Senior Manager, Medical Operations, 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.

As a Senior Manager, a typical day may include:

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.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

 

Where necessary, we disclose salary ranges for roles in all countries in which we operate.  The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or 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. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.  If you have any questions, please speak with your recruiter. 

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$134,400.00 - $219,200.00