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: Boston MA, USA

Director/Senior Director, Clinical Business 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, once-daily, oral inhibitor of CXCR4, currently in a Phase 3 clinical trial for the treatment of WHIM syndrome, a rare, inherited, primary immunodeficiency disease caused by genetic mutations in the CXCR4 receptor gene. Mavorixafor has demonstrated proof-of-concept in WHIM syndrome in a Phase 2 trial, including clinically meaningful increases in neutrophil and lymphocyte biomarker counts, as well as a trend of reduction in infection rates and wart burden, and a favorable safety profile. Mavorixafor was recently granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with WHIM syndrome, and was granted orphan drug status by the FDA in 2018 and by the European Commission in 2019 for the treatment of WHIM syndrome.

Mavorixafor 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 Head of Development Operations, the Director/Senior Director, Clinical Business Operations will be responsible for building and leading Clinical Business Operations capabilities to optimize Clinical Operations’ performance, costs and quality. He/She will partner closely with Quality Assurance to ensure Clinical Operations’ GCP compliance, completion of SOPs and audit readiness. The candidate will lead initiatives to improve effectiveness and efficiency within Clinical Operations as well as in outsourcing including RFP and bid defense process. He/She will also assess current capabilities, identify gaps / opportunities to enable the advancement of the pipeline and function as the driver of, and process champion for, new capability builds. In addition, the candidate will have oversight of all SOP and Training, Process and Inspection Readiness, Trial Master File, and the Systems and Metrics teams.

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

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

 

Scope of Work and Accountabilities:

  • Create, define and lead the overall outsourcing strategy, including potential preferred provider relationships, negotiated rates, volume discounts, etc.
  • Partner with the key business stakeholders across the organization to define and execute sourcing strategy to meet X4’s long-term business objectives.
  • Drive company-wide compliance of outsourcing procedures and look to improve processes and policies to drive highly effective and efficient processing and reporting on purchased goods and services.
  • Operationalize category management to deliver value across the organization through cross-functional project execution, operational excellence, supplier relationship management, negotiation of supply agreements, performance measurement and risk management.
  • Collaborate with internal business partners and advocate for strong account and vendor management capabilities within X4 business lines.
  • Map and evaluate X4 vendor landscape to improve vendor performance, gain efficiencies, and reduce risk while identifying opportunities for cost savings and track category spend and ROI
  • Identify, lead and execute operational excellence strategy.
  • Lead the implementation/evolution of Clinical Operations systems, processes and ensure alignment on standard practices across functions or teams.
  • Establish and foster effective executive relationships with key suppliers
  • Identify opportunities to leverage within and across vendors; build strong partnerships to enable streamlined outsourcing approach
  • Support the clinical development team(s) in leading the RFI/RFPs/bid defense process for vendor selection
  • Support root-cause analyses and remediation CAPAs for cross-functional quality and execution challenges in partnership with the Head of Development Operations
  • Assess, support and select/implement tools and technologies to meet Clinical Operations business needs
  • Represent Clinical Operations in cross-functional project workstream(s) to successfully implement new processes and quality improvement activities for operational efficiency
  • Partner with Head of Development Operations in the development of project updates, reports, memos, and presentations, as needed
  • Support Head of Development Operations in management of budget, capacity, resources and preparation of associated analyses and reports
  • Proactively identify risks and issues that could impact the successful execution of business objectives and support the development of appropriate mitigation or corrective action plans for vendor performance or quality issues
  • Support root-cause analyses and remediation CAPAs for cross-functional quality and execution challenges in partnership with the Head of Development Operations
  • Develop milestone timeline dashboards and KPIs
  • Oversee vendor governance activities and coordinate oversight meetings
  • Partner with Clinical Operations, Finance and Legal to create standard vendor budget and SOW templates

 

Qualifications and Professional Experience:

  • Advanced scientific degree with at least 13 years of work experience in the Pharmaceutical/Biotechnology industry
  • Deep knowledge and experience in Clinical Business Operations, Clinical Operations leadership and/or outsourcing oversight and relationship management
  • Expert knowledge of FDA and ICH GCP regulations and guidelines
  • Experience in the clinical drug development process within clinical program planning through final study report
  • Excellent people leader with strong coaching and mentoring skills
  • Track record of strong personal performance combined with demonstrated ability to build and lead high performing teams in a fast growth environment
  • Demonstrated problem-solving and critical thinking skills
  • Demonstrated ability to work effectively in a dynamic, complex and fast-paced team environment

 

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

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

Clinical Trial 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, 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.

