Job Title: Medical Director (Center Physician)

Location: Hamilton, OH (Onsite; limited remote tasks may be possible as permitted)

Job Type: Contract | Full-Time (40 hours/week)

Duration: 24 months (potential to extend)

About the Role
Seeking a Medical Director to provide medical oversight at a plasma collection center, serve as the primary physician for regulatory reporting, and ensure compliance with FDA, CLIA/COLA, cGMP, and center policies. The role includes training and oversight of Medical Staff Associates, review of donor suitability, incident follow up, and participation in quality governance.

Key Responsibilities

• Serve as the primary physician for FDA reporting; monitor center medical compliance with applicable federal and state regulations, including Title 21 CFR.

• Fulfill or delegate CLIA roles (laboratory director/technical or clinical consultant) and ensure CLIA/COLA training, proficiency testing, and standardization logs are completed.

• Uphold cGMP standards through collaboration with center management and quality; maintain high medical standards and be onsite for agreed hours.

• Provide medical oversight and training for Medical Staff Associates and other physicians; evaluate and recommend certification completion.

• Review a sample of screening medical evaluations and unsuitable test result communications; sign Medical Staff Associate notebooks weekly.

• Conduct monthly meetings with Medical Staff Associates; document meetings; engage in weekly check ins with center leadership; participate on the Quality Assurance Team.

• Advise on donor suitability for serial plasmapheresis; conduct confidential donor interviews; address donor suitability questions from staff.

• Review and sign moderate/severe medical incident reports prior to donor re entry; review abnormal/normal SPE results and approve returns to donate as appropriate.

• Oversee medical supplies and emergency equipment; ensure confidentiality of all records.

• Support immunization programs (if applicable), including evaluations, approvals, presence during immunizations, and monthly reporting to divisional leadership.

• Perform center physician functions as needed: notify donors of unsuitable results, conduct screening evaluations, determine initial/continued donor suitability, and explain informed consents.

• Perform additional medically related services as requested.

Required Qualifications

• MD or DO from an accredited medical or osteopathic school.

• Active, unrestricted medical license in the State of Ohio (must be maintained).

• Minimum one year of residency training (MD or DO).

• Knowledge of infectious disease markers (e.g., HIV, HBV, HCV, syphilis) and donor health/safety considerations.

• Experience with regulated clinical/laboratory environments and applicable standards (FDA, CLIA/COLA, cGMP).

• Strong leadership, documentation, and communication skills; ability to train and mentor clinical staff.

Preferred Qualifications

• Prior plasma collection center or blood/plasma services experience.

• Demonstrated experience serving in CLIA laboratory director/consultant roles.

• Background participating in Quality Assurance teams and regulatory audits.

Key Skills
Center Physician Oversight | FDA/CLIA/COLA Compliance | cGMP | Donor Suitability | Medical Staff Training | Incident Review | Quality Assurance | SPE Result Review | Clinical Governance | Confidentiality