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Miltenyi Biotec Inc

VP CAR-T Operations, US Biomedicine •PC 1504

Miltenyi Biotec Inc, Washington

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Description

Your Role :

The Vice President, CAR T Operations is a senior executive leader responsible for building and executing the integrated operational infrastructure required to successfully launch and scale Miltenyi Biomedicine's first CAR T-cell therapy. This critical role spans the full therapy delivery continuum - from onboarding CAR T treatment centers and ensuring operational launch readiness, to managing product scheduling and order fulfillment, and leading a robust, compliant patient support services function that ensures timely access, navigation, and continuity of care for patients.

As the executive lead for therapy onboarding, this individual will architect and oversee a seamless experience for hospitals, healthcare providers, and patients, rooted in operational simplicity, regulatory alignment, and deep familiarity with the cellular therapy landscape. The leader will own the design and deployment of all onboarding strategies, scheduling and ordering systems, commercial readiness planning, and the 3PL and state licensing frameworks needed to ensure compliant product delivery. Central to this role is the strategic buildout of the patient support ecosystem - including a case management team, third-party service partners, and integrated support infrastructure - that will enable patients to access therapy efficiently while minimizing burden on providers. By orchestrating cross-functional execution across Medical, Market Access, Legal, Quality, Manufacturing, Compliance, and Commercial, this leader will deliver a hospital-centric, patient-first model that accelerates adoption and supports sustained success in the market.

Essential Duties and Responsibilities :

Operational Leadership for Launch Readiness

  • Serve as the executive owner of the therapy onboarding and operations workstream within the broader cross-functional launch plan.
  • Lead strategic planning and execution for therapy access infrastructure, site onboarding operations, scheduling, patient services, and product ordering systems.
  • Collaborate deeply with colleagues across Commercial, Manufacturing, Regulatory, Market Access, and Quality to align timelines, define business requirements, and ensure readiness of all supporting systems and partners.
  • Contribute to launch-critical activities including REMS planning, patient flow mapping, and integration of operational systems into the broader commercialization framework.

Onboarding & Treatment Center Enablement

  • Design and operationalize a streamlined, standardized onboarding model (aligned with the ASTCT 80 / 20 framework) that reflects existing CAR T practices and minimizes burden on sites.
  • Partner closely with the Cell Therapy Account Management team to coordinate center onboarding efforts and ensure a unified customer experience across operational and commercial touchpoints.
  • Lead the cross-functional effort to activate new sites, including site qualification, contracting, training, and operational readiness assessment.
  • Guide the design and execution of apheresis site onboarding and qualification, ensuring GMP-compliant readiness while maintaining clarity around the company's role and responsibilities.
  • Continuously refine the onboarding process post-launch based on stakeholder feedback and system learnings.

    • Scheduling & Product Ordering Infrastructure

  • Own the development and implementation of the enterprise-wide scheduling and product ordering platform, ensuring operational integration with 3PL, Manufacturing, and Patient Services.
  • Design a digital control tower experience that delivers real-time visibility into patient and product flow, enhancing decision-making and service coordination.
  • Ensure the infrastructure supports dynamic scheduling, aligned to manufacturing slots, clinical calendars, and site capacity.

    • Patient Support Services & Case Management

  • Build and lead a best-in-class Patient Support Services organization, including internal case managers and external vendors, to support patients from therapy consideration through treatment completion.
  • Establish a scalable, compliant case management model with core functions in access navigation, benefits verification, logistical coordination, and ongoing patient communication.
  • Ensure integration of patient services into therapy access processes - including scheduling, ordering, reimbursement, and treatment center communication.
  • Lead strategic vendor contracting and oversight (e.g., HUB providers, nurse navigators), ensuring high-quality, cost-effective service delivery aligned with compliance standards.
  • Partner with Market Access, Legal, Compliance, and Regulatory teams to ensure all patient-facing operations meet FDA, OIG, HIPAA, and state / federal legal requirements.
  • Create a patient-centric post-launch optimization strategy, leveraging data and field insights to improve support quality, access timelines, and patient / provider satisfaction.

    • 3PL Management & Fulfillment Strategy

  • Serve as the executive owner of 3PL strategy, vendor selection, contracting, and operational oversight.
  • Ensure seamless, compliant execution of CAR T therapy fulfillment, inventory tracking, order reconciliation, and transaction processing.
  • Integrate 3PL functions into the broader patient support and scheduling infrastructure to ensure a unified, high-reliability customer experience.

    • Licensing & Regulatory Enablement

  • Lead the state licensing strategy and execution to ensure legal commercialization of CAR T therapies across all required jurisdictions.
  • Collaborate with Legal, Distribution, and Compliance teams to manage ongoing license maintenance and expansion post-launch.
  • Ensure robust internal governance and SOPs for regulatory inspection readiness.

    • Requirements :

  • Bachelor's (BA / BS / BSN) degree required. Advanced degree (MBA, MPH, PharmD, PhD) preferred; Minimum of fifteen (15) years of progressive leadership experience in patient access, customer support, or other relevant function within the pharmaceutical industry; or a combination of education and experience.
  • Proven success in launching complex, high-cost therapeutics (cell / gene therapy, oncology, rare disease).
  • Strong experience leading patient access strategy for a high-cost, complex therapy requiring specialized reimbursement and distribution solutions, ideally in oncology, cell therapy, gene therapy, or rare diseases.
  • Executive-level experience leading hospital onboarding, patient support, or therapy distribution
  • Demonstrated ability to navigate regulatory landscapes and lead cross-functional collaboration in a dynamic environment.

    • Knowledge, Skills & Abilities

  • Deep knowledge of U.S. healthcare operations, market access, reimbursement, and patient journey integration.
  • Strategic thinker with hands-on operational leadership skills and a bias for action.
  • Executive presence, with the ability to align and influence across internal and external stakeholders.
  • Demonstrated familiarity with regulatory compliance frameworks : FDA, OIG, HIPAA, REMS, state pharmacy regulations.
  • Data-driven decision-maker with experience implementing scalable systems, performance KPIs, and vendor SLAs.
  • Ability to navigate ambiguity, drive innovation, and execute in a fast-paced, high-growth environment.

    • For internal purposes and to align with our company's job architecture and HR systems, this role is in the first level of the Vice President ladder. This internal title will be reflected in our HR systems, payroll records, and other internal documentation.

    Physical Demands :

    The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch, or crawl. The employee must occasionally lift and / or move up to 50 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

    Work Environment :

    The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a variety of facilities. Each person performing this job must have a home office environment, which is temperature controlled. This job requires the person to be mobile to visit customer sites. Due to the travel requirements, this position may be exposed to natural elements of nature. Used research / clinical equipment may be handled in this job and strict SOPs and PPE must be worn.

    Miltenyi Biomedicine, Inc. is an EO Employer - M / F / Veteran / Disability / Sexual Orientation / Gender Identity

    Miltenyi Biomedicine, Inc. participates in E-Verify.

    Are you ready to start revolutionizing biomedical research? When you join Miltenyi Biotec, you join a family that is passionate about making a real impact - one breakthrough at a time. For over 30 years, we have played a pivotal role in the design, development, manufacture, and integration of products for sample preparation, cell separation, cell analysis, imaging, and cell culture needs. These developments have led to cutting-edge cell and gene therapies - transformative methods that mobilize the body's own cells and genetic blueprint to tackle diseases such as cancer and autoimmune conditions. Today, our more than 18,000 solutions play a vital role in paving the way for the medicine of tomorrow.

    Equal Opportunity Employer

    This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

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