Mavorixafor 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 Director, Clinical Operations, Rare Disease, the Clinical Trial Associate is/will be responsible for the conduct of the study and interfaces with the Study Manager and the Study Team. The CTA also supports the Study Team by creating and distributing study team materials, tools and documents. In addition, duties will vary slightly based on whether the study is insourced or outsourced, phase of the study lifecycle (start up, maintenance, close out). The ideal candidate would have some experience with insourced and outsourced studies. He/She will also assist with assigned studies and maintain focus on intended timelines and the achievement of study goals, while ensuring quality in accordance with FDA, EMA, GCP, and ICH guidelines.

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

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

 

Scope of Work and Accountabilities:

  • Creating and/or reviewing study plans, specification documents, materials and tools oversight of outsourced activities to Clinical Research Organizations (CROs) and other third-party vendors for assigned start-up activities.
  • Responsible for tracking study progress in CTMS, including patient enrollment and patient status, and oversight of Regulatory documents for site initiation.
  • Deliver and execute on operational tasks, assist in tracking study metrics, maintain, and distribute study trackers.
  • Collaborate with clinical trial sites to develop relationships and support the collection of relevant study materials and documentation.
  • Review documents for completeness, accuracy, and compliance with protocol and appropriate regulations; Identify issues and take appropriate corrective actions.
  • Assist in the preparation of study related documents (i.e. ICF, clinical trial tools, templates, training materials, manuals, study newsletters, etc.).
  • Support project meeting logistics such as: calendar management, room & equipment set up, collation of materials, and attendance tracking. Working with the CTM, prepare meeting agendas and draft meeting minutes.
  • QC oversight of CRO, TMF, Monitoring Visit Reports, Payments, Safety Alert acknowledgements, ICFs and timelines.
  • Build strong professional relationships with visitors, vendors, and individuals at all cross functional levels of the organization.
  • Process and track payments to vendors and study sites as appropriate.
  • Oversee TMF Quality Review for study team; complete TMF QC for department on a quarterly basis for each study including collecting, reviewing and submitting documents to the TMF.
  • Generate, finalize and distribute study team agendas and meeting minutes.

 

Qualifications and Professional Experience:

  • Bachelor’s degree in life sciences or healthcare related field.
  • 2-5 years’ experience in relevant field, e.g. clinical site, CRO, Sponsor or clinical trial vendor (sponsor experience preferred).
  • Working knowledge of ICH GCP regulations and clinical protocols.
  • Strong knowledge of computer skills including Smartsheets, Excel, Word, PowerPoint, SharePoint, Veeva, and Outlook.
  • Sound analytical and problem-solving skills; ability to act with a sense of urgency.
  • Demonstrated effectiveness in resolving complex site management issues.
  • Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling, and meeting deadlines.
  • Ability to work in a fast-paced environment with demonstrated agility to juggle multiple competing tasks and demands.
  • Excellent written and verbal communication skills.
  • Team player that takes initiative and is willing to support optimizing the way we work.

 

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

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

Senior Executive Assistant

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.

Mavorixafor 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 Chief Medical Officer, the Senior Executive Assistant will be responsible for a full scope of administrative assistance to the Chief Medical Officer and Senior Vice President, Regulatory Affairs. This individual will work on complex and rapidly changing projects involving concentration that require attention to detail, initiative, tact, and must exercise utmost as well as discretion and confidentiality in all assignments. The Senior Executive Assistant must be a leader with proven experience in building collaborative relationships among his/her superiors, peers, and subordinates. The successful candidate is a self- starter and able to understand the business priorities and be able to work reliably with little supervision. He/She will serve as the trusted gate keeper for senior leaders in the organization and will use their outstanding written, verbal, and electronic communication skills as a critical voice of the company on behalf of the Chief Medical Officer and the Senior Vice President, Regulatory Affairs. He/She will use sound judgment and juggle key tasks in a fast-moving environment that will contribute greatly to the mission of the organization. The successful candidate will have a proven record of high achievement of administrative experience, professionalism, reliability, and excellent personal and
organizational skills.

