Associate Director, Clinical Outcomes Assessment

As the Associate Director, Clinical Outcome Assessment, a typical day might include:

Responsible for leadership and overall strategic management of one or more COA programs of limited scope and complexity in Clinical Trial Management (CTM). This individual is responsible for COA operations activities and decisions including COA instrument selection, validation, debriefing, translation, vendor oversight, quality, timelines, and budgets related to the conduct of COA studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned program(s). 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 COA data integration (e.g., data management, IVR).  Provides oversight at program level and individual clinical research studies for eCOA in collaboration with the study team.  Functions as Subject Matter Expert 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 and vendor performance at program level. The COA PL is responsible for line management , including responsibility for staff recruitment, development, coaching, mentoring and performance management.

This role might be for you if:

• Responsible & accountable for the successful delivery of eCOA for applicable clinical research trials with quality and compliance within one or more programs

• Execute COA development process from study design, execution, change control management and database lock activities, as needed

• Responsible for the overall success of the COA development and strategy within a program(s)

• Maintains an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or changes that may impact quality, timelines and/or budget; provide  COA clinical program level updates to stakeholders as requested

• Provides operational insight into COA selection, vendor, timeline and cost estimates during clinical program/study development

• Oversees COA timelines within a clinical program(s)

• Lead the Program Planning and Setup phases of eCOA which include:

  • Guiding COA selection through team collaboration and literature review

  • Providing support to Health Economics Outcomes Research (HEOR) for instrument development

  • Oversee cognitive debriefing, and psychcometric validation studies

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

• May be responsible for vendor relationship management including:

  • vendor selection and maintenance

  • participation in vendor governance/oversight meetings

  • review/negotiation/standardization of vendor contracts and budgets with procurement

  • establish vendor performance and metrics review

  • delivery of standard vendor/sponsor expectations and operations process

  • acts as point of contact for trial-specific and vendor related escalations and ensures preventative action implementation

• Provides input during protocol development and ensures consistency across the program

• Drives decision making and integrates all COA operational considerations for studies within a clinical program(s) to ensure goals are attainable prior to implementation

• Acts as point of contact for COA at program and study level escalation

• Reviews key metrics and Key Performance Indicators across studies within assigned program(s) to track study progress and vendor performance

• Provides proactive creation and implementation of risk mitigation strategies

• Provides innovative and flexible COA solutions and options to the cross functional and development teams; assists in preparing scenarios for creative solutions to challenges

• Identifies and recommends changes to practices and policies, including initiating and participating in strategic projects, initiatives, and continuous improvement projects within Global Development

• Participates in eCOA and translation vendor governance meetings as needed for clinical program(s)

• Ensures inspection readiness throughout the clinical program lifecycle

• Responsible for COA resource forecasting and resource allocation for clinical studies across one or more clinical programs

• Responsible for direct supervision of COA staff.  Line management responsibilities include: work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight.

• 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 eligible 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 parental 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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