POSITION SUMMARY: 

The Advanced Practice Practitioner, Collection Services provides clinical support to NMDP Medical Directors and protects donor safety, product quality, and regulatory compliance. This role oversees the care of donors participating through NMDP-operated donor and collection centers. Additionally, this role supports quality assurance activities and compliance with FDA regulations, professional standards, and NMDP standards and policies.  This position plays a key role onsite at our Seattle Collection Center.  Our Collection Center has been designed to deliver dedicated donor concierge services, implement an outstanding experience for donors, and create needed capacity as cell and gene therapy industry expands.  #LI-Onsite

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ACCOUNTABILITIES: 

Collection Services:

• Performs complete physical exams of potential donors and distinguishes between normal and abnormal findings.
• Selects and orders lab tests and procedures as specified by NMDP and augment the physical exam findings.
• Reviews and interprets donor medical workup documents to determine donor eligibility and suitability for clearance.
• Supervises the apheresis collection process and oversees the care of donors participating through BTM-operated collection centers.
• Provides clinical support to the medical director and functions in a collaborative role with the nursing staff, site manager, and medical director.

Donor Medical Services:

• Provides clinical support to the Medical Director and other Advanced Practice Practitioners.
• Protects donor safety, product quality, and regulatory compliance.
• Oversees the care of donors participating through NMDP-operated donor and collection centers.
• Reviews and interprets donor medical workup documents to determine donor eligibility and suitability for clearance.
• Provides medical leadership for all aspects of donor management including donor recruitment, health screening, workup, collection, infectious disease counseling, and post-collection follow-up.
• Provides consultation with network physicians and coordinators.

Transplant Medical Services:

• Provides medical leadership and direction for day of collection medical and logistical issues.
• Manages post collection donor recovery, complications, and adverse events.
• Participates in the investigation, management, and reporting of donor and recipient adverse events. ?
• Participates in the investigation, management, and reporting of medically relevant quality incidents, including product complaints.
• Provides consultation with transplant center physicians and coordinators.

Quality and Regulatory Compliance:

• Provides medical input into FDA and HRSA submissions including adverse event reporting and annual reports of NMDP sponsored INDs.
• Ensures regulatory compliance of donor activities.

REQUIRED QUALIFICATIONS:

Knowledge of:

• Medical/scientific knowledge of stem cell transplantation, blood banking, apheresis, and good tissue practices.
• Donor medical care and management, including primary health care.
• FDA Biologics, Drug and Tissue regulations (including GMP/GTP), HIPAA, and other applicable regulatory requirements.
• Demonstrated program management to include ensuring quality assurance standards and strategic and operational planning.

Ability to:

• Provide medical and team functional leadership.
• Provide problem solving and critical decision-making leadership to medical and quality staff, cross-functional teams, and with network physicians and partners.
• Demonstrate leadership through tactful interpersonal skills, demonstrated ability to manage and motivate direct report staff, quality assurance standards, administration and implementation of quality improvement programs.
• Meet deadlines and manage multiple tasks simultaneously.
• Interpret labs, EKGs, and other routine clinical test results.
• Be available during non-core business hours based on donor needs.

Education and/or Experience:

• Licensed Nurse Practitioner or Physician’s Assistant with applicable degrees and 3-5 years’ experience.   

PREFERRED QUALIFICATIONS:

• Post graduate training in Hematology, Oncology, Stem Cell/Bone Marrow Transplantation, Transfusion or Apheresis Medicine, Internal Medicine, or Pathology.
• Previous experience with unrelated stem cell donors and transplantation, blood-banking, or apheresis.
• Demonstrated knowledge of human subjects’ protections and regulations.

Proof of COVID-19 vaccination with acceptable documentation is required for employment. NMDP will consider all requests for medical or religious accommodation.