Regeneron · 2 days ago
Senior Manager Global Site Start-Up Lead
Warren, NJ
Full-time
Onsite
Senior Level, Lead/Staff
$134K/yr - $219K/yr
8+ years expRegeneron is a leading biotechnology company, and they are seeking a Senior Manager Global Site Start-Up Lead to drive the global execution of site activation for complex clinical trials. This role involves strategic oversight and hands-on leadership to ensure efficient and compliant processes while managing cross-functional teams and CROs.
BiopharmaBiotechnologyPharmaceutical
Responsibilities
Develop the site start up strategy for each study assigned (complex, high profile), outlining all dependencies impacting site activation and actively mitigating and escalating risks
Oversee the tracking and analysis of study metrics, including risks and mitigation strategies and to evaluate CRO performance and implement corrective actions
Advocate for optimized site selection strategies, leveraging data-driven insights to guide cross-functional teams toward effective decision-making
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
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 and actively mitigating and escalating risks cross functionally
Monitor and maintain country intelligence data to support informed decision-making and develop accurate startup projections and strategic plans
Support regulatory submissions as needed, including activities such as: providing required site documentation, coordinating submissions to Central Institutional Review Boards (CIRBs), supporting sites with Local Institutional Review Board (LIRB) submissions, and handling or supervising Clinical Research Organization (CRO) insurance requests, etc
Ensure timely country submission deliverables (ensure task completion; all roles clarity, identification of critical path items, effective communication pathway)
Lead and oversee all aspects of site start-up activities for complex, high profile studies, 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 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 package, ensuring compliance with country-specific requirements, TMF standards, and ICH-GCP guidelines, while supporting inspection readiness and maintaining high-quality site documentation
Represent 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 team to ensure timely SSU issue resolution
Recommends and drives cross functional and department process improvements
Responsible for direct supervision of SSU staff. Line management responsibilities include work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight
Qualification
Required
A minimum of a Bachelor's degree
8+ years of relevant industry experience
Strong interpersonal and leadership skills
Ability to provide and implement operational strategic direction and guidance for respective clinical trials
Demonstrates strong knowledge and a data driven approach to planning, executing, and problem solving
Strong 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
Ability to lead and develop productive study teams and collaborations
Applies advanced negotiation and interpersonal skills to vendor management
Strong technical proficiency in trial management systems (CTMS, TMF) and MS applications including (but not limited to) Project, PowerPoint, Word, Excel
Extensive experience in the clinical drug development process, including study start-up
Knowledge and understanding of ICH/GCP and regulatory guidelines/directives
Strong project management skills, cross-functional team interaction and organizational skills
Preferred
Line management experience preferred
Preference in a sponsor Site Start-Up role preferred
Benefits
Health and wellness programs (including medical, dental, vision, life, and disability insurance)
Fitness centers
401(k) company match
Family support benefits
Equity awards
Annual bonuses
Paid time off
Paid leaves (e.g., military and parental leave)
Company
Regeneron
Regeneron Pharmaceuticals specializes in the discovery, development, and commercialization of innovative medicines.
10001+ employees
H1B Sponsorship
Regeneron has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (157)
2024 (128)
2023 (128)
2022 (137)
2021 (104)
2020 (122)
Funding
Current Stage
Public CompanyTotal Funding
$15.93MKey Investors
U.S. Department of Health & Human Services
2024-07-11Post Ipo Equity· $2.03M
2023-10-18Post Ipo Equity· $5M
2016-08-22Post Ipo Equity· $8.9M
Leadership Team
Aris Baras
Senior Vice President, Regeneron Pharmaceuticals, General Manager, Regeneron Genetics Center
Bari Kowal
Senior Vice President, Head Development Operations & Portfolio Management
Recent News
Pharmaceutical Technology
2026-01-16
2026-01-16
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