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

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

 

Scope of Work and Accountabilities:

  • Provide executive level support to the Chief Medical Officer and Senior Vice President, Regulatory Affairs.
  • Manage and maintain calendar, requiring interaction with both internal and external executives and assistants, as well as consultants, to coordinate a variety of complex meetings and travel across time zones.
  • Demonstrate proficiency in preparing meeting materials such as Power Point presentations, meeting binders, agendas, minutes, making reservations, planning dietary needs, scheduling travel arrangements, communicating essential information to participants, etc.
  • Arrange and coordinate domestic and international travel, including meeting material preparation and expense reporting.
  • Act as confidential assistant, preserving the confidentiality of information related to the organization and staff.
  • Assist with confidential and/or sensitive matters; provide explanation and support where needed.
  • Prepare talking points for presentations, reports, and narratives.
  • Manage and contribute to the strategic prioritization of tasks, initiatives, projects, and people’s management needs as identified by the Chief Medical Officer and Senior Vice President, Regulatory Affairs.
  • Demonstrate poise and flexibility in a fast paced and dynamic environment. Able to prioritize and manage multiple projects simultaneously and follow through on issues in a timely manner. Goes beyond responsibilities to help the Senior Leaders accomplish tasks and goal.
  • Act as the point of contact and liaison with internal colleagues and proactively anticipates administrative needs of the Chief Medical Officer and Senior Vice President, Regulatory Affairs. Consistently recognizes ways to offer additional support, completing tasks to satisfaction.
  • Positively represent the team and Company to internal and external contacts, including company executives, Board members, potential business partners and vendors.
  • Support or organize advisory boards or other meetings with external stakeholders.

 

Qualifications and Professional Experience:

  • 8+ years’ experience as an Executive Assistant supporting a C-level in a high growth, publicly traded biotech company
  • In-depth knowledge of and experience in the biotech/biopharmaceutical industry or similar
  • Ability to navigate and be successful in a fast-paced, highly matrixed, dynamic work environment
  • Documented history of successful engagement with all levels of the organization and external partners
  • Ability to handle a wide variety of activities with significant attention to detail and use judgement with confidential matters with discretion
  • Demonstrated aptitude to anticipate needs and issues before they arise, proactively identify solutions and work independently
  • Experience with Microsoft Office programs, specifically Outlook, Excel, Word, SharePoint, and PowerPoint
  • Ability to think independently and fully integrate into a high achieving team environment
  • Ability to work in a fast-paced environment with demonstrated agility to juggle multiple competing tasks and demands.
  • Excellent written and verbal communication skills.
  • Team player that takes initiative and is willing to support optimizing the way we work.

 

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

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

Director, Medical Communications and Publications

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 Inborn Errors of Immunity (IEI) and cancer. A number of IEI are attributed to the improper trafficking of immune cells related to the CXCR4 receptor and its ligand CXCL12.

X4 Pharmaceutical’s lead product candidate, mavorixafor (X4P-001), is a potentially first-in-class, once-daily, oral inhibitor of CXCR4, currently in a Phase 3 clinical trial for the treatment of WHIM syndrome, a rare, inherited, primary immunodeficiency disease caused by genetic mutations in the CXCR4 receptor gene. Mavorixafor has demonstrated proof-of-concept in WHIM syndrome in a Phase 2 trial, including clinically meaningful increases in neutrophil and lymphocyte biomarker counts, as well as a trend of reduction in infection rates and wart burden, and a favorable safety profile. Mavorixafor was recently granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with WHIM syndrome and was granted orphan drug status by the FDA in 2018 and by the European Commission in 2019 for the treatment of WHIM syndrome.

