Sr. Manager, Medical Affairs & Clinical Studies
Carl Zeiss Meditec, Inc. Hartford, CT
- Expired: over a month ago. Applications are no longer accepted.
The Sr. Manager, Post-Approval Studies is responsible for leading the strategy and execution of post-approval clinical activities to support the refractive business. This individual will play the lead role in identifying needs, aligning study budgets, developing, and implementing study activities to support global marketing and professional education. This is a technical and highly networked position that will have great impact on customer interaction and communications, with global internal and external visibility.
• Manages clinical and operational leadership on the proper conduct of post-approval trials for global business, including the design and implementation of these studies, writing protocols/amendments and proper IRB submission, design of data collection systems, financial structure, and preparation of final reports and deliverables
• Manages study budget for, and allocates resources as appropriate and determined by business needs in alignment with global medical affairs & professional education objectives
• Manages investigator-initiated peer-review publications (through to submission) for Post-Approval supported investigator studies
• Key interface with global key opinion leaders in OPT, build advocacy with KOL’s by engaging in ideation and study activities
• Attend key global congresses/symposia/advisory board meetings
• Develop and maintain strong working relationships with internal stakeholders, such as Professional Education, Marketing, Clinical Affairs, and Research & Development, to understand Post-Approval study needs and identify needed collaborations and synergies/overlap across departments
• Build strong relationship with medical community, including teaching institutions and related physicians with a scientific approach focused on identifying needs and providing solutions as pertaining to relevant Post-Approval study activities
• Helps establish & support long-term post-approval strategies and goals
• Responsible for implementation and maintenance of Medical Affairs-related Policies and Procedures
• Provide post-approval clinical activity support for the global surgical and refractive business as needed.
• Medical/scientific background and education highly desirable (OD or similar)
• 6+ years’ experience in OPT industries, such as cataract, refractive, glaucoma and retina spaces
• Experience developing and managing a post-approval or clinical trials
• Highly motivated and results-oriented with strong business understanding to align with overall organizational goals
• Familiarity with the principles of clinical research
• Ability to interpret and present clinical data and other complex information
• Proficiency in Word, Excel, PowerPoint,
• Ability to manage multiple projects at once
• Excellent written and verbal skills
• Embracing of core ZEISS mission and those of Medical Affairs & Professional Education
• Experience working within an international company; able to operate in a matrix team-oriented structure
• International travel required (minimum 30% of time)
Carl Zeiss Meditec, Inc.Why Work Here?
One of the global leaders in the optical and optoelectronic industries and has been contributing to technological progress for 175 years.
ZEISS is one of the world’s leading innovators in the design and development of medical devices. We create and supply cutting-edge technologies and application-oriented solutions for ophthalmology and microsurgery.
5160 Hacienda Drive DublinHartford, CT