Note: The job is a remote job and is open to candidates in USA. Allogene Therapeutics is a clinical-stage biotechnology company developing allogeneic CAR T cell therapies for cancer and autoimmune disease. The Patient Operations Management Associate will support scheduling, coordination, tracking, and logistics for investigational products and patient enrollment across clinical trials. The role will collaborate with clinical operations, sites, vendors, and other stakeholders to support trial launches, enrollment, supply chain activities, training, and process improvements.
Responsibilities
- Manage patient scheduling tools, guidelines, work instructions, and dashboards for cell therapy product delivery
- Support tracking and reporting investigational product logistics information and patient metrics utilizing databases, spreadsheets, and other tools
- Support communication plans and templates for regular updates with Clinical Operations and sites on patient status
- Support tracking and reporting investigational product logistics information and patient metrics utilizing databases, spreadsheets, and other tools
- Train to handling manuals and training materials for clinical sites regarding patient material shipping and product receipt to CRO staff, clinical site staff, and other audiences as needed
- Support IP logistics and supply chain processes for domestic and international clinical trial activities
- Support the management of vendors and systems associated with IP logistics with cross-functional stakeholder(s)
- Participate in meetings to support the launch of clinical trials and ongoing enrollment activities
- Collaborate with key stakeholders to ensure a thorough patient journey program
- Recommend process improvements and promote a culture of collaboration and execution excellence
- Provides training to CRO staff, clinical site staff, and other audiences as needed
- Participate in the development, review and implementation of SOPs and processes, as needed
- Other duties as assigned
Skills
- Bachelor's degree or relevant experience
- Understand basic FDA & EMA regulations, ICH guidelines, GCP, and GMP
- Experience with clinical logistics and pharmaceutical supply chain systems
- Experience managing logistics activities for outsourced drugs such as warehousing, transportation, customs clearance and invoicing
- Familiar with domestic and international logistics/transport of biologic material: IATA, ICAO, ADR, DOT, WHO
- Excellent interpersonal and collaboration skills
- Able to work independently and collaboratively to accomplish primary objectives
- Demonstrates strong analytical skills to develop solutions to a variety of complex problems
- Organizational skills with the ability to multi-task and prioritize planning of activities
- Can support or lead vendor management efforts, as needed
- Self-starter, possessing a strong work ethic, ability to drive change, and passion for helping others
- Candidates must be authorized to work in the U.S
- Preferred experience in healthcare industry and FDA regulated environment
- East Coast-based candidates are preferred
- Willingness to eventually support EU operations
Benefits
- Remote work arrangement in South San Francisco, CA
- Collaborative work environment
Company Overview