Regeneron Pharmaceuticals, Inc

Manager, Global Site Start-Up Lead

Regeneron Pharmaceuticals, Inc • $114K — $187K *
Warren, MI 48089In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
2 weeks ago
Job Overview by Ladders

Qualifications

  • Bachelor's degree with 6+ years relevant experience
  • Strong interpersonal and leadership skills
  • Thorough understanding of strategic operational direction for clinical studies
  • Data-driven approach to planning and problem solving
  • Excellent verbal and written communication skills
  • Proactive, disciplined with time management and prioritization
  • Ability to build collaborations and influence stakeholders
  • Experience in clinical drug development with focus on study start-up
  • Proficient in trial management systems and MS applications
  • Knowledge of ICH/GCP and regulatory guidelines
  • Strong project management and organizational skills

Responsibilities

  • Drive global execution of site activation for clinical trials
  • Advocate for optimized site selection strategies
  • Lead development and alignment of site activation projections
  • Ensure compliance of site start-up documentation in TMF
  • Develop comprehensive global country start up strategy
  • Monitor country intelligence for informed decision-making
  • Lead all aspects of site start-up activities and document collection
  • Serve as the subject matter expert for site documents
  • Oversee CRO management and site start-up processes
  • Represent SSU on cross-functional teams and resolve issues
  • Recommend process improvements across functions

Benefits

  • Collaborative work environment with cross-functional teams
  • Opportunity for strategic leadership and hands-on project management
  • Access to data-driven tools and insights for decision making
  • Professional development through process improvement initiatives
  • Potential for career growth in a global organization
  • Involvement in cutting-edge clinical research projects
  • Flexibility with occasional travel requirements
Full Job Description
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.

When & where:

This role is an in office role in either Warren, NJ or Armonk, NY

Discover your role:
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.

This role requires:
  • A Bachelor's degree and 6+ years relevant work experience
  • 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
  • May require up to 25% travel

Salary Range (annually)
$114,800.00 - $187,400.00

About Regeneron Pharmaceuticals, Inc

Regeneron Pharmaceuticals is a biopharmaceutical company that discovers, develops, and commercializes pharmaceutical products for the treatment of serious medical conditions. The Company has therapeutic candidates in clinical trials for the potential treatment of cancer, eye diseases, and inflammatory diseases, and has preclinical programs in other diseases and disorders. The company’s product portfolio includes EYLEA, an aflibercept injection; ARCALYST, a rilonacept Injection for subcutaneous use; ZALTRAP for metastatic colorectal cancer; trap fusion proteins; and fully human monoclonal antibodies. On March 26, 2012, it was announced that Sanofi and Regeneron are in development with a new cholesterol drug which will help reduce cholesterol up to 72%. Regeneron Pharmaceuticals was founded in 1988 and is currently headquartered in New York, USA.

Regeneron Pharmaceuticals, Inc Careers

Join the innovative team at Regeneron Pharmaceuticals, Inc, a leading biotechnology company renowned for its commitment to science-driven solutions. This is an unparalleled opportunity to advance your career with a company at the forefront of medical breakthroughs and clinical research.

Work You’ll Do

At Regeneron Pharmaceuticals, Inc, you will collaborate with some of the brightest minds in the industry, engaging in work that directly contributes to the health and well-being of populations globally. Our diverse team of professionals is dedicated to pioneering developments in biotechnology through continuous innovation and rigorous research.

Explore Job Opportunities and Growth

Regeneron offers a variety of job opportunities that encourage professional growth and personal achievement. Whether you're seeking an entry-level position or a more senior role, you will find a path that aligns with your career ambitions and skills. Our supportive culture emphasizes leadership development and diversity training, ensuring every team member can thrive.

Internship Programs

Kickstart your career with a Regeneron internship. Our programs provide invaluable industry experience, mentoring from seasoned professionals, and opportunities to develop skills that are crucial in the biotech field. Interns at Regeneron gain hands-on experience, contributing to projects that matter.

Benefits and Culture

Choosing to work at Regeneron Pharmaceuticals, Inc means choosing a career that comes with competitive benefits designed to support you both professionally and personally. We offer comprehensive health benefits, retirement plans, and wellness programs. Our inclusive culture fosters an environment where every employee can flourish, driven by collaboration and mutual respect.

Innovation and Leadership

Lead the way in biotechnological innovation with Regeneron. Our leadership is constantly looking towards the future, investing in cutting-edge technology and research that pave the way for medical advancements. At Regeneron, leadership and innovation go hand in hand, creating a dynamic where breakthroughs are common.

Networking and Professional Development

Enhance your professional network and skill set through Regeneron’s extensive networking opportunities and ongoing professional development programs. We believe in nurturing our talent with advanced training sessions and regular workshops that cover the latest trends and technologies in the biotech industry.

Join Our Team

Discover the impact you can make in a career at Regeneron Pharmaceuticals, Inc. Search for open positions that match your skills and interests. We are continuously hiring and looking for passionate, curious, and innovative team players.

Stay Connected

Keep up to date with the latest at Regeneron by following our careers blog. Gain insights from the experts and learn more about the exciting world of biotech at Regeneron Pharmaceuticals, Inc.

Prepare for Your Interview

Ready to join us? Prepare your resume and refine your interview skills to become part of a company that’s dedicated to changing lives. Personalize your job search and get tailored job alerts directly to your inbox, so you never miss an opportunity to be part of our team. At Regeneron Pharmaceuticals, Inc, your career is poised for tremendous growth and innovation. Explore the opportunities today and be part of a team that’s shaping the future of biotechnology.
Learn more about Regeneron Pharmaceuticals, Inc
Size
10,368 employees
Market Cap
$78.1 billion
Industry
Pharmaceuticals & Biotech
Net Income
$3.5 billion
Founded
1988
5 Year Trend
+27%
Revenue
$8.4 billion
NASDAQ
REGN
* Ladders Estimates

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at Regeneron Pharmaceuticals, Inc

More Pharmaceuticals & Biotech Jobs

Find similar Manager, Global Site Start-Up Lead jobs:

NationwideWarren, MI