Careers at X4
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
X4 Pharmaceuticals is developing novel therapeutics designed to improve immune cell trafficking including the ability for T-cells to track and destroy cancer cells. Our small molecule drug candidates inhibit C-X-C receptor type 4 (CXCR4), a receptor over-expressed in many cancers. Inhibition of CXCR4 is designed to block non-cancerous immunosuppressive and pro-angiogenic cells from populating the tumor, disrupting the cancer microenvironment and restoring normal immune surveillance functions. We are committed to advancing the field of cancer immunotherapy and immune disorders through innovation and investment in our proprietary clinical and preclinical pipeline.
Reporting to the Vice President of Clinical Operations and Strategy, the Associate Director, Clinical Data Management will be responsible for the clinical data activities that involve existing and new studies. The position will be accountable for ongoing data cleaning, quality, review and vigilance. Additionally, this role is responsible for data management activities at global CROs and lab vendors and will serve as an internal expert in all areas of CDM processes and technology. This position is also responsible for generating ad-hoc data requests for review of data and simple graphical displays of data.
Scope of Work and Responsibilities:
- Lead database development and eCRF design
- Reviews new and ongoing eCRF changes, responds accordingly to make resulting database changes
- Works closely with CROs to prepare and ensure proper execution documents such as CRFs, data management plans, dataset transfer standards, WHODrug and MedDRA coding standards, manual review plans, line listing review plans, and data validation plans
- Plans and implements UAT, data important specifications, data entry guidelines, CRF completion guidelines, and related operational manuals/guidelines
- Core team member, initiates data management planning for all stages of studies, review and sign off on various items such as eCRF, data validation, data review guidelines, and data management plans
- Develops and executes data validation guidelines. Coordinates and participates in the review of clinical data, analysis tables/listings/figures, and patient profiles for data consistency and accuracy
- Accountable and responsible for ensuring data quality and the timeliness of CDM deliverables
- Responsible for the review of coding of trial data and reconciliation of any data relating to adverse events
- Coordinates data live activities
- Responsible for the planning and reconciliation of of medical coding and safety database
- Tracks and reports status of data management project(s)
- Generates and manages clinical trial data queries
- Responds to internal and external requests for data review and presentation
- Ensures data management activities are conducted in accordance with GCP, GCMP, internal SOPs, and meet all regulatory requirements
Qualifications and Professional Skills:
- Minimum of 5+ years data management experience in a CRO, biotech/pharma experience also preferred
- Bachelor’s degree required, Masters a plus
- Global/international experience in clinical data management
- Experience running clinical trials through at least Phase II
- Knowledgeable and through understanding of drug development, study conduct processes, regulations related to and affecting clinical data management including but not limited to GCP. ICH guidelines, EU directives, and other relevant regulations and guidelines
- Develops and implements CDM standards
- Displays strong written and oral communication skills
- Pays attention to detail and can problem solve under strict deadlines
- Ability to work cross functionally and collaboratively with teams to meet timelines and budgets
- Reputation for integrity and acheivment of goals to support the mission and values of the X4 team
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.
We invite you to apply for any of our current openings at email@example.com for additional employment related information.