Senior Manager, Medical Operations, Expanded Access Programs

About the role

The Senior Manager, Expanded Access Programs will oversee operational aspects of various projects/programs such as Expanded Access Programs, individual patient expanded access, and post-trial access managed by Medical Affairs. This role may also include supervising staff.

Responsibilities

• 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
• Maintains 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
• Manages 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. Exercises' judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions; Continued process improvements
• Develops 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

Requirements

• Bachelor's Degree
• 5-8 years of 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)
• Clinical Research or Medical Operations experience preferred
• Compassionate Use or Managed Access programs preferred
• Strong communication and presentation skills for senior management audiences

Qualifications

• Advanced degree preferred

Skills

• Expertise in QlikSense, QlikView, SharePoint, Oracle and ESRA portal
• Financial forecasting and management
• Project management
• Vendor management
• Document archiving
• Communication and presentation skills

Benefits

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits.

Pay

$134,400.00 - $219,200.00 annually

Schedule

Full time