develop close relationships with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships; lead planning and conduct of investigator’s meetings
  • Collaborate with cross-functional counterparts to oversee the performance for all activities assigned to our strategic partners, CROs and other vendors, including escalation of issues to governance committees and to senior management when warranted
  • Serve as a leader to proactively audit and inspect clinical operations activities for efficiency, quality, and progress
  • Provide expertise on related clinical operation documents and publications as needed
  • Develop and improve already existing clinical operations guidelines within the organization
  • Monitor study progress, data collection, and clean-up for all clinical trials
  • Participate in clinical operations department initiatives including preparation, review, and training of SOPs
  • Prepare and present clinical development trial updates to project teams and management and review any potential issues or recommendations

 

Qualifications and Professional Experience:

  • Bachelor’s Degree in Life Sciences or Healthcare discipline
  • 7-12 years of relevant Clinical Operations experience in Biotech/Biopharmaceutical industry
  • Experience with NDA and BLA submissions as well as FDA regulations and other international regulatory agencies
  • Deep knowledge with clinical operation concepts and operational practices
  • Proven experience of successful management and interaction with CROs, vendors, and other external clients
  • Proven track record of managing multiple projects and/or programs concurrently
  • Ability to effectively represent functional expertise at a cross-functional team level
  • Understand the concepts and implementation of budget development

 

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, Supply Chain and Logistics

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, Technical Operations & Quality, the Director, Supply Chain and Logistics will initially be responsible for managing the clinical supply chain for our current global blinded Phase III study and several new and ongoing open-label clinical studies. This role will expand over the next year to include the strategic and operational aspects of building and managing a commercial supply chain.

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

 

Scope of Work and Accountabilities:

Clinical:

  • Responsible for clinical supply continuity and risk management processes. Owning/and or assessing supply chain plans and inventories used to support both blinded and open label clinical supplies
  • Drive and Lead cross functional partnerships with Quality, Regulatory, Technical and Clinical partners
  • Collaborates with Clinical Operations to forecast initial and ongoing clinical drug supply needs and demand assumptions (enrollment rates, number of sites, number of countries etc.,) and assure successful start-up of and distribution to clinical sites
  • Represents Supply Chain on the CMC Team. Collaborates with Technical Operations to ensure drug substance and drug product availability, appropriate storage, shipment and handling instructions. Manage temperature excursions and handling deviations
  • Partners with Quality Assurance to enable global acceptance of clinical trial material and ensure compliance across all stages of clinical supply chain management.
  • Understands the intricacies of working within cGMP and relevant health authority global regulations, FDA and EMA.
  • Review and update SOPs, develop necessary processes and procedures to support global supply
  • Develop and implement tools to forecast and track clinical supplies including inventory by SKU and expiry/retest dates to ensure inventory management practices
  • Develop and analyze full spectrum metrics to drive efficiency and improvements
  • Develop and manage plans for clinical packaging/labeling processes, shipping authorization, import/export licenses, cold chain global distribution, etc. to ensure continuity of supply
  • Manage budget, contractual obligations, purchase orders and invoices for clinical supply chain
  • Coordinate artwork and packaging design for printed packaging components through external suppliers for all markets

Commercial:

  • Build, develop and lead Sales and Operations Planning System (S&OP)
  • Plan and implement activities related to commercial supply chain, custom clearance, cost management, storage, warehousing, distribution, procurement, logistics, forecast, inventory control, data management, and production planning
  • Ensure the availability of commercial product inventory in the supply chain, as scheduled, and the maintenance of inventory at minimum acceptable levels and cost applying risk-based review of the supply chain
  • Coordinate with Third Party Logistics/Finance/Accounting for invoices and inventory carrying costs
  • Create and implement supply chain analytics, planning, and resilience processes and policy across the global supply chain at all stages of the product lifecycle
  • Contribute to a response plan for disruptive challenges such as accidents, natural disasters, extreme weather, geopolitical hazards, transportation disruption, and IT failures. Ensures that the plan and capabilities of each supplier are adapted, validated, and in place to minimize the risk of disruption and deliver an effective response to threats and hazards
  • Enhance a risk-intelligent enterprise culture by implementing risk-mitigation planning for supply chain management. Lead the design and implementation of training and awareness programs on business continuity, disaster preparedness, and related concepts

