Manager, Medical Study Operations

Tarrytown, NY, United States
Mar 21, 2021
Required Education
Position Type
Full time
As a Manager, Medical Study Operations you will be responsible for all operational aspects of projects/programs such as our Compassionate Use Programs, Investigator-Initiated (IIS) Studies Program, Collaboration Studies, Expanded Access Programs, Pre-Clinical Collaborations and Sample Analysis Studies. Based on team assigned, this role may include supervision of staff.

A typical day may include the following:
Program management activities: Operational responsibility across our multiple projects/program(s) with minimal direction. 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 Medical Study Operations for our studies within span of responsibility. Maintenance of program budget trackers for each molecule/activity, ensuring all communicated actuals and accruals are captured, projections are reforecaseted as necessary, and brand give back are fully assessed.

Drug Supply: Responsible for managing drug supply for Compassionate Use and IIS programs, 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.
Systems Management: Utilizes appropriate systems to contribute to cross-functional communication, planning and transparency.

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.

Aligning 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 raise issues and involve senior levels of management to obtain adequate resolution.

Alliance Management: Ensures financial transparency and alignment with both Alliance and internal partners, supporting the product team financial reviews.

This may be for you if you:
Are passionate about the impact your work can have on the healthcare community
Enjoy a work environment with cross-functional teams.
Are at ease with an abundance of detail and complexity, yet mindful of the big picture.
Have the innate ability to balance multiple projects and initiatives, prioritize them and execute them independently, while excelling at keeping all partners advised and engaged

To be considered, you need to have a minimum of Bachelor's Degree (advanced science degree is preferred). We are seeking 8 + years experience working in research, regulatory or a field-based function fro a pharmaceutical or biotech company. Active working experience and/or courses pertaining to clinical research or Medical Affairs areas (such as GCP, Investigator Initiated Studies; medical/educational grants administration; medical information; registries; OIG/PhRMA guidance.) is required. You must be self-motivated, able to work with a limited amount of supervision after the initial on-boarding period and enjoy working with different partners (clinical, pre-clinical, commercial, external customers).
  • Preferred experiences would include: science background with active experience in therapeutic areas of inflammation/immunology/antibody research.

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 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 maternity 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.