Senior Clinical Research Scientist

Senior Clinical Research Scientist
Reporting to: Senior Medical Director, Clinical Development

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 in 2023 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.

This opportunity will ...

• Align with your values and grit, and passion for innovative science.
• Leverage your deep knowledge of Clinical Research 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 Clinical Research Scientist contributes to the creation, design, planning, and execution of clinical development strategy and research projects. The Clinical Research Scientist works extensively with the Senior Medical Director and Medical Director, Clinical Development while collaborating with the Data Management, Safety & Pharmacovigilance, Biometrics, Medical Affairs, Regulatory, and Clinical Operations teams on activities within the WHIM syndrome and Chronic Neutropenia programs.

Th role is responsible for clinical trial design, clinical data analysis, internal and external communication of project information and plans, and contributions to regulatory submissions, publications, and presentations. The successful candidate is capable of prioritizing and overseeing multiple clinical trials/studies, leading them from planning through the full cycle (concept to reports and manuscripts). The position may include assisting the Senior Medical Director with external interactions, including those with health authorities.

• Contribute to the design of clinical studies in close collaboration with the Senior Medical Director, as well as the Clinical Development team.
• Communicate with external medical/scientific advisors, thought leaders, and clinical investigators in the therapeutic areas, as well as with internal management and drug development teams, to prepare/revise/maintain and efficiently execute the drug development plan.
• Support the Senior Medical Director with safety reviews, site interactions and review of Tables, Figures, and Listings (TFLs). Responsible for analytical support of clinical trial data (safety and efficacy), including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations to the Senior Medical Director. Analyze and synthesize information to assess issues relating to protocol conduct and/or individual patient safety. Assist in communicating a clear overview of trial results.
• In collaboration with the Study Team, review protocol deviations (PDs) to identify cause and propose appropriate resolution. Review PD trends and take appropriate actions, as needed.
• In collaboration with Clinical Operations and Data Management, monitor completeness, consistency, and accuracy of data entry in the course of the clinical study.
• Interact with internal and external stakeholders (study sites, vendors, committees, etc.) in support of clinical trial objectives; respond to or triage questions for appropriate escalations.
• Support authoring and review of protocols, clinical study reports, Investigator Brochures (IBs), Informed Consent Forms (ICFs), training documents, charters, and other clinical and regulatory documents under the direction of the Senior Medical Director.
• Collaborate with Translational Science team and provide input on Translational study design, data analysis and conclusions.
• Proactively provide insight on emerging clinical/competitive trends, understanding competitive landscape and providing insights on strategic development pathways. Participate in open-source competitive intelligence and/or other market/industry assessment activities and projects.
• Participate in the identification of appropriate external parties such as investigators and consultants.
• Develop and cultivate relationships with external partners such as clinical investigators, clinicians, and scientists.
• Review, summarize and prepare literature reviews, as needed.
• Support accurate preparation of scientific material for conference presentations or publications.
• Provide support to advisory boards, consultant meetings, and investigator meetings, including preparation and delivery of presentations.
• Proactively recommend and implement process improvements.
• Anticipate potential study problems and prepare contingency plans as needed.
• On occasion, absorb responsibilities outside the scope of core responsibilities.

Requirements: Proven Experience, Skills, and Education:

• RN, MS, PhD or PharmD, with experience in clinical research and drug development (equivalent strongly preferred).
• 5+ years of experience in all phases of clinical trial planning, start up, conduct, reporting and publishing required in the Biotech/Biopharma industry.
• Extensive knowledge of the clinical development process is required and an ability to understand various phases and principles of study design.
• Experience in protocol development, study report preparation and authoring, IB preparation and authoring, and regulatory submissions.
• Working knowledge and thorough understanding of all relevant regulatory guidelines and standards (e.g., GCP, ICH, and FDA guidance documents), as well as practices and expectations of Quality within GCP.
• Successful history interacting with medical monitors, development operations, and clinical investigators.
• Highly analytical with innovative problem-solving, organization, and critical thinking skills.
• Demonstrated interest and experience working with details and the ability to manage and prioritize multiple tasks, especially under tight timelines.
• Ability to work individually, within a multi-disciplinary team, and with external partners.
• Excellent written, electronic, and verbal communication skills and an ability to effectively communicate with diverse audiences.
• Exceptional verbal and electronic presentation skills.
• Ability to assimilate technical and scientific information quickly and proficient in Microsoft Office (Word, Excel, PowerPoint).
• Proficiency in various clinical trial managements systems (CTMS) and databases.
• Reputation for integrity, respect, and teamwork.

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

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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.

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