Patient Innovation Lead - Associate Director
Regeneron Pharmaceuticals Inc

Job Info

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The Patient Innovation Lead will be responsible for assessment, validation, and implementation of novel technologies to maximize trial effectiveness and reduce trial burden to the patient for Regeneron's clinical research trials. As the Lead you may have direct responsibilities for maintaining the lab space which owns identifying, developing, and delivering fit-for-purpose solutions to meet the needs of the Regeneron portfolio as well as developing novel technologies based upon future organizational needs. You will provide oversight at the program level and individual clinical research studies for Innovation aspects in collaboration with the study teams. As the lead you unctions as SME advising internal clinical study teams on ideal methodologies in technology adoption to ensure regulatory compliance and data quality.

A typical day in this role might include:
• Being accountable for the assessment and successful delivery of new technologies, methodologies or services for one or more clinical research trials with quality and compliance
• Continuously pursuing new opportunities that may benefit clinical trials and present solutions to internal partners
• Experimenting with research methods, processes and instruments
• Expanding use of wearables:
1. Identify new ways for understating patient functional mobility impact through wearables
2. Collect objective data through wearables/sensors in support of existing self reported data
• Introducing structured group ideation sessions to:
1. Propel research of new technologies based on program needs
2. Identify and pursue new opportunities to advance clinical trials
• Maintaining cutting edge knowledge of developments in clinical measurements, the latest innovations, clinical trial industry news, and advancing regulatory trends through conference attendance, open forums and developing external relationships
• Partnering with leading institutions in research (startups, academia, CRO) to collaborate on concept development and new technology adoption
• Communicating with internal partners to understand clinical trial needs and areas of opportunities
• Leading collaborations with internal partners and vendors to strategize effective innovative solutions
• Providing input into protocol development as it relates to sensors or other clinical technologies
• Crafting business cases, developing hypothesis, planning pilot and concept testing, and executing surveys to progress innovative approaches at a trial, program or corporate level
• Driving the strategy and oversight for vendor selection and management within a clinical program(s)
• Developing global ideal methodologies to support adoption of different innovation technologies
• Setting qualification requirements for new vendors supporting innovations
• Using interpersonal, negotiating, and project management skills to drive end to end project development and handle risk as related to new services technologies.
• Supporting and monitoring financial components related to Innovation for each study
• Collaborating with statistics and data management teams on data specifications, standards, and transfers
• Identifying and recommending changes to practices and policies, including initiating and participating in strategic projects, initiatives, and continuous improvement projects within Global Development
• Applying problem solving strategies to issues and maintain issue tracking documentation to monitor progress and ensure timely resolution to critical issues
• Presenting clinical innovations in eSource modalities to partners and broader organization
• Potentially having responsibility for direct supervision of staff
• Ability to travel up to 25% travel
This role may be for you if:
You have knowledge of technologies and services available in a clinical setting
You have demonstrated knowledge of general system development processes
You have an entrepreneurial approach with strong analytical and research and presentation skills
You have knowledge of or experience with clinical trial development process and use of clinical technolgoies
You have the ability to understand and implement the strategic direction and guidance for respective clinical studies
You have a data driven approach by planning, gathering information, mitigating risks, and executing
You can independently perform and manage multiple tasks at one time and meet deadlines in a complex environment
To be considered, you'll need a Master's Degree in 10 years of related experience. A Bachelor's Degree and at least 13 years of experience might be considered in lieu of an advance degree. Technical proficiency in trial management systems and Microsoft Project Server is vital. You'll also need to have knowledge of ICH/GCP and regulatory guidelines/directives.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

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