Global Director, Molecular Diagnostics Medical Affairs

Abbott Laboratories; Des Plaines (IL); On-site; USD 149,000 - 299,000; Full time

Job summary

Abbott Molecular is seeking a Director, Medical Affairs – Molecular Diagnostics to lead medical and scientific activities for the global diagnostic portfolio in molecular diagnostics and laboratory medicine.

You will drive evidence generation, define clinical use cases, and oversee regulatory submissions to ensure scientifically robust, compliant outcomes. This senior role requires strategic collaboration across functions to improve patient care globally.

Qualifications

• MD degree or equivalent.
• Minimum 5 years of industry experience in IVD/medical devices with leadership.
• Expertise in molecular diagnostics and laboratory medicine.
• Experience supporting regulatory submissions and lifecycle management.
• Strong understanding of global regulatory requirements (FDA, IVDR).
• Knowledge of reimbursement, coding, and payer interactions.
• Excellent communication and collaboration across matrixed teams.
• Influence portfolio strategy with clinical and regulatory insights.

Responsibilities

• Serve as medical SME for Abbott Molecular's diagnostic portfolio.
• Provide medical and scientific leadership evaluating evidence and technologies.
• Define clinical use cases, patient populations, and evidence strategies.
• Develop and review Intended Use statements and clinical claims.
• Contribute to user needs, CRDs, PRDs, IFUs, labeling.
• Ensure designs and claims are medically appropriate and supported.
• Lead clinical evidence generation, study design, and endpoints.
• Review documentation supporting regulatory submissions.
• Collaborate with regulatory and market access teams.
• Support global regulatory interactions and inspections.
• Provide medical oversight for post-market surveillance.

Skills

Molecular diagnostics

Clinical leadership

Regulatory knowledge

Medical affairs leadership

Cross-functional collaboration

Education

MD degree

Residency in Pathology (preferred)

Job description

Abbott Molecular is seeking a Director, Medical Affairs – Molecular Diagnostics to lead medical and scientific activities for the global diagnostic portfolio in molecular diagnostics and laboratory medicine.

You will drive evidence generation, define clinical use cases, and oversee regulatory submissions to ensure scientifically robust, compliant outcomes. This senior role requires strategic collaboration across functions to improve patient care globally.