Director, Clinical Operations (Early Phase)

Director, Clinical Operations

Reporting to: Vice President, Clinical Operations

Do you have the passion and commitment to join a group whose mission is to develop treatments that have a clear and profound impact on patients suffering from rare diseases? Does it excite you to be a part of a patient-focused company developing potential new treatments that could dramatically improve the lives of patients with limited to no current treatment options? If yes, we encourage you to share with us your aspirations and career goals.

X4 is focused on restoring healthy immune system function by developing novel therapeutics to treat chronic neutropenic disorders, including rare primary immunodeficiencies. We are advancing a novel, late-stage clinical candidate, mavorixafor, that we believe has the potential to become a new standard of care for patients with these disorders. We know that developing innovative, new medicines is challenging, and we invite new colleagues who share our values and commitment to join us in achieving our mission.

This opportunity will …

• Align with your values and grit, and passion for innovative science.
• Leverage your deep knowledge of Clinical Operations to support our innovative science and allow you to have a major impact on our mission to support our patients.
• Offer a collegial environment with a team-based approach, where our mission drives our values, behaviors, and creativity.
  
  
  

Accountabilities And Responsibilities

The Director, Clinical Operations plays a critical role in overseeing and executing high quality Clinical Pharmacology and early phase studies and programs on time and within budget, including providing Clinical Operations support and expertise to the Research/Translational Medicine team when applicable. This is a collaborative role in a cross-functional and matrixed environment.

• Develop and implement Clinical Operations and study-specific strategies aligned with the clinical development plan.
• Collaborate closely with cross-functional stakeholders and external vendors to manage, oversee, and ensure successful execution of clinical trials.
• Function as the liaison between CROs and establish quality guidelines to ensure CROs are meeting standards.
• Oversee the performance of all activities assigned to CROs and other third-party vendors.
• Monitor study progress, data collection, and data cleaning.
• Prepare study reports and status updates for leadership.
• Responsible for overall management and maintenance of budget, resources, and timelines for studies within remit.
• Proactively identify and manage risks and mitigation plans, issues, and contingency planning.
• Serve as a leader to proactively manage Clinical Operations activities for efficiency, quality, and progress.
• Offer Clinical Operations expertise to study and program-level plans and documents.
• Lead and/or support the development of best practices and functional SOPs.
• Line management, leadership, and/or mentorship of Clinical Operations junior staff.
• Potential opportunities to lead, oversee, manage, and support late-stage studies and programs.
  
  

Requirements: Proven Experience, Skills, and Education:

• Bachelor’s Degree required; Advanced degree preferred.
• 10+ years of experience in Clinical Operations with 8+ years direct experience in management and oversight of Clinical Pharmacology and early phase studies.
• Experience in planning, management, and oversight of early phase clinical trials and programs.
• Experience in rare disease or other complex therapeutic areas.
• Knowledge of regulatory requirements, and experience with NDA and/or BLA submissions as well as FDA regulations and other international regulatory agencies.
• Excellent knowledge of and ability to implement Clinical Operations concepts and operational practices.
• Proven experience with 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 the cross-functional team level.
• Understand the concepts and implementation of budget development.
• Some travel required.
  
  
  

This position is based in Boston, MA, and offers a flexible hybrid work model with a minimum of 2 days/week in the office.

We encourage you to learn more about X4 Pharmaceuticals. Click on the links below!

About Us

Pipeline

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 note that effective January 1, 2022, as a condition of employment at X4 Pharmaceuticals, all employees and new employees must have received their complete doses of the COVID-19 vaccine and one booster unless they have been granted an exemption by X4.