As an important member of our talented Hospital Patient Monitoring (HPM) Clinical Affairs the Senior Manager-Clinical Development is responsible for managing the day-to-day operations of Clinical Measurements & Specialty Monitoring clinical programs improving efficiency and simplifying the planning/execution of clinical plans.
Your role:
Responsible for planning direction and coordination of clinical programs and activities including overseeing Clinical Evidence planning and generation Clinical PIL tools process implementation ensuring compliance with applicable laws regulations and standards.
Ensures accountability for process execution system functionality backlog management and improvement initiatives.
Assists in the updates and enhancement of quality system processes for Clinical & Medical Affairs aligning with business strategies roadmaps and Informatics demands.
Serves as a primary point of contact between Clinical & Medical Affairs and other departments driving cross-function cooperation and ensuring stakeholder alignment.
Coordinates change requests and submissions ensuring all critical parties are aligned and changes are effectively implemented.
Works with a diverse global team emphasizing project management business analysis service management solution ownership and validation to achieve targeted outcomes.
Promotes application standardization through shared processes data harmonization and architectural compliance while fostering strong relationships.
Leverages expertise in Clinical & Medical Affairs to propose innovative ideas that support the function meeting their objectives.
Ensures compliance with training requirements and driving continuous improvement for the clinical programs.
Supports the development of the Clinical & Medical Affairs team by sharing resources knowledge and experience and leading initiatives that enhance the organization.
You should bring the following:
You have a minimum of 10 years combined experience in Medical Device Clinical Research and Medical Device development within FDA regulated OEM product environments.
You have proven experience in clinical validation measurement sustaining as well as design execution and oversight of clinical research planning and associated technologies/tools. Experience in Patient Monitoring (desired).
You have a minimum of 3 years experience in Project/Program management and/or Team leadership with proven experience in budgeting training staff development resource allocation continuous improvement etc.
You have a detailed understanding of Clinical & Medical Affairs leveraging expertise to propose innovative ideas providing meaningful input and contribute to senior leadership discussions.
You have a deep understanding of Health Care Research methodology regulations laws and guidance in major markets such as EU USA UK AUS Japan and China.
You have proven experience in building/Cultivating strong working relationships and partnerships with business stakeholders/functions and influencing internal/external service providers towards achieving strategic objectives.
You have a minimum of a Bachelors Degree (Required) in Biology Health Science MPH Nursing or equivalent. Masters/PhD desired. Six Sigma Safe Agile PMP certifications desired.
You must be able to successfully perform the following minimum Physical Cognitive and Environmental job requirements with or without accommodation for this position.
Philips benefits for you:
Annual leave: 30 days
Mobility and devices: subsidized Germany ticket (instead of 58 only 3510) leasing opportunities for private use (bicycles cars smartphones)
Philips University & Philips in Balance: Wide range of professional training courses and for personal development & Healthcare
Philips Pension Fund: Employer-funded pension plan
Partnerzeit two paid weeks off after your partner has given birth
Philips MyShop: Discount on Philips products
Meals: Free drinks and low prices in our canteen and Café Philistro
Culture: Informal culture a paid day for voluntary work various team/cultural activities (on sustainability diversity ...) etc.
How We Work Together
We believe that we achieve better results when we work together rather than apart. For this role this means to be on-site at least 3 days a week.
About Philips
We are a health technology company. We built our entire company around the belief that every human matters and we wont stop until everybody everywhere has access to the quality healthcare that we all deserve. With patient safety and Quality as our fundamental premise we focus on regulatory requirements and quality standards in our daily work. Do the work of your life to help the lives of others.
Learn more about our business.
Discover our rich and exciting history.
Learn more about our purpose.
If youre interested in this role and have many but not all of the experiences needed we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.
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Required Experience:
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