Senior Manager Medical Operations
About The Position
The Senior Manager, Medical Operations leads medical affairs activities across the in vitro diagnostics (IVD) product lifecycle, providing scientific and clinical expertise to support product development, regulatory compliance, risk management, and post-market activities. The role partners with R&D, Regulatory Affairs, Quality, Clinical, and Commercial teams to integrate clinical and medical considerations into business decisions and product strategy. The role provides medical and clinical subject-matter knowledge and support for new product development, on-market projects and activities, and risk management. It helps maintain a medical perspective throughout processes and initiatives to support the safety and performance of Abbott products across their lifecycle. The position is based in Abbott’s Core Labs Division in Irving, Texas, and includes travel approximately 15% of the time.
Requirements
- Doctorate degree (PhD) in life sciences, immunology, or clinical/translational research, or an MD.
- Minimum 7 years of experience.
Nice To Haves
- Advanced scientific, clinical, or medical background with expertise in IVD, diagnostics, medical devices, biotechnology, or life sciences.
- Strong knowledge of medical affairs, clinical evaluation, risk management, product development, and/or post-market surveillance activities.
- Experience supporting cross-functional teams in regulated healthcare environments.
- Ability to translate complex clinical and scientific data into actionable business recommendations.
- Strong leadership, stakeholder management, communication, and presentation skills.
Responsibilities
- Provide expert medical and clinical assessments of IVD products, including assay performance, clinical utility, and patient impact, and ensure medical requirements are incorporated into product development and lifecycle management.
- Serve as the Medical Operations subject-matter expert for new product development and on-market products, providing clinical review, evaluation, and strategic guidance.
- Lead clinical safety and risk assessments and contribute to benefit-risk evaluations, risk management documentation, and clinical evidence packages.
- Represent Medical Operations on cross-functional project teams and communicate medical insights and recommendations through presentations, reviews, and strategic discussions.
- Support investigations, CAPAs, complaints, and field actions through medical review and clinical impact assessments in collaboration with Medical Directors and Quality teams.
- Manage and prioritize Medical Operations activities, including objectives, workload distribution, and team performance.
- Develop and deliver training programs to strengthen medical, clinical, and scientific capabilities across the organization.
- Drive continuous improvement by evaluating and enhancing medical operations processes, procedures, and systems.
Benefits
- Career development opportunities with an international company.
- 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 a high employer contribution.
- Tuition reimbursement.
- Freedom 2 Save student debt program.
- FreeU education benefit, described as an affordable and convenient path to earning a bachelor’s degree.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
