Director, Medical Affairs – Molecular Diagnostics

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare with leading businesses and products in diagnostics medical devices nutritionals and branded generic medicines. Our 122000 colleagues serve people in more than 160 countries.

WORKING AT ABBOTT:

At Abbott you can do work that matters grow and learn care for yourself and family be your true self and live a full life. Youll also have access to:

• Career development with an international company where you can grow the career you dream of.
• 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 and FreeU education benefit - an affordable and convenient path to getting a bachelors degree
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity working mothers female executives and scientists.

THE OPPORTUNITY:

The Director Medical Affairs Molecular Diagnostics provides medical leadership for the development regulatory approval commercialization and lifecycle management of Abbott Moleculars 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.

WHAT YOULL WORK ON:

• Serve as the medical subject matter expert for Abbott Moleculars diagnostic portfolio.
• Provide medical and scientific leadership across Abbott Moleculars 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 Moleculars 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.

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.

REQUIRED QUALIFICATIONS:

• 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.
• Influence global portfolio strategy by integrating clinical practice insights scientific evidence market needs and regulatory requirements to advance innovative molecular diagnostic solutions.

PREFERRED QUALIFICATIONS:

• 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 Moleculars portfolio including infectious diseases transplant diagnostics womens health oncology or precision medicine.

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Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer committed to employee diversity.

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The base pay for this position is

$149300.00 $298700.00

In specific locations the pay range may vary from the range posted.

Medical & Scientific Affairs

AMD Molecular

United States > Des Plaines : DP01

Standard

Not specified

Not Applicable

Keyboard use (greater or equal to 50% of the workday)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: EEO is the Law link - Espanol: Experience:

Director