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.
Mavorixador 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, Clinical Operations, the Senior Director, Pharmacovigilance Operations will be responsible for creating, directing and managing the company’s infrastructure to support the operational aspects of the pharmacovigilance system and adheres to all global safety requirements and internal processes and procedures. He/She will have experience in and perform multiple activities related to X4 case management, data review and assessment, document development and review including procedures for the accurate and timely processing, review and reporting across the portfolio. In addition, this position will build and maintain sustained and trusting relationships with key strategic internal and external stakeholders, including leadership for interactions with health authorities, support review and development of regulatory submissions and PV activities.
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 Cambridge, MA and does not include a relocation package. Qualified out-of-state applicants are responsible for their relocation.
Scope of Work and Accountabilities:
- Drive and lead the building, developing and managing of external resources allocated to operational PV activities (i.e. Safety Vendor, CROs), creating a highly efficient, team to include insourced and outsourced resources, as needed.
- Contribute to the development of global Medical Safety/Pharmacovigilance strategies.
- Responsible for supporting regulatory submission activities related to safety (i.e. Overview and Summary of Clinical Safety).
- Build, implement and ensure regulatory compliance with domestic and international pharmacovigilance systems, regulations, and industry standards.
- Identify, Select and build strong relationships with PV vendors to support the current outsourced PV business model. Provide vendor oversight and management for all PV activities, including establishing and monitoring key quality and compliance metrics.
- Establish a system for prevention and timely correction of deviation to compliance with stakeholders, in collaboration with the PV Quality, Compliance and Safety Systems group and QA team. Support development of functional area SOPs/WIs/Company Safety Governance Policy.
- Oversee the set-up of new safety projects, including development of study-specific Safety Management Plans and set up of safety systems and database configurations in the PV database to accommodate these trials and products.
- Develop and maintain a set of SOPs related to the processing and reporting of SAEs from clinical trials and marketed products, when relevant to ensure performant and compliant PV processing, integrated with other PV and non- PV SOPs.
- Contribute to the signal detection, benefit-risk profile assessment and aggregate reporting activities as requested.
- Responsible for compliant and quality execution of all operational activities related to case management and related activities. Oversee timely submissions of expedited and periodic safety reports to the FDA & other health authorities. Lead authorship and cross functional review of developmental safety update reports (DSURs).
- Identifies deviations and applicable corrective and preventive actions immediately to maintain the compliance reporting at its highest level.
- Develop and implement an inspection readiness program with the contribution of other PV and non-PV stakeholders.
- Ensure that the PV Database supports the department needs, including specific workflows and reporting/querying functionalities. Provide oversight of systems and MedDRA updates in
collaboration with the relevant PV Vendor.
Qualifications and Professional Experience:
- Bachelor’s degree in life sciences, pharmacy, nursing or equivalent health experience; advanced Life Sciences Degree or MBA preferred.
- Minimum of 8 – 10 years of experience in Drug Safety / Pharmacovigilance role in the biotech or pharmaceutical industry.
- Demonstrated ability to create, evaluate and maintain effective business processes, implement procedures, systems and tools to maximize budget and resources within a Drug Safety department.
- Thorough knowledge and experience in all aspects of global safety reporting for clinical trials through commercialization.
- Proven experience with currently available drug safety database systems, document management systems and QC tools. This also includes MedDRA and linked technologies.
- Operational expertise with safety databases such as ARGUS is preferred.
- Deep knowledge in supporting regulatory agency meetings and/or inspections is a plus
- Strong interpersonal, collaboration and leadership skills and demonstrated ability to motivate
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.
Job Type: Full-time
Pay: $0.00 per year
- Pharmacovigilance: 8 years (Required)
- Drug Safety: 8 years (Required)
- Biotech: 8 years (Required)
- Health insurance
- Dental insurance
- Vision insurance
- Retirement plan
- Paid time off
This Company Describes Its Culture as:
- Detail-oriented -- quality and precision-focused
- Innovative -- innovative and risk-taking
- Outcome-oriented -- results-focused with strong performance culture
- Stable -- traditional, stable, strong processes
- People-oriented -- supportive and fairness-focused
- Team-oriented -- cooperative and collaborative
- Temporarily due to COVID-19