Director, Medical Affairs – Molecular Diagnostics

Abbott • Lake Forest, IL

1d • $149,300 - $298,700

About The Position

The Director, Medical Affairs – Molecular Diagnostics provides medical leadership for the development, regulatory approval, commercialization, and lifecycle management of Abbott Molecular’s global diagnostic portfolio. The role serves as a medical expert in molecular diagnostics and laboratory medicine, partnering across functions to help ensure products are clinically relevant, scientifically robust, and compliant with global regulatory requirements.

The Medical Director contributes to product strategy, intended use and claims development, clinical evidence generation, regulatory submissions, reimbursement strategy, risk management, quality activities, and post-market surveillance. By applying expertise in the clinical use of molecular diagnostic technologies and methods, the role supports innovative diagnostic solutions intended to improve patient care and support healthcare providers worldwide.

The position also provides medical and scientific guidance to cross-functional teams and business leaders, communicates complex medical concepts to diverse audiences, and helps align stakeholders with differing clinical, technical, regulatory, quality, and commercial perspectives. It requires sound judgment, scientific credibility, evidence-based recommendations, and high standards of integrity, ethics, and professional judgment.

Requirements

• MD, DO, MBBS, or equivalent medical degree.
• At least 5 years of industry experience in IVD, biotechnology, pharmaceutical, or medical device organizations, with demonstrated leadership in product development, clinical affairs, medical affairs, regulatory affairs, or related functions.
• Demonstrated expertise in molecular diagnostics, laboratory medicine, and the clinical application of molecular technologies.
• Experience supporting diagnostic product development, regulatory submissions, and lifecycle management activities.
• Experience reviewing and interpreting clinical and scientific evidence supporting diagnostic claims and regulatory submissions.
• Strong understanding of global regulatory requirements applicable to IVD products, including FDA and IVDR regulations.
• Knowledge of healthcare reimbursement, coding, coverage, and payment processes relevant to molecular diagnostics and IVD products, including experience supporting interactions with CMS, MACs, and commercial payers.
• Emotional intelligence, strong communication skills, and the ability to influence, collaborate with, and build trust across highly matrixed organizations.

Nice To Haves

• Residency in Pathology is highly preferred.
• Fellowship training in Molecular Genetic Pathology or a related subspecialty.
• Experience in one or more clinical areas relevant to Abbott Molecular’s portfolio, including infectious diseases, transplant diagnostics, women’s health, oncology, or precision medicine.

Responsibilities

• Serve as the medical subject matter expert for Abbott Molecular’s diagnostic portfolio.
• Provide medical and scientific leadership by evaluating clinical evidence, diagnostic technologies, biomarkers, disease management trends, and standards of care to inform product strategy, development, regulatory approval, commercialization, and post-market activities.
• Partner with cross-functional teams to define clinical use cases, target patient populations, specimen requirements, intended use claims, clinical utility, clinical differentiation, and evidence strategies.
• Lead development and review of Intended Use statements, clinical claims, and supporting evidence, ensuring products are clinically meaningful, scientifically supported, reimbursable, and aligned with regulatory requirements.
• Contribute to the development and review of User Needs, CRDs, PRDs, IFUs, labeling, and other product development documentation.
• Ensure product designs, performance claims, and intended use statements are medically appropriate, scientifically supported, and clinically meaningful.
• Provide medical leadership for clinical evidence generation, including study design, performance evaluation strategies, endpoint selection, claims development, product labeling, and evidence plans.
• Review and provide medical oversight of clinical, scientific, and regulatory documentation supporting product development, performance evaluation, and global regulatory submissions.
• Collaborate with Regulatory Affairs and Clinical Affairs on global regulatory submissions and health authority interactions, including FDA and IVDR requirements.
• Partner with Market Access on reimbursement strategies and engagement with CMS, MACs, commercial payers, and other healthcare stakeholders; support evidence generation and assessment for coding, coverage, payment, and patient access.
• Participate in lifecycle risk management, including hazard analyses, benefit-risk assessments, Risk Management Files, and FMEAs.
• Provide medical assessment of product performance issues, design changes, complaints, adverse events, field actions, and emerging safety signals; author or review HHAs, participate in CAPA investigations, support root cause analyses, evaluate potential patient impact, and recommend risk mitigation.
• Provide medical oversight for post-market surveillance, including review of complaint trends, safety information, scientific literature, real-world performance data, and development of medical assessments and reports.
• Support regulatory inspections, quality audits, health authority responses, and other compliance activities as required.
• Apply expertise in molecular diagnostics, laboratory medicine, and disease biology to product development, regulatory, reimbursement, and lifecycle management decisions.
• Exercise sound judgment in balancing clinical, technical, regulatory, quality, and business considerations.
• Collaborate with and influence cross-functional teams and business leaders through medical expertise, scientific credibility, and evidence-based recommendations.
• Communicate complex medical concepts to diverse audiences and foster alignment among stakeholders.
• Demonstrate integrity, ethics, and professional judgment.
• Influence global portfolio strategy by integrating clinical practice insights, scientific evidence, market needs, and regulatory requirements.

Benefits

• Employees may qualify for free medical coverage in the Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• Retirement savings plan with high employer contribution.
• Tuition reimbursement.
• Freedom 2 Save student debt program.
• FreeU education benefit, an affordable and convenient path to earning a bachelor’s degree.
• Career development opportunities with an international company.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree