Sr Manager Medical Affairs, Omnipod 5 Franchise (Remote/Flexible)
Insulet - Acton, MA
posted about 1 month ago
About the position
To expand access to Insulet's life changing technology, it is crucial to advance our product features, and continually grow our body of evidence to understand who, and how people with diabetes experience the clinical and quality of life benefits while using the Omnipod 5 System. In this unique role, you will report to the Sr. Director of Medical Affairs, Omnipod 5 Franchise, and be accountable for the Omnipod 5 System's clinical value story that will be communicated to regulatory bodies, payors, healthcare providers and end users around the world. Collaborating with cross-functional and regional teams, you will ensure product features, labeled indication, clinical messages and educational content meet the needs of target audiences. This position will require you to think critically, and act as a strategic medical leader.
Responsibilities
- Lead the development and execution of the strategic medical plans, including evidence generation, data dissemination and HCP engagement activities that align with local regulatory, commercial and market access priorities within the Omnipod 5 portfolio.
- Develop and prepare medical go to market strategies and content for global downstream teams that include professional education programs, medical conference presentations, and other healthcare provider/customer engagements.
- Bring effective medical leadership and work collaboratively within the Omnipod 5 Franchise to independently advise and guide the strategic objectives and operational decisions impacting key Omnipod 5 projects.
- Act as a disease state expert, drawing on your experience and knowledge of diabetes management, established standards of care, published data and key opinion leader insights.
- Define cross-functional study objectives and support design of clinical study protocols that deliver data needed to support regulatory approval, market access and market adoption of the Omnipod 5 System.
- Engage closely with clinical validation teams (Clinical Affairs, Human Factors, User Experience) to formulate data to inform decision-making, confirmation of clinical outcomes, and confirmation of risk control effectiveness.
- Translate available data into meaningful and robust insights and conclusions that support regulatory requirements, commercial claims, and product value messaging.
- Gather and translate medical intelligence from industry experts by engaging with regional counterparts, investigators, international key opinion leaders and advisory boards.
- Establish professional learning needs and define educational requirements that ensure safe and effective use of Omnipod 5 and related products.
- Identify resource needs necessary to support assigned projects to meet the business objectives.
- Continually seek new opportunities to bring Medical Affairs value to the organization.
- Supervise and mentor Medical Affairs staff as appropriate.
Requirements
- 10+ years of experience with medical affairs and/or medical strategy within medical device or pharmaceutical industry or related discipline or equivalent education.
- 5+ years in clinical, industry, or research settings that specifically relate to the diabetes disease state and devices (i.e., insulin pumps, continuous glucose monitors) or equivalent combination of education and experience.
Nice-to-haves
- Advanced degree with healthcare related certification (Registered Nurse, Registered Dietitian, PharmD, Certified Diabetes Care and Education Specialist).
Benefits
- 100% remote working arrangements
- Competitive salary range of $141,500.00 - $212,600.00
