Temp Global Site Start Up Lead

Regeneron Pharmaceuticals, Inc (USA); Kentucky; Hybrid; USD 180,000 - 240,000; Full time

Benefits offered by this job

Annual bonus

Equity awards

Pension

401(k) match

Health & wellness programs

Fitness centers

Insurance benefits

Paid time off

Family support benefits

Job summary

Regeneron Pharmaceuticals, Inc (USA) in Armonk or Warren seeks a Manager, Global Site Start-Up Lead to drive the global execution of site activation for clinical trials. You will balance strategic oversight with hands-on leadership, partnering with CROs and cross-functional teams to meet study objectives.

You will develop start-up projections, mitigate risks, and ensure timely site regulatory packages and TMF readiness while enabling efficient collaboration across functions and regions.

Qualifications

• Experience leading global site start-up for clinical trials.
• Ability to coordinate cross-functional teams and CROs.
• Knowledge of ICH-GCP, TMF, and regulatory submissions.

Responsibilities

• Lead site start-up strategy and projections across studies.
• Oversee country start-up, regulatory submissions, and CRO performance.
• Manage fast-track initiation, milestone tracking, and TMF delivery.
• Mentor teams on regulatory requirements and document management.

Skills

Strategic leadership

Cross-functional collaboration

Project management

Risk assessment

Regulatory knowledge

Job description

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.

When & where:

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

Discover your role:

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.

Site Start‑up Strategy

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.

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 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).

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 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.

Team Interactions

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.

Process Improvement

Recommends and participates in cross functional and department process improvements.

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
• 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.

Regeneron is a leading biotechnology company that invents life‑transforming medicines for people with serious diseases. Founded and led for over 30 years by physician‑scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA‑approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.