Senior Manager, Medical Operations

Regeneron Pharmaceuticals • Sleepy Hollow, WY

8d

About The Position

The Senior Manager, Managed Access Programs will be responsible for all operational aspects of multiple projects/programs such as Expanded Access Programs, individual patient expanded access, and post-trial access managed by Medical Affairs. Based on team assigned, this role may include supervision of staff. Additionally, the incumbent will support other MA projects, as requested. As a Senior Manager, a typical day may include: Program management activities: Has operational responsibility across multiple projects/program(s) with minimal direction: Expanded Access Programs, individual patient expanded access, post-trial access Meetings & Committees: Participates in team review meetings, product team alignment meetings, and program budget & status update meetings as needed Budget Management: Accountable for financial forecasting accuracy of Managed Access Programs within span of responsibility Maintenance of program budget trackers for each molecule/activity, ensuring all communicated actuals and accruals are captured, projections are reforested as necessary, and brand give back are fully assessed Maintains financial forecast for programs for quarterly for reporting to Accounting & Finance, and responsible for ensuring issue resolution for all discrepancies Drug Supply: Responsible for managing drug supply for Expanded Access Programs and individual patient expanded access, as appropriate Metrics & Reporting: Responsible for ongoing analyses, tracking and reporting of projects/programs support, timelines for completion, expected or assessed delays, solutions for streamlining processes for greater efficiency, and other related metrics in support of program activities Vendor Management: Manages vendors and financial tracking as required per program Essential Documents: Ensures appropriate archiving of projects’/programs’ essential documents Systems Management: Utilizes appropriate systems to contribute to cross-functional communication, planning and transparency, including but not limited to: Ensures ongoing QC of SharePoint document storage for completeness and audit readiness Expertise required in the utilization of QlikSense, QlikView, SharePoint, Oracle and ESRA portal to support team needs Process: Adheres to all relevant processes, trainings, and SOPS to ensure consistency, efficiency, and compliance. Exercises' judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions; Continued process improvements Organizational goals: Development of objectives in order to quantify success and attainment of goals. Ensures optimal structure, procedures, and adequate resources supporting growth of multiple projects/programs. Knows when to escalate issues, and involve senior levels of management to obtain adequate resolution Alliance Management: Ensures financial transparency and alignment with both Alliance and internal stakeholders, supporting the product team financial reviews

Requirements

• To be considered a bachelor’s degree is required and an advanced degree preferred.
• 5- 8 years’ experience working in clinical research or medical operations within the pharmaceutical or biotech industry.
• Active working experience and/or courses pertaining to clinical research and/or MA areas (such as GCP, Investigator Initiated Studies; medical/educational grants administration; medical information; registries; OIG/PhRMA guidance.).
• Strong communication and presentation skills for senior management audiences.

Nice To Haves

• Compassionate Use or Managed Access programs preferred.

Responsibilities

• Has operational responsibility across multiple projects/program(s) with minimal direction: Expanded Access Programs, individual patient expanded access, post-trial access
• Participates in team review meetings, product team alignment meetings, and program budget & status update meetings as needed
• Accountable for financial forecasting accuracy of Managed Access Programs within span of responsibility
• Maintenance of program budget trackers for each molecule/activity, ensuring all communicated actuals and accruals are captured, projections are reforested as necessary, and brand give back are fully assessed
• Maintains financial forecast for programs for quarterly for reporting to Accounting & Finance, and responsible for ensuring issue resolution for all discrepancies
• Responsible for managing drug supply for Expanded Access Programs and individual patient expanded access, as appropriate
• Responsible for ongoing analyses, tracking and reporting of projects/programs support, timelines for completion, expected or assessed delays, solutions for streamlining processes for greater efficiency, and other related metrics in support of program activities
• Manages vendors and financial tracking as required per program
• Ensures appropriate archiving of projects’/programs’ essential documents
• Utilizes appropriate systems to contribute to cross-functional communication, planning and transparency, including but not limited to: Ensures ongoing QC of SharePoint document storage for completeness and audit readiness Expertise required in the utilization of QlikSense, QlikView, SharePoint, Oracle and ESRA portal to support team needs
• Adheres to all relevant processes, trainings, and SOPS to ensure consistency, efficiency, and compliance.
• Development of objectives in order to quantify success and attainment of goals.
• Ensures optimal structure, procedures, and adequate resources supporting growth of multiple projects/programs.
• Ensures financial transparency and alignment with both Alliance and internal stakeholders, supporting the product team financial reviews

Benefits

• health and wellness programs (including medical, dental, vision, life, and disability insurance)
• fitness centers
• 401(k) company match
• family support benefits
• equity awards
• annual bonuses
• paid time off
• paid leaves (e.g., military and parental leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees