The Director, Medical Study Operations will oversee several of our External Sponsored Research (ESR) programs inclusive of Investigator-Initiated Studies (IIS) and Research Collaboration (RC). Responsibilities will also include people management, maintaining appropriate structure and procedures to support our growth. Additionally, you will ensure timely deliverables and financial management support.

A typical day may include the following: 
Support of Investigational and/or Commercialized Products, including non-filing post-marketing research activities, timelines, results, budgets, forecasting, disclosures, and compliance.
Support of Late-Stage Molecules, and launch readiness activities. 
Support of Early Phases molecules, post-IND filing, ensure non-clinical and non-drug studies are reviewed in line with our strategy. 
Develop a team ensuring growth minded goals, and development plans.
Ensuring efficient alignment with both Alliance and internal partners. 
Ensure External Sponsored Research (ESR) programs are led compliantly. 
Program planning, allocation and movement of program budgets, timelines and program results, risk strategy/mitigation planning, and ensuring annual review of Areas of Interest. 
Supervise all budgeting aspects including annual planning, initial projections for upcoming activities/programs, drug related costs, reforecasts, actuals, and accrual information. 
Coordinate appropriate drug/material planning including timing of drug and labeling campaigns, expiry events and potential impact, and ensuring compliance for shipments, temp excursions, and quarantines.
Compliance: ESR Processes, FMV, Safety, Regulatory, Training. 
Adheres to and ensures team adherence to all applicable SOPs, working guidance, workflows, required reporting, maintaining support of programs. Create/update relevant SOPs, working practices, forms and tracking documents as needed, ensuring audit readiness

This may be for you if you: 
•    Have supported IIS, medical focused Externally Sponsored Research or Research Collaborations. 
•    Want to have an impact on patient lives
•    Can demonstrate a track record of being successful in fast-paced, dynamic environment. 
•    Enjoy influencing management both internally and externally.

To be considered, a Bachelor's degree is required along with 11+ years active work experience in area of clinical research, regulatory or field-based function in pharmaceutical industry. Experience in Medical Study Operations is required. Experience leading a team of 5+ ensuring goals are achieved. Ability to redirect and create solutions for new regulations or anticipation of updated regulations. A science background ideally in the therapeutic areas of oncology is preferred. 
 

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible 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 parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions.  For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process.  Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)