Temp Global Site Start Up Lead

Build our future together:
Within Regeneron, there are a growing number of diverse collaborations and alliances with external entities. This individual will help to build productive external partnerships across several key areas. The Director will support the identification, execution and management of overarching strategic relationships with various organizations and institutions to support the Global Clinical Development organization’s efforts to more effectively develop Regeneron's product candidates and advance the company’s broader R&D objectives.

The individual will function as a strategic and critical thinker, identifying and developing key external relationships and coordinating across a matrix of teams with the purposes of finding opportunities and streamlining external partnership initiation and maintenance. They will be focused on further building an internal capability on behalf of Regeneron that is highly-regarded by external partners and internal leaders. The individual will partner closely with other internal leaders embedded in the company who work with external partners to ensure collaboration, continuity and alignment.

This role will be highly collaborative with other functions and will require thoughtful and inclusive leadership. This role will be tasked with not only identifying strategic partnerships, but facilitating the drafting and execution of contracts, as well as remaining connected to the overarching relationships, while helping to facilitate the components that live in specific areas throughout the life of the agreements.

Location:

Armonk, or Warren
Work model/flexibility: in office 3-4 days per week
May require up to 25% travel

The Manager, Global Site Start‑Up Lead (SSU Lead) is responsible for driving the global execution of site activation for clinical trials, performing the role with moderate oversight to ensure efficient and compliant processes aligned with Regeneron SOPs, ICH‑GCP guidelines, and industry standards. Partnering closely with cross‑functional teams and Clinical Research Organizations (CROs), this role balances strategic oversight with hands‑on leadership to address challenges and deliver study objectives.

The SSU Lead develops site activation projections, mitigates risks impacting site activation, and monitors CRO performance by analyzing metrics. Additionally, they lead all aspects of site start‑up activities, including fast‑track initiation, milestone tracking, and document collection, while ensuring timely submissions and leveraging country intelligence for informed decision‑making.

Develop the site start‑up strategy for each study, 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…