 

Qualifications and Professional Experience:

  • Minimum of 10 years of clinical and/or commercial manufacturing, supply chain and logistics work experience in the pharmaceutical industry
  • Minimum Bachelor’s Degree in Pharmaceutics, Pharmacy, Chemical Engineering, Biotechnology Engineering, Chemistry, Biochemistry, Biology
  • National and international travel will be required (25%)

 

Preferred Skills:

  • Commercial Pharmaceutical Manufacturing, Supply Chain, Logistics
  • Managing/interacting with Third Party Logistics, Client Services, Wholesale and Retail Warehouses, Customers, Vendors, Finance, Accounting
  • Supply Chain Data Analysis
  • Experience with ERPs
  • Skilled in Microsoft Office, including Outlook, Excel and PowerPoint

 

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.

 

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 relationships 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 Skills:

  • 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.

Associate Director, Statistical Programming

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 Director, Biostatistics , the Associate Director, Statistical Programming is/will be primarily responsible for overseeing statistical programming activities across X4’s portfolio, managing CROs, providing hands-on programming support and technical guidance on clinical trials and regulatory submissions, building and maintaining programming infrastructure, and ensuring compliance with SOPs to produce quality and timely deliverables. He/she must possess extensive experience and proven skills in the use of SAS and complete knowledge and understanding of the statistical programming processes, procedures, and roles. He/she will use knowledge of CDISC SDTM and ADaM standards to statistical analysis, including generating analysis data, tables, and figures and create all files necessary to support an electronic submission in the eCTD format. Additionally, this individual will participate in departmental and cross functional technology development and process improvement initiatives.

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:

  • Effectively design and develop SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS.
  • Develop and deliver CDISC and regulatory compliant SDTM, and ADaM standard datasets.
  • Develop and execute statistical analysis and reporting deliverables (tables, figures and listings (TFLs)) in a timely and high-quality manner.
  • Provide input in the design and development of case report forms and clinical study databases.
  • Collaborate with cross-functional teams to ensure timely and quality support for analysis and reporting of clinical trials up to regulatory approval, and product launch.
  • Drive and oversee Statistical Programming activities internally and externally (CRO), and act as project manager for statistical programming deliverables.
  • Assess and perform quality control checks/validation of SAS code and output produced by vendors or other Statistical Programmers for SDTM datasets, ADaM datasets, and TFLs.
  • Author and review SDTM and ADaM datasets specifications for datasets programming.
  • Create and review eCTD documents to support regulatory submission package.
  • Provide programming support for building integrated summary of safety/efficacy datasets and analysis.
  • Participate in the development and review of relevant SOPs.

 

Qualifications and Professional Experience:

  • MS in Statistics, Computer Science or a related field with at least 8 years (or BS in Statistics, Computer Science or a related field with at least 10 years) of SAS programming experience in the pharmaceutical or biotech industry.
  • Proven experience of independently leading statistical programming activities for regulatory submissions.
  • Demonstrated ability to manage CRO relationships and oversee programmed deliverables.
  • Experience in providing statistical programming support to early and late phase clinical trials, and regulatory submissions (NDA, MAA).
  • Strong hands-on SAS programming skills.
  • In-depth knowledge of CDISC standards for SDTM and ADaM and FDA electronic data submission requirements.
  • Experience in developing programming specifications, integrated summary safety/efficacy datasets and analysis, electronic submission data package in the eCTD format.
  • Familiar with statistical analysis methods and clinical data management concepts.
  • Deep Knowledge and experience with FDA and GCP/ICH regulations and guidelines.
  • Ability to manage multiple projects simultaneously, to manage conflicting priorities, and to be flexible when priorities change.
  • Excellent written and verbal communication skills along with organizational and documentation skills.
  • Excellent attention to detail and problem-solving skills.
  • Proven project management skills, professional attitude, self-improvement mentality with positive attitude.

 

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.

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