X4 Pharmaceuticals, Inc.
Director, Clinical Data Management
X4 Pharmaceuticals, Inc. - Boston
Work at X4 Pharmaceuticals, Inc.
Overview
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Overview
Do you have the passion and commitment to join a team whose mission is to develop treatments that have a clear and profound impact on people with rare diseases? Does it excite you to be a part of a company developing potential new treatments that could dramatically improve the lives of people with limited to no treatment options? Named one of the Top Places to Work by The Boston Globe, X4 is an exceptional place, focused on open communication and collaboration and dedicated to each other, our partners, and the medical community.
With the April 2024 U.S. approval of our first drug XOLREMDI (mavorixafor), we have made great progress in advancing our patient-centric mission and in evolving the company into a fully integrated pharmaceutical company. But there is so much left to do! We are continuing to explore global opportunities for mavorixafor in its first indication, while also advancing mavorixafor for people with chronic neutropenia through an ongoing pivotal, global Phase 3 clinical trial. In addition, our research team in Vienna, Austria is focusing on new drug discovery and examining the genetic causes of chronic neutropenic disorders.
We recognize that developing innovative, new medicines is challenging, but we embrace this challenge to truly make progress for patients each day. If you feel you would be a good fit for X4, we invite you to share with us your aspirations and career goals.
At X4 you will find...
A team that values grit and passion of innovative science. The opportunity to leverage your knowledge of Clinical Data Management to support our innovative science and allow you to have a major impact on our mission to support our patients. A collegial environment with a team-based approach, where our mission drives our values, behaviors, and creativity. Your Responsibilities:
Provide direction and supervision to the CDM team, ensuring operational excellence and consistency in clinical trial execution. Develop and implement data management processes, standards, and best practices to ensure high-quality data collection, cleaning, and reporting. Oversee vendor performance management for outsourced data management activities. Collaborate with Clinical Operations, Biometrics, Clinical Development and other functional groups to ensure alignment and efficiency in clinical trial execution. Ensure compliance with regulatory requirements (e.g., FDA, EMA, ICH-GCP), industry guidelines, and company SOPs. Support data integration, database lock, and submission-ready datasets for regulatory filings. Work directly with EDC systems and clinical databases to oversee database design, edit checks, and query management. Participate in hands-on review and resolution of data discrepancies, collaborating closely with the study teams. Develop and manage the CDM budget and resource planning for clinical programs. Represent Clinical Data Management in cross-functional meetings, audits, and regulatory inspections as needed. Oversee and build strong sustainable relationships with multiple global CROs/vendors along with managing the process and coordination of each. Accountable for ensuring all data quality and timeliness of CDM deliverables are met and aligned with the business goals; Coordinate with all functions to drive data cleaning. Review, track, and report status of all data management project(s) to senior leadership. What You Will Bring:
Bachelor's degree required within a scientific discipline, advanced degree a plus. Minimum 10 years of experience within biotech/biopharma and/or CRO organization. Extensive knowledge and experience in clinical data management. Direct experience with different Data Management systems and technologies, Electronic Data Capture systems and CDISC data standards. Extensive knowledge reviewing study planning documents such as Edit Check Specs, UAT scripts, Data Management Plans. Comprehensive understanding of database and dictionary structures (e.g., MedDRA, WHO DRUG). Deep understanding of drug development, study conduct processes, GCP and regulations related clinical data management as well as ICH guidelines, FDA/EU regulations. Demonstrated experience in managing multiple CROs/vendors. This position is based in Boston, MA, and offers a flexible hybrid work model with a minimum of 2 days/week in the office.
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. #J-18808-Ljbffr
With the April 2024 U.S. approval of our first drug XOLREMDI (mavorixafor), we have made great progress in advancing our patient-centric mission and in evolving the company into a fully integrated pharmaceutical company. But there is so much left to do! We are continuing to explore global opportunities for mavorixafor in its first indication, while also advancing mavorixafor for people with chronic neutropenia through an ongoing pivotal, global Phase 3 clinical trial. In addition, our research team in Vienna, Austria is focusing on new drug discovery and examining the genetic causes of chronic neutropenic disorders.
We recognize that developing innovative, new medicines is challenging, but we embrace this challenge to truly make progress for patients each day. If you feel you would be a good fit for X4, we invite you to share with us your aspirations and career goals.
At X4 you will find...
A team that values grit and passion of innovative science. The opportunity to leverage your knowledge of Clinical Data Management to support our innovative science and allow you to have a major impact on our mission to support our patients. A collegial environment with a team-based approach, where our mission drives our values, behaviors, and creativity. Your Responsibilities:
Provide direction and supervision to the CDM team, ensuring operational excellence and consistency in clinical trial execution. Develop and implement data management processes, standards, and best practices to ensure high-quality data collection, cleaning, and reporting. Oversee vendor performance management for outsourced data management activities. Collaborate with Clinical Operations, Biometrics, Clinical Development and other functional groups to ensure alignment and efficiency in clinical trial execution. Ensure compliance with regulatory requirements (e.g., FDA, EMA, ICH-GCP), industry guidelines, and company SOPs. Support data integration, database lock, and submission-ready datasets for regulatory filings. Work directly with EDC systems and clinical databases to oversee database design, edit checks, and query management. Participate in hands-on review and resolution of data discrepancies, collaborating closely with the study teams. Develop and manage the CDM budget and resource planning for clinical programs. Represent Clinical Data Management in cross-functional meetings, audits, and regulatory inspections as needed. Oversee and build strong sustainable relationships with multiple global CROs/vendors along with managing the process and coordination of each. Accountable for ensuring all data quality and timeliness of CDM deliverables are met and aligned with the business goals; Coordinate with all functions to drive data cleaning. Review, track, and report status of all data management project(s) to senior leadership. What You Will Bring:
Bachelor's degree required within a scientific discipline, advanced degree a plus. Minimum 10 years of experience within biotech/biopharma and/or CRO organization. Extensive knowledge and experience in clinical data management. Direct experience with different Data Management systems and technologies, Electronic Data Capture systems and CDISC data standards. Extensive knowledge reviewing study planning documents such as Edit Check Specs, UAT scripts, Data Management Plans. Comprehensive understanding of database and dictionary structures (e.g., MedDRA, WHO DRUG). Deep understanding of drug development, study conduct processes, GCP and regulations related clinical data management as well as ICH guidelines, FDA/EU regulations. Demonstrated experience in managing multiple CROs/vendors. This position is based in Boston, MA, and offers a flexible hybrid work model with a minimum of 2 days/week in the office.
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. #J-18808-Ljbffr