Associate Director – ATC Cell Therapy Operations
Iovance Biotherapeutics, Inc.
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $185,000 - $210,000 per year
Job Level
Senior
About the role
- Develop and maintain relationships with key stakeholders from the treatment center responsible for establishing the lifileucel service line (MD, PA, RN, MLT, CQA, etc.)
- Responsible for the operational oversight of treatment centers in the assigned region.
- Lead operational meetings with the physician leadership from Medical Oncology, Surgery, and Cell Therapy to establish a standard of care pathway for LIFILEUCEL
- Lead cross-functional meetings with the nursing, laboratory, pharmacists, quality, and operational champions to develop the product and patient workflows for LIFILEUCEL
- Clinical SME 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 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 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.
- Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
- Perform miscellaneous duties as assigned.
Requirements
- 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.
- 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
operational oversightclinical SMESOP developmenttraining executionlogistics managementquality records managementrisk-based toolsneeds assessmentdecision makingcollaboration
Soft skills
communicationplanningorganizationimplementationpresentation skillsability to perform under pressurematrix organization collaborationprioritizationfacilitationfollow-up
Certifications
BMTCNCPHQPM