Senior Manager, Clinical Lab Project Management

Regeneron Pharmaceuticals; Warren (MI); Hybrid; USD 134,000 - 219,000; Full time

Job summary

Regeneron Pharmaceuticals in the United States is seeking a Senior Manager, Precision Medicine Clinical Laboratory Operations to lead clinical laboratory project and program management across therapeutic areas. You will partner with cross-functional teams to keep study deliverables on track and align start timelines with data delivery.

This role requires deep knowledge of central and specialty lab processes, biomarker strategy delivery, and risk management.

Qualifications

• Bachelor's degree required, Master's degree preferred.
• 10+ years of experience in pharmaceutical/biotech or cross-disciplinary teams.
• 5+ years' experience with Clinical Trials, focusing on clinical sample collection; extensive clinical laboratory operations experience.
• Strong understanding of laboratory operations delivery and clinical study knowledge.

Responsibilities

• Manage clinical laboratory portfolio and review timelines/risks to ensure study starts and data delivery meet expectations.
• Be a subject matter expert on central and specialty laboratory processes and collaborate to ensure deliverables.
• Maintain biomarker strategy delivery schedules and identify risks with mitigation plans.
• Oversee laboratory operations goals and schedules across the portfolio with clear objectives and deadlines.
• Foster strong relationships with internal and cross-functional partners to manage program-level clinical laboratory management.
• Implement operational decisions to harmonize the laboratory portion of studies from onset to final delivery.
• Communicate laboratory program direction to study teams with authority.
• Create and communicate enhancements to Clinical Laboratory Project Management and develop processes to address gaps.

Skills

Clinical trial management

Cross-functional collaboration

Risk management

Stakeholder engagement

Education

Bachelor's degree

Master's degree preferred

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.

When & Where:

This role can sit on-site in our Warren, NJ or Armonk, NY office. The role is 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. 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 -site. Please speak with your recruiter and hiring manager for more information about -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.

Salary Range (annually)

$134,400.00 - $219,200.00