The Executive Medical Director/ Chief Operating Officer will work as part of a multidisciplinary team to provide medical and technical expertise in the operation of the Apheresis Center.
Responsibilities
- Oversee the day–to–day activities and operations of the Apheresis Center in accordance with professional and OUR standards of practice.
- Oversee the acquisition of AABB accreditation, and then oversee operations to ensure compliance with those standards.
- Develop and support new clinical and research protocols related to cellular therapies by understanding customer needs, determining product specifications, and then delivering products to customers that meet or exceed their expectations.
- Provide guidance to medical staff performing routine donor medical evaluations, obtaining and interpreting laboratory test results, reviewing proficiency, quality control, validation studies, review of apheresis center records, documenting deviations, and reporting occurrences.
- Provides consultation for health history questions, donor counseling, supervision of the administration of the mobilizing agent, supervision of the collection procedure, and follow–up of pre–intra and post–donation donor complications as needed
- Protect the health and safety of donor(s) and the safety of the product(s).
- Identify and implement performance improvement opportunities related to cellular therapy tasks.
- Participate in Senior Management group, providing insight and vision in the field of cellular therapy; and the threats and opportunities for us in this area.
- Plans, organizes, implements, and helps controls Apheresis Center activities and operations; monitors operations to ensure standards and objectives are being met.
- Develops and helps implements limited or short–term plans to keep operations moving smoothly.
Knowledge, Skills and Experience
Expertise and experience in provision of donor medical issues related to eligibility, suitability Expertise in evaluating and correctly addressing pre–procedure, intra procedure, and post procedure donor medical concerns and issues
Expert knowledge of apheresis techniques and performance for cellular product collection and donor care.
Ability to effectively communicate with all levels of associates, management, physicians, donors and their families/companions.
Must be able to maintain confidentiality.
Effective oral and written communication skills.
Ability to analyze, interpret, summarize, present results and perform standard data analysis Demonstrate strong organizational skills with attention to detail
Ability to lead and motivate individuals and groups of people toward the accomplishment of work and organizational goals.
Ability to plan and schedule tasks and projects and to maintain control of one’s own and others‘ workflow.
Ability to plan, design, and manage cellular therapy related projects within budget and on time.
Ability to work both independently and within teams
Must have proficient computer skills.
Demonstrated ability to multi–task
Detailed knowledge of FDA regulations, and AABB, FDA and FACT standards for cellular therapies.
Experience in preparing for and managing AABB, FDA, FACT and other regulatory inspections.
Must have good customer service and interpersonal skills.
Qualified Candidates should email resume and cover letter to jobs@tseworldwide.com