Medical Director, Apheresis
Medical Director, Apheresis
San Diego, CA
Sanguine Biosciences is accelerating personalized medicine research by empowering patients with their healthcare data and making it as easy as possible for them to participate in the medical research process. We partner with patients and pharmaceutical companies to accelerate precision medicine R&D by securely and efficiently collecting and providing patient samples and relevant health data. We are helping thousands of researchers at 20 of the top 40 global pharmaceutical and biotechnology companies increase the speed and quality at which they are conducting their research. For the past two years, Sanguine received the prestigious designation as a “Great Places to Work” company. It is an exciting time; our biotech company is growing quickly and needs the best team members to join us.
About the Role:
Sanguine is seeking a physician to manage its Clinical Apheresis Site , which will focus on cell therapy collections. This leader will provide medical support for the collection center that procures cells for Sanguine's Clinical and Commercial Cell Therapies on a part time basis. This position is expected to be involved both in the development of sound protocols and procedures, and in providing medical support for all aspects of the clinical operations of the center and the research protocols performed therein.
Medical Advisory (50%)
- Serve as Principal Investigator for collection research protocols and consents
- Responsible for medical oversight of the Clinical Apheresis Operations
- Provide an active and clear medical license under which Apheresis Center will operate
- Work with Apheresis Team to develop research protocols and consents, Apheresis policies and procedures, donor selection parameters including inclusion and exclusion criteria, safety protocols, and any other necessary operational guidance requiring medical input
- Provide medical guidance during the selection of healthy and disease-specific donors
- Notify prospective donors of any positive viral screening results
- Provide clinical counseling
- Refer/recommend prospective donors for clinical follow-up as appropriate
- Provide Physician signature for Apheresis orders
- Provide medical intervention for donor symptoms or adverse events occurring during the apheresis procedure
- Respond to donor post-donation complaints and issues
- Review and approve changes/updates to existing procedures, protocols and systems as needed and at least annually
- Serve as member of the quality committee for review of adverse events and incidents, review of unplanned protocol deviations, and approval of planned deviations, as well as other quality program tasks as needed
- Provide input for drafting relevant sections of regulatory filings and work with Apheresis Operations team to prepare for regulatory audits, as required
- Foster team health and engagement, and provide medical support and advice for all aspects of apheresis operations
- M.D., D.O., or equivalent degree
- Active and clear medical license(s)
- Have documented training in apheresis in a relevant accredited post-graduate medical education (e.g. transfusion medicine, hematology/oncology, nephrology, clinical pathology); AND have documented participation in continuing education specifically related to Therapeutic Apheresis or Donor Apheresis offered by American Society for Apheresis, AABB, or equivalent organizations; AND are board certified or board eligible; AND have participated in a minimum of 50 Therapeutic and or Donor Apheresis procedures involving 15 different patients (Note: participation should be documented).
- Have knowledge of applicable Federal and regional Regulations
Sanguine is an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.