Lead the development, assessment, and alignment of site activation projections, ensuring cross-functional and CRO collaboration to meet strategic objectives.
Ensure comprehensive and compliant documentation of site start-up materials in the Trial Master File (TMF) to maintain inspection readiness.
Country Start-Up
Partner with cross-functional and CRO partners (where applicable) to develop a comprehensive global country start-up strategy, outlining all dependencies impacting country start-up while actively mitigating and escalating risks cross-functionally.
Monitor and maintain country intelligence data to support informed decision-making and develop accurate start-up projections and strategic plans.
Support regulatory submissions as needed, including
Providing required site documentation
Coordinating submissions to Central Institutional Review Boards (CIRBs)
Supporting sites with Local Institutional Review Board (LIRB) submissions
Handling or supervising Clinical Research Organization (CRO) insurance requests
Ensure timely country submission deliverables (task completion, role clarity, identification of critical path items, and effective communication pathways).
Site Start-Up Management
Lead and oversee all aspects of site start-up activities, including fast-track site initiation, site calls, document collection, and milestone tracking, ensuring timely and efficient completion of processes.
Serve as the subject matter expert for essential site documents, providing training, guidance, and support to teams and sites on regulatory requirements, document management, and TMF filing.
Oversee CRO site start-up management or the in-house site-facing regional SSU team, where applicable.
Lead the collection and analysis of site intelligence to support strategic site selection and site start-up.
Oversee the preparation and approval of site regulatory packages, ensuring compliance with country-specific requirements, TMF standards, and ICH-GCP guidelines, while supporting inspection readiness and maintaining high-quality site documentation.
Team Interactions
Represent Site Start-Up (SSU) on cross-functional teams, providing updates, escalating challenges, and proposing mitigation strategies for site start-up issues.
Act as the escalation point for CRO and internal teams to ensure timely SSU issue resolution.
Process Improvement
Recommend and participate in cross-functional and departmental process improvements.
Travel
May require up to 25% travel
This role requires
Demonstrated interpersonal & leadership skills
Ability to understand and implement the operational strategic direction and guidance for respective clinical studies
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
Ability to influence and negotiate across key stakeholders
Ability to build productive study teams collaborations
Experience in the clinical drug development process, with expertise in study start-up
Demonstrated vendor management experience
Technical proficiency in trial management systems (CTMS, TMF) and MS applications including (but not limited to) Project, PowerPoint, Word, Excel
Knowledge of ICH/GCP and regulatory guidelines/directives
Effective project management skills, cross-functional team interaction and organizational skills
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
- Salary Range (annually)
- $114,800.00 - $187,400.00
