Director Medical Operations, Externally Sponsored Research Collaborations
Regeneron Pharmaceuticals, Inc, Sleepy Hollow Trailer Village, Arizona, United States
Role Overview
The Director, Medical Operations, will manage our Externally Sponsored Research (ESR) Collaboration program. 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.
This position is at our Sleepy Hollow, NY office and will require you to be on‑site 4 days/week. We cannot offer a remote work option. If eligible, we can offer relocation benefits.
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, and 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:
Support medical focused Externally Sponsored Research, Investigator Initiated Studies and/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.
Qualifications
A bachelor’s degree is required along with 11+ years active work experience in area of clinical research, regulatory or field‑based function in the pharmaceutical industry.
Experience in Medical Study Operations is required.
Experience leading a team of 2+ 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 culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on‑site policy and expectations for your role and your location.
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.
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) $183,100.00 - $305,200.00
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This position is at our Sleepy Hollow, NY office and will require you to be on‑site 4 days/week. We cannot offer a remote work option. If eligible, we can offer relocation benefits.
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, and 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:
Support medical focused Externally Sponsored Research, Investigator Initiated Studies and/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.
Qualifications
A bachelor’s degree is required along with 11+ years active work experience in area of clinical research, regulatory or field‑based function in the pharmaceutical industry.
Experience in Medical Study Operations is required.
Experience leading a team of 2+ 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 culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on‑site policy and expectations for your role and your location.
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.
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) $183,100.00 - $305,200.00
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