Director Medical Operations, Externally Sponsored Research Collaborations
Regeneron Pharmaceuticals, Inc, Sleepy Hollow Trailer Village, AZ, United States
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 on-site at our Sleepy Hollow, NY office four days per week; remote work is not offered. If eligible, relocation benefits may be available. Responsibilities
Support Investigational and/or Commercialized Products, including non-filing post-marketing research activities, timelines, results, budgets, forecasting, disclosures, and compliance. Support Late-Stage Molecules and launch readiness activities. Support Early Phases molecules, post-IND filing; ensure non-clinical and non-drug studies are reviewed in line with our strategy. Develop a team with growth-minded goals and development plans. Ensure efficient alignment with Alliance and internal partners. Lead External Sponsored Research (ESR) programs compliantly. Plan programs, allocate and manage budgets, timelines and program results; implement risk strategy and annual review of Areas of Interest. Supervise budgeting aspects including annual planning, projections for upcoming activities, drug-related costs, reforecasts, actuals, and accrual information. Coordinate drug/material planning including timing of drug and labeling campaigns, expiry events and potential impact; ensure compliance for shipments, temperature excursions, and quarantines. Ensure ESR Processes, FMV, Safety, Regulatory, Training compliance. Adhere to and ensure team adherence to SOPs, working guidance, workflows, reporting requirements; create/update SOPs, practices, forms and tracking documents to support audit readiness. Qualifications
Bachelor’s degree required with 11+ years of active work experience in clinical research, regulatory or field-based roles in the pharmaceutical industry. Experience in Medical Study Operations is required. Experience in leading a team of 2+ people with goals achieved. Ability to adapt and create solutions for new or updated regulations; science background preferably in oncology. Experience supporting medical-focused Externally Sponsored Research, Investigator Initiated Studies and/or Research Collaborations is preferred. Location, Schedule and Benefits
This role is on-site in Sleepy Hollow, NY. Relocation benefits may be available as applicable. Regeneron maintains an inclusive culture with comprehensive benefits that vary by location, including health and wellness programs, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves for eligible employees. For more information about Regeneron benefits in the US, visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries, speak with your recruiter about country-specific benefits. Equal Opportunity and Employment Policy
Regeneron is an equal opportunity employer. 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 in 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 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. Salary Range (annually): $183,100.00 – $305,200.00.
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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 on-site at our Sleepy Hollow, NY office four days per week; remote work is not offered. If eligible, relocation benefits may be available. Responsibilities
Support Investigational and/or Commercialized Products, including non-filing post-marketing research activities, timelines, results, budgets, forecasting, disclosures, and compliance. Support Late-Stage Molecules and launch readiness activities. Support Early Phases molecules, post-IND filing; ensure non-clinical and non-drug studies are reviewed in line with our strategy. Develop a team with growth-minded goals and development plans. Ensure efficient alignment with Alliance and internal partners. Lead External Sponsored Research (ESR) programs compliantly. Plan programs, allocate and manage budgets, timelines and program results; implement risk strategy and annual review of Areas of Interest. Supervise budgeting aspects including annual planning, projections for upcoming activities, drug-related costs, reforecasts, actuals, and accrual information. Coordinate drug/material planning including timing of drug and labeling campaigns, expiry events and potential impact; ensure compliance for shipments, temperature excursions, and quarantines. Ensure ESR Processes, FMV, Safety, Regulatory, Training compliance. Adhere to and ensure team adherence to SOPs, working guidance, workflows, reporting requirements; create/update SOPs, practices, forms and tracking documents to support audit readiness. Qualifications
Bachelor’s degree required with 11+ years of active work experience in clinical research, regulatory or field-based roles in the pharmaceutical industry. Experience in Medical Study Operations is required. Experience in leading a team of 2+ people with goals achieved. Ability to adapt and create solutions for new or updated regulations; science background preferably in oncology. Experience supporting medical-focused Externally Sponsored Research, Investigator Initiated Studies and/or Research Collaborations is preferred. Location, Schedule and Benefits
This role is on-site in Sleepy Hollow, NY. Relocation benefits may be available as applicable. Regeneron maintains an inclusive culture with comprehensive benefits that vary by location, including health and wellness programs, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves for eligible employees. For more information about Regeneron benefits in the US, visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries, speak with your recruiter about country-specific benefits. Equal Opportunity and Employment Policy
Regeneron is an equal opportunity employer. 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 in 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 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. Salary Range (annually): $183,100.00 – $305,200.00.
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