Manager, Clinical Lab Project Management

BioSpace; United States; Remote; USD 115,000 - 187,000; Full time

Benefits offered by this job

Annual bonuses

Equity awards

Pension or retirement benefits

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits

Paid time off

Family support benefits

Job summary

Regeneron is seeking a Manager, Precision Medicine Clinical Laboratory Operations to lead clinical lab portfolio management and risk assessment across multiple therapeutic areas. This role collaborates with Precision Medicine Strategy Leads, Clinical Trial Management, and Global Development to ensure timely study starts and data delivery.

The ideal candidate will have extensive experience in clinical laboratory operations, biospecimen logistics, and clinical trial execution, with ability to

Qualifications

• Bachelor's degree required; master's preferred.
• Strong background in clinical laboratory operations and biospecimen logistics helpful.
• Experience with clinical trials and biotech/pharma environments is desirable.

Responsibilities

• Perform clinical laboratory portfolio management for Regeneron clinical trials and review timelines and risks.
• Manage and communicate risks to ensure study starts and data delivery align with expectations.
• Track biomarker strategy delivery schedules and identify risks, creating mitigation plans.
• Oversee laboratory operations goals, progress, and testing/data generation across the portfolio with clear deadlines.
• Liaise with Precision Medicine Clinical Lab Study Management, Strategy Leads, and Global Development teams.
• Demonstrate understanding of complex non-oncology clinical laboratory trial requirements and translate into operational decisions.
• Communicate study direction to clinical study teams and provide study-specific laboratory insights.

Skills

Clinical lab operations

Risk management

Cross-functional collaboration

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 Manager, Precision Medicine Clinical Laboratory Operations who 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 and 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 (within 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 complex Regeneron clinical trials and review clinical laboratory operations timelines and risks. Manage and communicate those risks to ensure study starts and data delivery are aligned with expectations
• Active knowledge on central and specialty laboratory processes; leverage this experience to be a trusted collaborator and ensure clinical laboratory deliverables
• Track biomarker strategy delivery schedules for clinical development programs/studies on track, identifying and tracking risks and decisions, creating mitigation plans
• Oversee clinical laboratory operations goals, including progress, schedules of testing/data generation across the portfolio with clear objectives and deadlines
• Liaise 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 understanding of complex non-oncology clinical laboratory trial requirements on the program and implement operational decisions and harmony.
• Communicate with clinical study teams on laboratory program direction. Demonstrate knowledge for the studies related to the program.

This Role Requires

• Bachelors degree required, Masters degree preferred.
• Minimum of 8 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.

Additional information

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:

Benefits

• 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., visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. 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): $114,800.00 - $187,400.00