Manager, Medical Affairs, Omnipod 5 Franchise

Job not on LinkedIn

October 21

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

🍂 Massachusetts – Remote

Although this job is listed in Massachusetts, this company may be open to hiring remote in other states.

💵 $131.4k - $197.1k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

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Diabetes Youth Families

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Healthcare Insurance • Hardware

Diabetes Youth Families is a company that provides wearable insulin delivery solutions for diabetes management. Their primary products, such as the Omnipod 5 and Omnipod DASH systems, offer tubeless and automated insulin delivery for people with Type 1 and Type 2 diabetes, allowing users to manage their condition without the need for multiple daily injections. The systems integrate with continuous glucose monitoring (CGM) devices and can be controlled via compatible smartphones, enhancing the freedom and lifestyle of individuals living with diabetes. With a focus on reducing the burden of diabetes management, they offer financial assistance, support resources, and trial programs to help users adapt to their innovative solutions. The company emphasizes making life simpler while managing diabetes through technology-driven insulin management systems.

11 - 50 employees

Founded 1938

⚕️ Healthcare Insurance

🔧 Hardware

📋 Description

• Provide effective medical leadership and work collaboratively with the solutions-level Omnipod 5 Franchise teams to advise and guide the strategic objectives and operational decisions impacting global project implementation • Act as the medical expert, drawing on your experience and knowledge of diabetes management, established standards of care, published data and key opinion leader insights • Advise on medical risks related to discovered product defects and provide guidance on prioritization of fixes and post-market field actions • Shape medically sound product design requirements, critically assess systems and user error risks, and advise on risk control measures that ensure safe and effective use • Engage with clinical validation teams (Clinical Affairs, Human Factors, User Experience) to assist in data formulation to inform decision-making, confirmation of clinical outcomes, and confirmation of risk control effectiveness • Develop evidence generation strategies based on program objectives and cross functional inputs that result in data needed to support regulatory approval and commercial product claims • Translate available data into meaningful and robust clinical value stories that summarize clinical product performance • Gather and translate medical intelligence from key industry experts by engaging with the Medical Science Liaison team, investigators, and advisory boards • Develop and prepare medical go-to-market strategies and content for regional downstream teams that include professional education programs, medical conference presentations, and other healthcare provider/customer engagements • Establish professional learning needs and define educational requirements that ensure safe and effective use of Omnipod 5 and future products and features • Continually seek new opportunities to bring Medical Affairs value to the organization

🎯 Requirements

• At least 5 years of experience with medical affairs and/or medical strategy within medical device or pharmaceutical industry or related discipline • 2 or more years in clinical, industry, or research settings specifically related to the diabetes disease state and devices (i.e., automated insulin delivery, continuous glucose monitors) • Advanced degree with healthcare-related certification (Registered Nurse, Registered Dietitian, PharmD, Certified Diabetes Care and Education Specialist) • Proven success in Medical Affairs including development and implementation of medical strategies • In-depth understanding of diabetes (type 1 and type 2) including disease pathophysiology, treatment options, risks, and outcomes • Advanced knowledge of diabetes technology especially automated insulin delivery systems • Experience with research study methods and interpreting data • Working knowledge of relevant software programs [e.g., Microsoft Office Suite, Adobe Products, Medical Communication tools (Medical Information CRM, Promotional Material Review), etc.]

🏖️ Benefits

• Flexible working arrangements • Professional development opportunities