ASSOCIATE MEDICAL DIRECTOR

ADVANCE YOUR CAREER WHILE SAVING LIVES

Location: Oklahoma City, OK

Salary: Competitive pay based on education and/or experience and $500 bonus after 6 months and $1,000 bonus after 1 year!

Benefits: Health, dental, vision, life insurance, long term disability, 401(k), paid-time off, $5,000 annual tuition reimbursement, holiday pay, etc.

Days: Monday through Friday

Hours: 8:00 a.m. to 5:00 p.m.

Position:

The Associate Medical Director is a licensed physician with shared responsibility for the medical, technical and clinical leadership and direction of company operations As a Medical Official, the Associate Medical Director will work with the Chief Medical Officer and other Medical Directors to direct and supervise key staff with the obligation to ensure that the quality of all products manufactured is in compliance with all regulatory requirements. In conjunction with the Chief Medical Officer and other Medical Directors, the Associate Medical Director exercises control over the Institute's operations with regard to all matters relating to compliance, including authority to represent the Institute in all pertinent matters with the Food and Drug Administration (FDA, Center for Biologics Evaluation and Research (CBER)), and the local FDA office.

The Associate Medical Director shares responsibility with the Chief Medical Officer for developing, evaluating and implementing the clinical and medical direction for the Blood Institute and carrying out the critical missions of the organization which include (1) the adequacy, quality and safety of all blood products, (2) medically directing the specialized functions of the Blood Institute which include but are not limited to the reference laboratories, therapeutic apheresis programs, cell therapy product collection and processing, and appropriate medical consultation for patient problems related to transfusion medicine practices, (3) education of the lay community, health care professionals, and other special groups as to the importance of blood donation, appropriate transfusion medicine practices, and the risks and benefits of transfusions to save or improve the quality of life and (4) directing and overseeing appropriate clinical or applications based research intended to improve the quality and/or safety of the blood supply. The Associate Medical Director as requested will assist in the development and implementation of preventive based health programs that can have a positive effect on the health of selected groups as well as the general population in Oklahoma or communities served.

The Associate Medical Director will become sufficiently experienced to cover general medical issues relating to Blood Institute activities and develop expertise in selected medical areas. FACT Facility Medical Director shall have postgraduate training and two years practical experience in product collection, preparation and clinical use of cell therapy products.

In conjunction with the CEO and the Chief Medical Officer, the Associate Medical Director has the responsibility for developing and maintaining the image of the Blood Institute as a medically credible organization primarily serving Oklahoma donors and patients. The Associate Medical Director should have a national or international presence as a leader in transfusion medicine.

Qualifications:

• Doctor of Medicine or Doctor of Osteopathic Medicine
• Training in Pathology or other suitable specialty, with Transfusion Medicine Fellowship training
• Prior Experience as a Medical Director of a Regional Blood Center or hospital blood bank desirable

Primary Responsibilities:

• Responsible for oversight of medical, clinical and technical aspects of OBI operations including pre-collection evaluation of the donors at the time of donation and care of complications resulting from the collection procedure
• Cell Therapy administrative operations including staff supervision, equipment, assay and protocol selection, review and approval of processing records and authorization for release of products including exceptional release for urgent Medical need
• Review and approval of Standard Operating Procedures involving medical, technical and clinical processes
• Compliance with the Cell Therapy Quality Management Program. Review of quality activities with key personnel and report the program's effectiveness to OBI Executive Management and the Clinical Program annually
• Review all clinically relevant adverse events
• Compliance with applicable cell therapy laws, regulations and standards
• Review and approval of all cell therapy validation studies, labels, microbial culture results and data analysis
• Serves as director for laboratories and is responsible to ensure compliance with all aspects of CLIA
• Ensures that the firm's laboratories enroll in an successfully participates in proficiency testing programs
• Approves special services and/or procedures not addressed by and/or that deviate from approved SOPs
• Performs (on call) functions to determine the eligibility of donors and medical consultation for medical facilities in the area
• Provides consultation services to the community physicians as the need arises for clinical transfusion medicine
• Provides medical oversight of therapeutic apheresis and PBPC services
• Provides medical oversight of OBI reference laboratories and transfusion services
• Provides preliminary evaluations of reported events
• Reviews and evaluates proficiencies