Manager, Precision Medicine Operations

BioSpace; Armonk (NY); Hybrid; USD 115,000 - 187,000; Full time

Job summary

Regeneron is seeking a Manager, Precision Medicine Clinical Laboratory Study Management to lead a team of CLSMs across therapeutic areas, including Immuno-Oncology. You will drive precision medicine operations, partner with PMSL, DM, SKDL, CLDM, and CLPM to deliver high-quality samples and data for clinical trials.

You will manage life-cycle activities for central or specialty labs, ensure protocol-compliant sample collection, and coordinate data transfer with vendors and internal teams,

Qualifications

• Bachelor's degree required with pharma/biotech experience.
• Minimum of 5 years' experience in Clinical Trials or clinical sample collection.
• Extensive knowledge of laboratory operations and biospecimen logistics.
• Strong understanding of technical, clinical, and strategic lab delivery.

Responsibilities

• Collaborate with project and setup managers to build lab databases for sample collection needs.
• Monitor acquisition of clinical trial samples and ensure ICF compliance.
• Support study teams on technical and operational sample issues with stakeholders.
• Coordinate with central/specialty labs, trial management, and CROs to ensure on-protocol samples.
• Oversee study start-up, close-out, and lifecycle activities for labs and samples.
• Contribute to clinical trial documents and data transfer specifications with SKDL.

Skills

Cross-functional leadership

Clinical trial operations

Lab coordination

Education

Bachelor's degree

Job description

Build Our Future Together

The Manager, Precision Medicine Clinical Laboratory Study Management (CLSM Manager) will lead and develop a team of Clinical Laboratory Study managers (CLSM) for various therapeutic areas including Immuno-Oncology. In this role, you will be a key driver of precision medicine operational execution partnering with Precision Medicine Strategy Lead (PMSL), clinical study teams, data management (DM), Samples, Kits, Data, Logistics (SKDL), Clinical Laboratory Study Manager (CLSM), and Clinical Laboratory Project Management (CLPM) groups to deliver high-quality samples and data. Through strong cross functional collaboration and operational excellence, you will help ensure biomarker and non-biomarker strategies are executed seamlessly, enabling the translation of innovative science to medicines for patients.

Build Our Future Together

The Manager, Precision Medicine Clinical Laboratory Study Management (CLSM Manager) will lead and develop a team of Clinical Laboratory Study managers (CLSM) for various therapeutic areas including Immuno-Oncology. In this role, you will be a key driver of precision medicine operational execution partnering with Precision Medicine Strategy Lead (PMSL), clinical study teams, data management (DM), Samples, Kits, Data, Logistics (SKDL), Clinical Laboratory Study Manager (CLSM), and Clinical Laboratory Project Management (CLPM) groups to deliver high-quality samples and data. Through strong cross functional collaboration and operational excellence, you will help ensure biomarker and non-biomarker strategies are executed seamlessly, enabling the translation of innovative science to medicines for patients.

When & Where

• Work Location: Armonk, NY or Warren, NJ
• Hybrid: 4 days per week on site

Discover Your Role

• Works with project manager and set-up manager of central/specialty lab and clinical study team to build lab database to address clinical trial sample collection needs, kits, testing and logistics
• Monitors acquisition of clinical trial samples (including human tissue, bone marrow aspirate, whole blood, plasma, serum, etc.) and ensure compliance with ICF permissions
• Supports individual clinical study teams as required for all technical and operational sample-related matters for assigned projects by liaising with internal stakeholders working on ICF and other trial documents impacting samples and testing
• Work closely with central lab and/or specialty lab project managers, clinical trial management team, and CRO to ensure samples are collected per protocol and assist with resolving any sample related issues or queries.
• Oversees Study start up, closeout and overall life-cycle activities for assigned studies at central lab/specialty labs to support all samples and testing
• Provides input on sample-related section in clinical trial-related (e.g. protocols and ICF) and other supporting documents
• Works closely with data management lead and SKDL to determine how sample and testing data will be captured, blinded and transferred for clinical trials.
• Enables transfer of sample/testing data from vendors through development and review of appropriate data transfer specification and related documents in collaboration with SKDL.

This Role Requires

• A Bachelor\'s degree with a minimum of 8 years of pharmaceutical experience in matrix interaction 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.
• Strong understanding of technical, clinical, and strategic aspects of laboratory operations delivery required.

Does this sound like you? We are evaluating candidates for suitability. 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 onsite. Please speak with your recruiter and hiring manager for more information about onsite 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.

Salary Range (annually)

$114,800.00 - $187,400.00