Iovance Biotherapeutics, Inc.
Associate Director, ATC Cell Therapy Operations - West Region
Iovance Biotherapeutics, Inc., San Carlos, California, United States, 94071
Associate Director, ATC Cell Therapy Operations - West Region
Base pay range: $185,000.00/yr – $210,000.00/yr
The Associate Director, ATC Cell Therapy Operations will provide operational and clinical information on establishing lifileucel as the standard of care to physicians and other healthcare providers. The Associate Director will lead the authorization activities of commercial centers and provide operational, quality, and clinical oversight post-launch. The Associate Director 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 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 (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 deviation 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.
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.
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.
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.
Ability to travel 40 %.
Mental Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem‑solving, analysis, and discretion; ability to handle work‑related stress; ability to manage multiple priorities simultaneously; and ability to meet deadlines.
This job operates in a professional or remote office environment and requires operating standard office equipment and keyboards.
#LI-remote
We reasonably expect to pay an annual base salary in the range stated above. Individual pay decisions depend on various factors including primary work location, complexity and responsibility of the role, job duties/requirements, and relevant education, experience and skills.
Pay Transparency $185,000 - $210,000 USD
Seniority level Director
Employment type Full‑time
Job function Other and Science
Industries Biotechnology Research and Pharmaceutical Manufacturing
#J-18808-Ljbffr
The Associate Director, ATC Cell Therapy Operations will provide operational and clinical information on establishing lifileucel as the standard of care to physicians and other healthcare providers. The Associate Director will lead the authorization activities of commercial centers and provide operational, quality, and clinical oversight post-launch. The Associate Director 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 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 (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 deviation 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.
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.
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.
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.
Ability to travel 40 %.
Mental Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem‑solving, analysis, and discretion; ability to handle work‑related stress; ability to manage multiple priorities simultaneously; and ability to meet deadlines.
This job operates in a professional or remote office environment and requires operating standard office equipment and keyboards.
#LI-remote
We reasonably expect to pay an annual base salary in the range stated above. Individual pay decisions depend on various factors including primary work location, complexity and responsibility of the role, job duties/requirements, and relevant education, experience and skills.
Pay Transparency $185,000 - $210,000 USD
Seniority level Director
Employment type Full‑time
Job function Other and Science
Industries Biotechnology Research and Pharmaceutical Manufacturing
#J-18808-Ljbffr