Commercial Medical Director

Job Title : Medical Director (Center Physician)

Location : Jackson MI (Onsite; limited remote tasks may be permitted)

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

Duration : 24 months (potential multi-year extension)

Openings : 1

About the Role

Seeking a Medical Director to provide medical oversight at a plasma collection center ensure regulatory compliance (FDA CLIA / COLA cGMP) and lead the Center Medical Staff. The role serves as primary physician for regulatory reporting oversees donor suitability and incident reviews and supports training quality and governance activities.

Key Responsibilities

Serve as primary physician for FDA reporting; monitor medical compliance with applicable federal / state regulations including Title 21 CFR.

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

Uphold cGMP standards in partnership with center management and quality; be onsite for agreed hours.

Provide medical oversight and training to Medical Staff Associates (MSAs) and physicians; evaluate newly trained MSAs and recommend certification completion.

Review and sign MSA notebooks weekly; sample-review screening evaluations and unsuitable test result communications.

Hold monthly meetings with MSAs; document discussions; participate in weekly center leadership check-ins and Quality Assurance Team activities.

Advise on donor suitability for serial plasmapheresis; conduct confidential donor interviews; respond to staff inquiries on donor eligibility.

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

Oversee medical supplies and emergency equipment; maintain strict confidentiality of all records.

Support immunization and hyper-immune programs where applicable (qualifications approvals presence during immunizations and monthly reporting).

Perform center physician duties as needed : notify donors of unsuitable results perform screening medical evaluations determine initial / continued donor suitability and explain informed consent.

Perform additional medically related services as requested.

Required Qualifications

MD or DO from an accredited medical or osteopathic school.

Active unrestricted medical license in Michigan (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 standards.

Experience in regulated clinical / laboratory environments (FDA CLIA / COLA cGMP).

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

Preferred Qualifications

Lab Director qualifications preferred.

Prior experience in plasma / blood collection operations.

Demonstrated experience serving in CLIA laboratory leadership / consultant roles.

Background in quality assurance participation and regulatory audits.

Key Skills

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

Interview & Work Details

Interview Format : Webcam or in-person.

Schedule : Full-time; onsite presence for agreed hours. Limited remote activities may be permitted per policy.

Key Skills

EMR Systems,Post Residency Experience,Occupational Health Experience,Clinical Research,Managed Care,Primary Care Experience,Medical Management,Utilization Management,Clinical Development,Clinical Trials,Leadership Experience,Medicare

Employment Type : Full Time

Experience : years

Vacancy : 1