Overview
The Director, ATC Cell Therapy Operations Europe responsibilities will include direct contribution, building, and leading the European ATC Cell Therapy Operations team and potentially other countries, as identified. In support of the launch of commercial lifileucel (autologous T-Cell immunotherapy) in Europe, this role will provide operational and quality expertise on establishing lifileucel as a standard of care to physicians, cellular therapy teams, and other health professionals. A key function of this role is to lead the authorization activities of commercial centers and provide operational and quality oversite post-launch. The Director will also help to build and manage the ATC Cell Therapy Operations team for Europe. As a key member of the ATC Cell Therapy Operations (ATC Ops) EX-US leadership team, this role will work cross-functionally with the EX-US team to lead the ATC Cell Therapy Operations work in Europe.
Essential Functions and Responsibilities
- Lead the ATC Cell Therapy Operations work and team in Europe
- Assess resources and create business plans for additional resources
- Work cross-functionally with the Iovance EX-US team for Europe and provide operational and quality expertise as it relates to the operationalization of lifileucel
- Subject matter expert on JACIE, tissue, and cellular therapy regulations in Europe, and other regulatory standards as relevant
- Lead operational meetings with the physician, treatment center leadership, and front-line staff from Medical Oncology, Surgery, and Cell Therapy to establish a standard of care pathway for autologous T-Cell immunotherapy implementation
- Develop key performance indicators and meet established timelines for authorization of treatment centers
- Develop and maintain relationships with key stakeholders from the treatment center responsible for establishing the commercial lifileucel service line (physicians, nurses, cell therapy lab personnel, quality team etc.).
- Responsible for the operational oversight of assigned treatment centers.
- Lead cross-functional meetings with the nursing, laboratory, pharmacists, quality, and operational champions to develop the product and patient workflows for TIL
- Clinical subject matter expert to develop or review operating Procedures (SOPs) required for Treatment Centers to order lifileucel.
- Develop and prioritize solutions to problems post-launch, understand the relationship between actions and results, and be able to understand and appreciate the needs of the authorized treatment centers
- Operational and Clinical Oversight of the tumor collection, final product receipt, storage and distribution, and TIL infusion system.
- Assess and approve any changes to the collection, courier tracking, order intake, and order processing systems to ensure the validated state of the systems is maintained.
- Lead the lifileucel center qualification process using risk-based tools for qualification, training, monitoring, and disqualification.
- Develop and execute training of authorized users. Ensure access to COI/COC is provided to trained individuals.
- Oversee the Chain of Identity and Chain of Custody at the Treatment Center.
- Lead the training distribution to the assigned region.
- Contribute to training content development, review, and creation of education materials.
- Oversee logistics and manage changes for the regional accounts.
- Respond to every detour from the established lifileucel standard of care pathway and commit to responding with the utmost experience and collegiality
- Support and/or own quality records (Deviations, CAPA, Change control, etc.)
- Participate in advisory board meetings to gain insight into future educational needs
- Understands foundational, ongoing and training needs across the ATC Operations Team and Health Care Providers at large academic institutions and develops & executes the training plan and materials.
- Develops exceptional clinical and operational knowledge to execute and facilitate the Authorized User Training program creating and enhancing current training modules using virtual adult learning principles
- Identifies knowledge gaps for the ATC Operations Team develops creative and innovative solutions working independently and through collaboration with appropriate teams
- Creates exceptional training material to engage Authorized Treatment Center personnel and meets all regulatory and quality requirements
- Manages updates to key standard operating procedures (SOPs) for authorized treatment center personnel as well as the ATC Ops team.
- Serves as the subject matter expert in the Learning Management System including maintenance, troubleshooting, dashboards, and reports.
- Deploys and manages training completion for authorized treatment center personnel
- Enhances and creates departmental and treatment center performance dashboards, key performance indicators, and reports for department and leadership.
- Partner with ATC Ops team to streamline workstreams and standard operating procedures related to all aspects of treatment center qualification and post-launch monitoring.
- Manages data and enhances current process for ATC Ops within the current IT system, including Salesforce.
- Partners with Quality, legal, and HR to manage training records within Master Control and Training systems
- Develops and refines external customer-facing training content for customer LMS system
- Develops new hire and on-going training and educational materials for the ATC Operations department.
- Ensures compliance with corporate policies and procedures as well as with US/global healthcare laws and regulations.
- Potential to manage ATC Cell Therapy Operational role to support treatment center in local area
- Provide back-up travel and meeting support to ATC Operations Regional Liaisons, as needed.
- Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
- Perform miscellaneous duties as assigned.
Travel
- Ability to travel up to 50% of the time
Required Education, Skills, and Knowledge
- BA or BS degree is required
- Advanced degree (master’s degree, NP, MHA, MPA, MBA) Certifications preferred (BMTCN, CPHQ, Project Management)
- Must be fluent in English with French and German preferred
- 12+ years of progressive experience in a medical or pharmaceutical environment, including nursing, surgical oncology, and cellular therapy, blood and marrow transplantation, Oncologic infusion centers preferred.
- 5+ progressive experience in leadership and managing teams
- Competence in the following areas: Needs Assessment, Facilitation, Prioritization, Decision Making, Collaboration, Planning & Organizing, Implementation/Follow-up, Written and Verbal Communication
- Demonstrated ability to present compelling and influential oral presentations.
- Management skills and operational capabilities
- Ability to perform under pressure and meet deadlines.
- Ability to work effectively within a matrix organization to achieve desired outcomes.
- Strong organization and prioritization skills with the ability to work independently to achieve high-quality results
- Excellent customer service skills with the ability to quickly troubleshoot and achieve resolution with the client as well as ability to present and facilitate large cross functional meeting both internal and external
- Proficient with Microsoft Office Suite, Word, Excel, PowerPoint etc.
- Demonstrates professional maturity and flexibility.
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.
Physical Demands and Activities Required
- Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
- Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
- Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
- This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
- Must be able to communicate with others to exchange information.
Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines
Work Environment
This job operates in a professional workplace or remote office environment and requires standard office equipment and keyboards. Employees who work remotely are expected to maintain their workspace and environment safely and free from safety hazards.
The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.
Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com.
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