Director, Clinical Outcomes Assessment & Innovations

Jul 17, 2017
Jul 19, 2017
Employer Type
Direct Employer
Employment 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.

The Clinical Outcomes Assessment (COA) & Innovations Lead will provide leadership and strategic vision in the definition, implementation, and management of COA (e.g., electronic PRO (ePRO) and electronic COA (eCOA)) across Global Development. The role manages utilization of technologies and strategies to advance Regenerons product portfolio. The role is a cross-functional liaison to increase awareness amongst other stakeholders for Regeneron-specific needs and requirements as it relates to COA and data integration (e.g., data management, IVR). Provides oversight for individual clinical research studies for eCOA in collaboration with the study team. Functions as Subject Matter Expert (SME) advising internal clinical study teams on best practices in eCOA design to ensure regulatory compliance and data quality. The role is directly responsible for management of eCOA vendors, vendor performance, and strategy. The Clinical Outcomes Assessment & Innovations Lead may develop strategy & processes for expansion of eSource modalities to enable data availability in a virtual clinical trial environment. Develops a vision for innovative clinical trial data capture and integration. This role may be responsible for line management of staff including recruitment, retention, professional development, training, mentoring, and performance management.

  • Responsible & accountable for the successful delivery of eCOA for applicable clinical research trials with quality and compliance
  • Responsible for standard operating procedure development, maintenance and continuous improvement
  • Responsible for reviewing and approving project related eCOA study documentation during the course of the Project Lifecycle
  • Lead the Planning and Setup, Monitoring, and Closeout phases of eCOA which include:
o Collaborating with study teams for RFP process at the trial level as it relates to eCOA
o Gathering customer requirements and relaying to vendor(s)
o Reviewing study documentation and statement of work from vendor(s)
o Reviewing vendor reports
o Developing UAT test scripts
o Collaborating with data management on data specifications and standards
o Collaborating with clinical sciences and clinical trial management on medical monitoring plan
o Archiving study data and documentation
o Appropriately setting expectations with vendor & ensuring timely receipt of clinical study data
  • Monitor eCOA study timelines and manage the financial components of each study
  • Identify potential study risks and mitigations, and escalate to the Clinical Study Lead
Apply problem solving strategies to issues and maintain issue tracking documentation to monitor progress and ensure timely resolution to escalations
  • Responsible for vendor relationship management including:

o vendor selection and maintenance
o participation in vendor governance/oversight meetings
o review/negotiation/standardization of vendor contracts and budgets with procurement
o establish vendor performance and metrics review
o delivery of standard vendor/sponsor expectations and operations process
o acts as point of contact for trial-specific and vendor related escalations and ensures preventative action implementation
  • Line of site to key industry forums such as CDISC, HL7, CTTI, and TransCelerate
  • Develop strategy & processes for expansion of eSource modalities to enable data availability in a virtual clinical trial environment
  • Communicates clinical innovations in eSource modalities to stakeholders and broader organization
  • Develops strategy for implementation of innovative clinical trial technologies and disruptive innovations
  • Provide consultation on PRO modality benefits, risks, costs and process
  • Initiates and participates in strategic projects and initiatives within Global Development
  • Fosters and promotes best practices across clinical study teams and contributes to lessons learned
  • Direct line management responsibilities of all staff (as applicable) which may include: work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance
  • Advanced degree preferred and minimum of 10 years relevant industry experience.
  • Experience in the development and/or delivery of patient reported outcomes tools and services, development of eClinical systems and services
  • Knowledge of PRO, COA, and eCOA techniques and methodologies
  • Good understanding of the overall clinical development process and solid experience in new technologies
  • Experience in eClinical Product Management
  • Training in system development lifecycle methodology and other disciplines relevant to eCOA system design
  • Ability to provide strategic direction and guidance to teams with respect to eCOA
  • Ability to anticipate and react to new trends & technologies
  • Strong interpersonal & leadership skills
  • Effective communication skills to all levels of the organization
  • Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
  • Accomplished influencing and negotiation skills
  • Strong financial acumen
  • Demonstrated vendor management experience
  • Line management experience with demonstrated mentoring and coaching skills
  • In depth knowledge of GCP and ICH, and regulations related to electronic data sources
Key Team Membership:
  • Vendor Governance Committee(s)
  • Clinical Operations Review Meeting(s)
  • Development Team(s)
  • Clinical Study Team(s)
  • Clinical Compliance Meeting(s)
  • Strategy Review Meeting(s)
Cross Functional Interfaces
  • Interface with key clinical and regulatory functional area leads
  • Project Management
  • Medical Director(s)
  • Clinical Trial Management
  • Data Management
  • Procurement
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 Regenerons 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.