Job Description
Senior Clinical Study Lead
Regeneron is seeking a highly experienced Senior Clinical Study Lead to oversee the global execution of large and complex clinical trials from study design through execution to study close-out.
- Accountable for study timelines, budget, and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP.
- Leads cross-functional study teams and is the primary point of contact for leadership and oversight for assigned studies.
- Provides operational input into protocol development and oversees the development of study-specific documentation.
- Ensures compliance with clinical trial registry requirements and identifies outsourcing needs of the study.
- Leads risk assessment and identifies risk mitigation strategies at the study level.
- Monitors progress for site activation and monitoring visits and acts on any deviations from plan.
- Ensures accurate budget management and scope changes for internal and external studies.
- Oversees data quality and ensures the CROs and Third Party Vendors are in alignment and are delivering per the scope of work.
- Ensures clinical project audit and inspection readiness through the study lifecycle.
- Manages and oversees study close-out activities.
Key qualifications include:
- Exceptional interpersonal and leadership skills.
- Advanced expertise and implements the operational strategic direction and guidance for respective clinical studies.
- Demonstrates expert knowledge and a data-driven approach to planning, executing, and problem-solving.
- Advanced communication skills via verbal, written, and presentation abilities.
- Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization.
- Ability to influence and negotiate across a wide range of stakeholders.
- Strong budget management experience.
- An awareness of relevant industry trends.
- Ability to build, lead, and develop productive study teams and collaborations.
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.