BioSpace
Director Medical Study Operations
BioSpace, Sleepy Hollow Trailer Village, Arizona, United States
Job Overview
Director, Medical Study Operations responsible for External Sponsored Research programs including Investigator‑Initiated Studies and Research Collaboration. Manage people, structure, procedures, deliverables, and financial management for these programs.
Typical Responsibilities
Support Investigational and Commercialized Products; manage timelines, key deliverables, budgets, forecasting, disclosures, and compliance.
Support Late‑Stage Molecules and launch‑readiness activities.
Support Early‑Phase molecules post‑IND filing; review non‑clinical/non‑drug studies to ensure alignment with brand and corporate strategy.
Alliance Management: Align external collaborators and internal teams for therapeutic areas; drive activities forward, communicate risks and solutions.
Ensure ESR programs are compliant; complete cross‑functional reviews and secure senior input as needed.
Program Management: oversee budgets, timelines, publications, risk management, and compliance. Manage lifecycle planning, budget allocation, risk strategy, and annual review of areas of interest.
Budget Tracking, Planning, Reporting: oversee budgeting aspects, including projections, actuals, reforecasts, and audit reporting.
Drug/Material Planning, Shipping, Tracking, Expiry, Temperature Excursions, and Quarantines: ensure compliance for shipments and related processes.
Compliance: Maintain ESR processes, FMV, safety, regulatory, and training adherence; update SOPs, working practices, and tracking documents.
Recruit, develop, and mentor direct reports; set growth‑oriented goals and development plans.
Required Qualifications
Bachelor’s degree or advanced degree, or equivalent work experience.
16+ years of progressive industry experience; 11+ years in clinical research, regulatory, or field‑based function within pharmaceutical/biotech companies, including relevant coursework.
Demonstrated foresight, communication, critical thinking, regulatory adaptability, leadership, and compliance across a department.
Salary Range $180,400.00 - $300,700.00 annually.
Company Information 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, nationality 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.
Additional Information Certain background checks will form part of the recruitment process and will be conducted in accordance with the law of the country where the position is based.
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Typical Responsibilities
Support Investigational and Commercialized Products; manage timelines, key deliverables, budgets, forecasting, disclosures, and compliance.
Support Late‑Stage Molecules and launch‑readiness activities.
Support Early‑Phase molecules post‑IND filing; review non‑clinical/non‑drug studies to ensure alignment with brand and corporate strategy.
Alliance Management: Align external collaborators and internal teams for therapeutic areas; drive activities forward, communicate risks and solutions.
Ensure ESR programs are compliant; complete cross‑functional reviews and secure senior input as needed.
Program Management: oversee budgets, timelines, publications, risk management, and compliance. Manage lifecycle planning, budget allocation, risk strategy, and annual review of areas of interest.
Budget Tracking, Planning, Reporting: oversee budgeting aspects, including projections, actuals, reforecasts, and audit reporting.
Drug/Material Planning, Shipping, Tracking, Expiry, Temperature Excursions, and Quarantines: ensure compliance for shipments and related processes.
Compliance: Maintain ESR processes, FMV, safety, regulatory, and training adherence; update SOPs, working practices, and tracking documents.
Recruit, develop, and mentor direct reports; set growth‑oriented goals and development plans.
Required Qualifications
Bachelor’s degree or advanced degree, or equivalent work experience.
16+ years of progressive industry experience; 11+ years in clinical research, regulatory, or field‑based function within pharmaceutical/biotech companies, including relevant coursework.
Demonstrated foresight, communication, critical thinking, regulatory adaptability, leadership, and compliance across a department.
Salary Range $180,400.00 - $300,700.00 annually.
Company Information 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, nationality 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.
Additional Information Certain background checks will form part of the recruitment process and will be conducted in accordance with the law of the country where the position is based.
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