Senior Manager, Clinical Lab Project Management

Regeneron Pharmaceuticals, Inc.

Armonk (NY)

Remote

USD 134,000 - 219,000

Full time

26 hours ago
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Job summary

Regeneron Pharmaceuticals, Inc. invites a Senior Manager to lead Precision Medicine Clinical Laboratory Operations. Remote US-based or on-site in Warren, NJ or Armonk, NY, four days a week on-site when required.

You will coordinate across clinical labs, biomarker delivery, and trial teams to ensure timely study starts and data delivery. The role requires a strong background in clinical laboratory operations, trial management, and cross-functional collaboration to support early and late-stage

Qualifications

  • Minimum 10 years in pharmaceutical/biotech labs or related cross-disciplinary teams.
  • At least 5 years of experience with clinical trials and clinical laboratory operations.
  • Strong understanding of laboratory operations, biospecimen logistics, and trial requirements.

Responsibilities

  • Oversee clinical laboratory portfolio management for Regeneron trials and monitor timelines and risks.
  • Serve as SME on central and specialty lab processes and coordinate with cross-functional partners.
  • Maintain biomarker strategy delivery schedules and mitigation plans for studies.
  • Drive program-level laboratory management with clear objectives and deadlines.
  • Foster relationships with Precision Medicine Lab Study Management and Global Development teams.
  • Communicate laboratory program directions and ensure harmonized lab delivery from onset to data finalization.
  • Lead process improvements to Clinical Laboratory Project Management within the matrix organization.

Skills

Clinical operations
Project management
Risk management
Cross-functional
Biomarker strategy
Study coordination
Stakeholder mgmt

Education

Bachelor's degree
Master's degree

Job description

Build Our Future Together At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager, Precision Medicine Clinical Laboratory Operations will be responsible for Clinical Laboratory Project & Program management for various therapeutic areas working closely with Director, Precision Medicine Clinical Laboratory Operations and key cross-functional collaborators. The primary role will be to keep laboratory deliverables across the portfolio on track, ensuring that study start timelines are met, provide risk management. This will be done in collaboration with Precision Medicine Strategy Leads, Clinical Trial Management, Clinical Laboratory Operations Management, Global Development colleagues and central and specialty testing laboratories to support early and late-stage programs within our pipeline.

Build Our Future Together At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager, Precision Medicine Clinical Laboratory Operations will be responsible for Clinical Laboratory Project & Program management for various therapeutic areas working closely with Director, Precision Medicine Clinical Laboratory Operations and key cross-functional collaborators. The primary role will be to keep laboratory deliverables across the portfolio on track, ensuring that study start timelines are met, provide risk management. This will be done in collaboration with Precision Medicine Strategy Leads, Clinical Trial Management, Clinical Laboratory Operations Management, Global Development colleagues and central and specialty testing laboratories to support early and late-stage programs within our pipeline.

When & Where

This role can be based remotely (in the US) or sit on‑site in our Warren, NJ or Armonk, NY office. If on‑site, the role would be expected to be on‑site four days per week.

Discover Your Role
  • Perform clinical laboratory portfolio management for Regeneron clinical trials and review clinical laboratory operations timelines and risks and be able to manage and communicate risks and ensure study starts and data delivery are aligned with expectations
  • Be a subject matter expert on central and specialty laboratory processes and leverage this knowledge to be a trusted collaborator and ensure clinical laboratory deliverables
  • Keep biomarker strategy delivery schedules for clinical development programs and studies on track, identifying and tracking risks and decisions, creating mitigation plans
  • Manage clinical laboratory operations goals, including progress, schedules of testing/data generation across the portfolio with clear objectives and deadlines
  • Manage strong relationships and trust with internal and cross functional partners, including Precision Medicine Clinical Lab Study Management, Precision Medicine Strategy Leads and others within Global Development to manage and implement program level clinical laboratory management
  • Demonstrate relevant knowledge and understanding of clinical laboratory trial requirements on the program and implement operational decisions. Ensure the laboratory portion of the studies are harmonized for assigned program from onset to final delivery
  • Be viewed as an operational subject matter expert to effectively communicate with clinical study teams on laboratory program direction. Demonstrate authority for the studies related to the program.
  • Create and communicate enhancements to Clinical Laboratory Project Management and connections through the matrix environment, design and develop processes to address identified gaps
This Role Requires
  • Bachelors degree required, Masters degree preferred.
  • Minimum of 10 years experience preferably in a pharmaceutical or biotech industry, or in academic or governmental cross-disciplinary teams.
  • Minimum of 5 years’ experience with Clinical Trials, focus on clinical sample collection. Extensive experience in Clinical laboratory operations, biospecimen logistics, and/or clinical study experience requested.
  • We need a strong understanding of technical, clinical, and strategic aspects of laboratory operations delivery required. We are seeking clinical study knowledge, demonstrated by knowledge in science and technology.

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.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$134,400.00 - $219,200.00

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