Overview
The Associate Director, ATC Cell Therapy Operations Europe will provide operational and clinical information on establishing autologous T-Cell Immunotherapy (lifileucel) as the standard of care to physicians and other healthcare providers. The Associate Director, ATC Cell Therapy Operations Europe will lead the authorization activities of commercial centers and provide operational, quality, and clinical oversite post-launch. The Associate Director, ATC Cell Therapy Operations Europe will also identify and develop relationships with Treatment Center’s physicians, nursing, lab, pharmacy, and quality personnel. The successful candidate will have experience working in the cellular therapy field at a treatment center by running operations, the cell lab, or nursing and bringing practical knowledge and skills as they interact with external teams (physicians, surgeons, nurses, administrators, quality personnel) and work collaboratively with cross-functional internal teams. Understanding the environment and influences impacting the treatment centers’ providers and personnel.
Essential Functions and Responsibilities
- Develop and maintain relationships with key stakeholders from the treatment center responsible for establishing the lifileucel service line (physicians, hospital leadership, cell therapy lab personnel etc.
- Responsible for the operational oversight of treatment centers in the assigned region/countries.
- Lead operational meetings with the physician leadership from Medical Oncology, Surgery, and Cell Therapy to establish a standard of care pathway for TIL
- 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 upon approval
- 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 lifileucel 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 treatment center qualification process using risk-based tools for qualification, training, monitoring, and disqualification.
- Develop and execute training of authorized users. Ensure access to Chain of identity/Chain of custody 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 manages 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.)
- Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
- Perform miscellaneous duties as assigned.
Travel
Required Education, Skills, and Knowledge
- Advanced degree (master’s degree, NP, MHA, MPA, MBA) Certifications preferred (BMTCN, CPHQ, PM)
- 10+ years of progressive experience in a medical or pharmaceutical environment, including nursing, surgical oncology, and transplant/infusion centers preferred.
- Must be fluent in English with French and German preferred
- 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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