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

Reporting to the Vice President, Medical Affairs, Director of Medical Communications and Publications is/will be responsible for providing non-promotional scientific, educational, and research support for X4’s Rare Disease and oncology portfolio. This HQ-based role serves as a clinical expert who strategically supports the medical and scientific objectives of X4’s development and marketed programs. S/he will be responsible for communicating the science and clinical application of X4’s molecules across all therapeutic areas to the medical community and payers. This individual will lead the development and execution of scientific data dissemination strategy for all therapeutic areas within X4. S/he will also be responsible for gathering scientific insights from KOLs to inform strategic planning and improve the positioning of X4 in the therapeutic areas of interest. Overtime, this role will lead and manage a team of medical communication and publication professionals to help bring transformative therapies to patients with unmet medical needs.

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 drive the development of publications, including abstract submissions to medical congresses, posters, and platform presentations.
  • Responsible for the development of medical education initiatives, including live education programs, congress symposia, online education, multichannel HCP education, field medical tools, slide decks, and medical booth resources.
  • Initiate and develop core communication strategic tools such as the scientific platform, narrative, lexicon, FAQs/backgrounders, standard response letters, and advisory board content.
  • Establish and maintain collaborative business partnerships with clinical, medical affairs and program leads to align on medical communications strategy across all X4 programs.
  • Develop and execute a global publication and medical communication plans for the organization related to all programs.
  • Ensure appropriate tracking and execution of the publications tactical and medical communication plan in accordance with established priorities and company key performance indicators.
  • Ensure key data is strategically aligned with scientific communication points, elements from other internal guidance and resource documents are included appropriately in all publications, and that the conclusions are supported by data.
  • Provide medical input to brand teams regarding strategy, tactics, and development of claims.
  • Serve as an internal disease state and product expert for training of medical and commercial colleagues.
  • Engage with KOLs as authors for publications and advisors for medical communication initiatives.
  • Participate in budget forecasting and long-range planning for strategic growth within the department.
  • Attend key international and national medical conferences to support medical affairs activities.
  • Provide input into the planning and execution of advisory boards and MSL roundtables.
  • Lead gap analysis to identify and address medical education and data/evidence gaps.
  • Provide input into clinical and Phase IV/investigator-sponsored studies, including disease and product registries to support integrated evidence generation plan.
  • Accountable for meeting corporate goals and objectives in compliance with applicable policies and regulations.

 

Qualifications and Professional Experience:

  • Advance degree in life sciences or pharmaceutical sciences (PhD, PharmD, or MD) with 8+ years of relevant medical affairs experience.
  • A minimum of 8-10 years pharma/biotech industry global or US experience highly preferred.
  • Rare Disease and/or Oncology experience preferred, but not required.
  • Ability to interpret and critique scientific and medical literature with respect to scientific and business implications.
  • Experience and demonstrated skill in the analysis, communication and presentation of complex scientific and medical data.
  • Knowledge of industry guidelines pertaining to data dissemination (e.g., CONSORT, ICMJE, GPPs) and interactions with health care providers (e.g., PhRMA).
  • Track record of successfully developing peer-reviewed publications is required.
  • Ability to collaborate with external Key Opinion Leaders on data dissemination strategies in a credible, responsive and scientific manner.
  • Excellent interpersonal and communication skills, written and verbal; comfortable and experienced in making presentations.
  • Demonstrated ability to work effectively in a matrix environment.
  •  Creative problem-solver with strong business acumen and skills.
  • Exceptional time management and organizational skills.
  • Require 20-30% travel both domestic and international.
  • Passionate about making a meaningful difference in patient care.

 

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

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

Associate Director/Director of Biostatistics

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.

Mavorixafor 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, Biostatistics the Director/Associate Director of Biostatistics will be responsible for providing leadership and oversee all biostatistics activities for oncology and rare disease areas for clinical program(s) to ensure valid and efficient statistical designs, accurate analyses, and timely delivery of reports and regulatory submissions. She/he will build and maintain a 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.

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

 

Scope of Work and Accountabilities:

  • Oversee statistical support for phase II and phase III studies for oncology and rare disease programs.
  • Collaborate with clinical and regulatory leads in defining strategic approach, creating clinical development plans (CDP), and producing individual protocols.
  • Provide 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 and drive 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.
  • Oversee 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 area

 

Qualifications and Professional Experience:

  • PH.D/MS in Statistics or Biostatistics with a minimum of 7/10 years of Pharmaceutical/Biotechnology industry
  • Deep experience of 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.
  • Deep understanding and 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.


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

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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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