Job Description

The Advanced Practice Practitioner, Medical 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.

ACCOUNTABILITIES:
Donor Medical Services:
• Provides clinical support to the Medical Director.
• 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, HRSA and WMDA 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 including regular on-call rotation.

Education and/or Experience:
• Licensed Nurse Practitioner or Physician Assistant with a Master’s degree or higher from an accredited program with postgraduate training or specialized clinical experience in Hematology, Oncology, Stem Cell/Bone Marrow Transplantation, Transfusion or Apheresis Medicine.
• Minimum of three years of experience in allogenic stem cell transplantation, blood banking, or apheresis.

PREFERRED QUALIFICATIONS: (Additional qualifications that may make a person even more effective in the role, but are not required for consideration)
• Previous experience with unrelated stem cell donors and apheresis management.
• Demonstrated knowledge of human subjects, protections, and regulations.