Director, Medical Affairs – Molecular Diagnostics

Abbott • Des Plaines, IL

3d • Onsite

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 the medical expert in molecular diagnostics and laboratory medicine, partnering across multiple functions to 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. Through expertise in the clinical application of molecular diagnostic technologies and methods, the individual helps drive the development of innovative diagnostic solutions that improve patient care and support healthcare providers worldwide.

Requirements

• MD degree or equivalent.
• Minimum 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.
• Demonstrated 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 across Abbott Molecular's diagnostic portfolio by evaluating emerging clinical evidence, diagnostic technologies, biomarkers, disease management trends, and evolving standards of care that 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 supporting product development and commercialization.
• Lead the development and review of Intended Use statements, clinical claims, and supporting evidence to ensure 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 that product designs, performance claims, and intended use statements are medically appropriate, scientifically supported, and clinically meaningful.
• Provide medical leadership for clinical evidence generation activities, including study design, performance evaluation strategies, endpoint selection, clinical claims development, product labeling, and evidence plans to support product development, regulatory submissions, and lifecycle management activities.
• 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 to support global regulatory submissions and interactions with health authorities, including FDA, IVDR requirements, and interactions with global regulatory authorities.
• Partner with the Market Access team to support reimbursement strategies, including engagement with CMS, MACs, commercial payers, and other healthcare stakeholders.
• Provide medical leadership for evidence generation and assessment to support coding, coverage, and payment and patient access to Abbott Molecular's diagnostic solutions.
• Participate in risk management activities throughout the product lifecycle, 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, including authoring and reviewing HHAs, participating in CAPA investigations, supporting root cause analyses, evaluating potential patient impact, and recommending appropriate risk mitigation activities.
• Provide medical oversight for post-market surveillance activities, including the review of complaint trends, safety information, scientific literature, real-world performance data, and the development of medical assessments and reports supporting product lifecycle management and regulatory compliance.
• Support regulatory inspections, quality audits, health authority responses, and other compliance-related activities as required.
• Apply expertise in molecular diagnostics, laboratory medicine, and disease biology to support 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.
• Effectively communicate complex medical concepts to diverse audiences.
• Foster alignment among stakeholders with differing clinical, technical, regulatory, quality, and commercial perspectives.
• Demonstrate the highest standards of integrity, ethics, and professional judgment.
• Influence global portfolio strategy by integrating clinical practice insights, scientific evidence, market needs, and regulatory requirements to advance innovative molecular diagnostic solutions.

Benefits

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement
• the Freedom 2 Save student debt program
• FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree

What This Job Offers

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