The Director Global Study Start-Up will be responsible for the concept, design, growth and deliverables of the integrated Study Start-Up team, assuring the highest quality support for delivery of development programs on time and on budget. This person requires an entrepreneurial approach, strong analytical abilities, relationship management skills, creative thinker, problem solver, and experience with clinical trial process. The Director will develop and implement an effective organizational structure, processes/ procedures and systems that enable rapid study start-up process across the Regeneron portfolio. We believe the Director is tasked with the management and oversight of study start up activities for the portfolio of studies as well as oversight and management of multiple vendors who supply systems, services, and functional support.
This role requires a minimum of 3-days onsite and is not eligible fully remote.
A typical day in this role looks like:
- Responsible and accountable for developing and overseeing the organization, strategies and processes related to Study Start-Up ensuring the successful and on-time delivery of study start-up tasks and coordination including sourcing strategy and internal infrastructure management
- Lead and develop strategy for the development of a study start-up team
- Provide leadership and oversight for functional group deliverables, management, and team/staff development
- Provide leadership for CRO and study teams in driving study start-up activities; set functional deliverable targets and provide oversight for vendors
- Oversee functional strategies for managing external engagements in collaboration with other Regeneron groups (i.e. patient, site, vendor and collaborations)
This role may be for you if you have:
- Strong understanding and experience in operationalizing clinical development programs in a global setting from first-in-human to post-approval
- Compelling communicator with ability to translate complex messages to a variety of audiences.
- Proven ability to build strong working relationships in a diverse range of team environments, including Vendor & Relationship Management, Clinical Study Contracts & Budgets, Regulatory/Ethics committee/IRB interactions, Clinical Drug Supply and Logistics, and Regulatory Compliance
- Experience in applying data to inform clinical strategy development
To be considered for the role, we are looking for individuals to have at least 11 years of experience within the clinical trial management with a focus on Study Start Up.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
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.
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.-based 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. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. 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)
$180,400.00 - $300,700.00
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