Senior Manager, Patient Innovation Lead

Location
Sleepy Hollow, NY, United States
Posted
Mar 21, 2019
Ref
15590BR
Required Education
Masters Degree/MBA
Position Type
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary:
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. The Patient Innovation Lead may have direct responsibilities for maintaining the lab space which is responsible for 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. The Patient Innovation Lead requires an entrepreneurial mindset, strong analytical and research skills, relationship management skills, presentation skills, creative thinking and problem-solving skills, and experience with the clinical trial process. The Patient Innovation Lead will be expected to liase with internal and external collaborators, identify and drive external alliances and ventures under the supervision of the Director, Clinical Outcomes Assessment & Innovations.

Job Duties:

• Responsible & 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 pursue new opportunities that may benefit clinical trials and present solutions to internal stakeholders

• Experiment with research methods, processes and instruments

• Expand use of wearables:
o Identify new ways for understating patient functional mobility impact through wearables
o Collect objective data through wearables/sensors in support of existing self reported data

• Introduce structured group ideation sessions to:
o Identify and pursue new opportunities to advance clinical trials
o Propel research of new technologies based on program needs

• Maintain cutting edge knowledge of developments in clinical measurements, latest innovations, clinical trial industry news, and advancing regulatory trends through conference attendance, open forums and developing external relationships

• Partner with leading institutions in research (startups, academia, CRO) to collaborate on
concept development and new technology adoption

• Communicates with internal stakeholders to understand clinical trial needs and areas of opportunities

• Lead collaborations with internal stakeholders and vendors to strategize effective innovative solutions

• Provide input into protocol development as it relates to sensors or other clinical technologies

• Create business cases, develop hypothesis, plan pilot and concept testing, execute surveys to progress innovative strategies at a trial, program or corprorate level

• Develop global best practices to support adoption of different innovation technologies

• Set qualification requirements for new vendors supporting innovations

• Use interpersonal, negotiating, and project management skills to drive end to end project development and manage risk as related to new services technologies.

• Support and monitor financial components related to Innovation for each study

• Collaborate with key internal stakeholders, including statistics and data management on data specifications, standards, and transfers

• Apply problem solving strategies to issues and maintain issue tracking documentation to monitor progress and ensure timely resolution to escalations

• Communicate clinical innovations in eSource modalities to stakeholders 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

Requirements:

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 technolgoies

• 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 executing

• Effective communication skills (verbal, written and presentation abilities)

• Ability to independently perform and manage multiple tasks at one time and meet deadlines in a complex 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

Key Team Membership (including, but not limited to):

• Clinical Study Team

• Clinical Operations Review Meeting(s)

• Clinical Compliance Meeting(s)

Cross Functional Interfaces (including, but not limited to):

• COA Manager

• Clinical Study Lead, Program Operations Leader

• Medical Director(s)

• Health Economics & Outcomes Research

• Project Management

• Data Management, Biostatistics

• Procurement

• Clinical Finance

Masters degree and minimum of 8 years relevant industry experience.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.