Senior Manager, Medical Operations, Expanded Access Programs

Senior Manager, Expanded Access Programs

The Senior Manager, Expanded 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, this role will support other MA projects, as requested.

Program Management:

• 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

To be considered a bachelor's degree is required and an advanced degree preferred. You are to have 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.). Compassionate Use or Managed Access programs preferred. We are seeking strong communication and presentation skills for senior management audiences.