Medical Director

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