Associate Director, Digital Endpoint Lead

The Patient Innovation Lead will handle assessment, validation, and implementation of novel technologies to increase trial effectiveness and reduce trial burden to the patient for Regeneron’s clinical research trials. The Patient Innovation Lead maintains the lab space that identifies, develops, and delivers fit-for-purpose solutions to meet the needs of the Regeneron portfolio as well as developing novel technologies based upon future organizational needs. This role requires an entrepreneurial approach, strong analytical and research skills, relationship management skills, presentation skills, creative thinking and problem-solving skills, and experience with the clinical trial process. Provides oversight at program level and clinical research studies for Innovation aspects in collaboration with the study team. Functions as Subject Matter Expert (SME) advising internal clinical study teams on best practices in technology adoption to ensure regulatory compliance and data quality. This role will liaise with internal and external collaborators, identify and drive alliances and ventures under the supervision of the Sr. Director, Clinical Outcomes Assessment & Patient Innovations.

• Responsible for the assessment and delivery of new technologies, methodologies or services for one or more clinical research trials with quality and compliance
• Continuously pursue new opportunities that may benefit clinical trials and present solutions to internal partners
• Experiment with research methods, processes and instruments
• Expand use of wearables.
• Identify new ways for understating patient mobility impact through wearables
• Collect data through wearables/sensors in support of existing self reported data
• Introduce structured group ideation sessions to identify and pursue new opportunities to advance clinical trials and propel research of new technologies based on program needs
• Partner with leading institutions in research (startups, academia, CRO) to collaborate on concept development and new technology adoption
• Lead collaborations with internal partners and vendors to strategize effective innovative solutions
• Provide input into protocol development as it relates to sensors or other clinical technologies
• Build business cases, develop hypothesis, plan pilot and concept testing, implement surveys to progress innovative approaches at a trial, program or corporate level
• Drives the strategy and oversight for vendor selection and management within a clinical program(s)
• Develop best practices to support adoption of different innovation technologies
• Set qualification requirements for vendors supporting innovations
• Use interpersonal, negotiating, and project management skills to drive end to end project development and handle risk as related to services technologies.
• Support and supervise financial components related to Innovation for each study
• Collaborate with key internal team members, including statistics and data management on data specifications, standards, and transfers
• Identifies and recommends changes to practices and policies, including initiating and participating in strategic projects, initiatives, and continuous improvement projects within Global Development
• Apply problem solving strategies to issues and maintain issue tracking documentation to supervise progress and ensure timely resolution to issues
• Communicate clinical innovations in eSource modalities to team members and broader organization
• Facilitates and contributes to study level lessons learned
• Recommends and participates in cross-functional and departmental process improvement initiatives
• May be responsible for direct supervision of staff

Bachelors degree and minimum of 10 years relevant industry experience. PhD preferred with 8+ years of relevant industry experience.

Has knowledge of technologies and services available in a clinical setting

• Demonstrate knowledge of general system development processes
• Demonstrated interpersonal & leadership skills
• Proven knowledge of or experience with clinical trial development process and use of clinical technologies
• Ability to understand and implement the strategic direction and guidance for respective clinical studies
• A data driven approach by planning, gathering information, mitigating risks, and implementing
• Effective interpersonal skills (verbal, written and presentation abilities)
• Ability to independently perform and handle multiple tasks at one time and meet deadlines in a sophisticated environment working both internal to Regeneron and with external vendors
• Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
• Ability to influence and negotiate
• An awareness of relevant industry trends
• Demonstrated vendor management experience
• Technical proficiency in trial management systems and Microsoft Project Server
• Knowledge of ICH/GCP and regulatory guidelines/directives
• Effective project management skills, cross-functional team leadership and organizational skills
• May require up to 25% Travel

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.