Job Description:
As a seasoned Clinical Study Lead, you will be responsible for overseeing the global execution of assigned clinical trials from study design through to study close out. Your primary goal will be to ensure that all studies are conducted in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP guidelines.
You will lead cross-functional study teams, provide operational input into protocol development, and oversee the setup and maintenance of study systems. Additionally, you will be responsible for ensuring compliance with clinical trial registry requirements, identifying outsourcing needs, and leading vendor management efforts.
Key responsibilities include:
* Leading cross-functional study teams
* Providing operational input into protocol development
* Overseeing the setup and maintenance of study systems
* Ensuring compliance with clinical trial registry requirements
* Identifying outsourcing needs and leading vendor management efforts
Required Skills and Qualifications:
To be successful in this role, you will need to possess:
* Demonstrated interpersonal & leadership skills
* A data-driven approach to planning, executing, and problem-solving
* Effective communication skills via verbal, written, and presentation abilities
* Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
* Budget management experience
* An awareness of relevant industry trends
* Ability to build productive study teams and collaborations
* Demonstrated vendor management experience
* Technical proficiency in trial management systems and MS applications
* Experience in global clinical trial operations
* Knowledge of ICH/GCP and regulatory guidelines/directives
* Effective project management skills, cross-functional team leadership, and organizational skills
Benefits:
We offer a comprehensive benefits package that includes:
* Comprehensive health and wellness programs
* Fitness centers
* Equity awards
* Annual bonuses
* Paid time off for eligible employees at all levels
Others:
Regeneron is an equal opportunity employer and welcomes applications from qualified individuals without regard to race, color, religion or belief, 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.
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. 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.