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 Senior Vice President, Regulatory Affairs, 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.

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:

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, 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.

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:

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.

Director of Operations and Facilities

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, Finance, the Director of Operations and Facilities will be a major contributor to strategic decision making and be accountable for day to day operations of the entire international organization. He/she will be required to streamline operations in vendor management, facilities and systems and work cross functionally with other global functions and teams. We are seeking a strong leader with demonstrated success driving behaviors that support the company mission.
The ideal candidate will have extensive experience leading, scaling, and maturing a company with global operations during periods of growth. This role requires a depth of experience and leadership in change management, vendor management, project management, facilities, systems and information technology. He/she will be a driving force to set the team up for success and support the company during growth and drive operational efficiencies that improve experiences with internal and external stakeholders.

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:

  • Provide strategic sourcing strategies, operational planning and execution to align with company goals
  • Build and develop strong relationships with external vendors and service providers while overseeing all contract negotiations
  • Develop and implement planning and execution of procurement and systems to enhance processes and procedures
  • Drive and lead various enhancements with internal and external stakeholders to expand the X4 experience
  • Accountable for managing office services by ensuring office operations and procedures are organized, well documented, and understood by all stakeholders
  • Actively participate in the planning and execution of company projects that align with strategic goals
  • Support and coordinate office staff activities to ensure maximum efficiency and employee experience
  • Accountable and responsible for the daily tasks required in all vendor management activities
  • Develop and track budgets for facility operations and information technology to ensure projects and deliverables are met within budget
  • Develop operational strategies and processes that align with and support the global organization

 

Qualifications and Professional Experience:

  • Bachelor’s degree and 7+ years of management experience in a fast-paced organization within Biotech/Biopharmaceutical preferred
  • Flexibility and desire to work in a fast-paced, dynamic environment
  • Deep knowledge of vendor management, informational systems, financial accountability, facilities, events and general operations.
  • Experienced problem solver with the ability to collaborate in a team environment and the ability to work independently with minimal supervision.
  • Deep expertise in office operations, technology and systems.
  • Proven ability and experience to plan, execute and deliver projects on time and within budget
  • Experience with planning and proactively organizing schedules, meetings, and events
  • Proven expertise and reputation for attention to detail and exceptional organizational skills
  • Deep understanding of exercising discretion when handling confidential material and information
  • Ability to work cross functionally within an organization by collaborating and supporting multiple functions, preferably in a global organization
  • Proven experience managing multiple activities simultaneously and prioritize effectively
  • Strong verbal and written communication and interpersonal skills

 

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, 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.

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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