Director, Medical Affairs – Molecular Diagnostics
Abbott
Summary
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.
Job description
The Opportunity
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.
What You'll Work On
- Serve as the medical subject matter expert for Abbott Molecular's diagnostic portfolio.
- Provide medical and scientific leadership by evaluating emerging clinical evidence, diagnostic technologies, biomarkers, disease management trends, and evolving standards of care.
- 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 the development and review of Intended Use statements, clinical claims, and supporting evidence.
- Contribute to the development and review of User Needs, CRDs, PRDs, IFUs, labeling, and other product development documentation.
- Provide medical leadership for clinical evidence generation activities, including study design, performance evaluation strategies, endpoint selection, and evidence plans.
- Review and provide medical oversight of clinical, scientific, and regulatory documentation supporting product development and global regulatory submissions.
- Collaborate with Regulatory Affairs and Clinical Affairs to support global regulatory submissions and interactions with health authorities, including FDA and IVDR requirements.
- Partner with the Market Access team to support reimbursement strategies, including engagement with CMS, MACs, and commercial payers.
- 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.
- Provide medical oversight for post-market surveillance activities, including complaint trends, safety information, scientific literature, and real-world performance data.
- Support regulatory inspections, quality audits, health authority responses, and other compliance-related activities.
Medical Expertise and Problem-Solving
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.
Leadership Activities
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.
Requirements
- MD, DO, MBBS, or equivalent medical degree
- Minimum 5 years of industry experience in IVD, biotechnology, pharmaceutical, or medical device organizations
- 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
- Experience supporting interactions with CMS, MACs, and commercial payers
- Demonstrated emotional intelligence, strong communication skills, and ability to influence and collaborate across highly matrixed organizations
- Ability to influence global portfolio strategy by integrating clinical practice insights, scientific evidence, market needs, and regulatory requirements
- Residency in Pathology is highly preferred
- Fellowship training in Molecular Genetic Pathology or a related subspecialty
- Experience in clinical areas relevant to Abbott Molecular's portfolio, including infectious diseases, transplant diagnostics, women's health, oncology, or precision medicine
Benefits
- Medical Coverage
- Retirement Savings Plan
- Tuition Reimbursement
- Student Debt Program
- Education Benefit
- Career Development
Company overview
Abbott Laboratories is a global healthcare leader with a 135-year legacy of innovation, dedicated to helping people live healthier, fuller lives through life-changing technologies and products. Headquartered in Abbott Park, Illinois, the company operates in more than 160 countries with a workforce of approximately 114,000 professionals. Abbott's diversified portfolio spans four core business segments: medical devices, diagnostics, nutrition products, and branded generic pharmaceuticals. The company is particularly renowned for its groundbreaking medical devices including cardiovascular technologies, diabetes management systems like the FreeStyle Libre continuous glucose monitor, neuromodulation devices for chronic pain, and the AVEIR DR dual chamber leadless pacemaker system. In diagnostics, Abbott has been instrumental in developing critical tests, including the first licensed HIV test in 1985 that helped secure blood supply safety. The company's nutrition division produces leading infant formulas like Similac, while its pharmaceutical business provides quality branded generic medicines. Abbott consistently ranks among Fortune's Most Admired Companies and maintains a strong commitment to sustainability and corporate responsibility, making it a trusted partner in advancing global healthcare.