Senior Director, Molecular Diagnostics Medical Affairs

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

Benefits offered by this job

Health benefits

Tuition reimbursement

Job summary

Abbott seeks a Director of Medical Affairs – Molecular Diagnostics to lead medical strategy across Abbott Molecular's diagnostic portfolio. You will align clinical evidence, regulatory requirements, and market access to shape product development, labeling, and post-market activities.

Role requires MD/DO/MBBS with 5+ years in IVD or related fields, strong regulatory and reimbursement knowledge, and ability to influence across matrixed teams. Abbott offers global impact and diverse benefits.

Qualifications

• MD, DO, MBBS or equivalent medical degree.
• Minimum 5 years of industry experience in IVD, biotechnology, pharmaceutical, or medical device organizations, with 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.
• Influence global portfolio strategy by integrating clinical practice insights, scientific evidence, market needs, and regulatory requirements to advance innovative molecular diagnostic solutions.

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.

Job description

Abbott seeks a Director of Medical Affairs – Molecular Diagnostics to lead medical strategy across Abbott Molecular's diagnostic portfolio. You will align clinical evidence, regulatory requirements, and market access to shape product development, labeling, and post-market activities.

Role requires MD/DO/MBBS with 5+ years in IVD or related fields, strong regulatory and reimbursement knowledge, and ability to influence across matrixed teams. Abbott offers global impact and diverse benefits.