Manager, Precision Medicine Operations
Regeneron
July 02, 2026
Remote friendly (Tarrytown, NY)
United States
Operations
Manager, Precision Medicine Clinical Laboratory Study Management (CLSM Manager)
Responsibilities:
- Lead and develop a team of Clinical Laboratory Study Managers (CLSM) across therapeutic areas (including Immuno-Oncology).
- Partner with Precision Medicine Strategy Lead (PMSL), clinical study teams, data management (DM), Samples/Kits/Data/Logistics (SKDL), CLSM, and Clinical Laboratory Project Management (CLPM) to deliver high-quality samples and data.
- Build lab database with project/set-up managers to support clinical trial sample collection needs, kits, testing, and logistics.
- Monitor acquisition of clinical trial samples and ensure compliance with ICF permissions.
- Support clinical study teams on technical/operational sample matters; liaise with stakeholders on ICF and trial documents affecting samples/testing.
- Coordinate with central/specialty lab project managers, clinical trial management team, and CRO to ensure samples are collected per protocol and resolve sample issues.
- Oversee study start-up, closeout, and life-cycle activities for assigned studies.
- Provide input to sample-related protocol/ICF and supporting documents.
- Work with DM lead and SKDL to define how sample/testing data are captured, blinded, and transferred.
- Enable vendor sample/testing data transfer via data transfer specifications and related documents (with SKDL).
Qualifications:
- Bachelor’s degree; minimum 8 years pharmaceutical experience in matrix interaction (industry preferred) or cross-disciplinary academic/government teams.
- Minimum 5 years clinical trials experience, focused on clinical sample collection.
- Extensive experience in clinical laboratory operations and/or biospecimen logistics and clinical study experience.
- Strong understanding of technical, clinical, and strategic aspects of laboratory operations delivery.
Application:
- Apply now.
Salary Range (annually): $114,800.00 - $187,400.00
Responsibilities:
- Lead and develop a team of Clinical Laboratory Study Managers (CLSM) across therapeutic areas (including Immuno-Oncology).
- Partner with Precision Medicine Strategy Lead (PMSL), clinical study teams, data management (DM), Samples/Kits/Data/Logistics (SKDL), CLSM, and Clinical Laboratory Project Management (CLPM) to deliver high-quality samples and data.
- Build lab database with project/set-up managers to support clinical trial sample collection needs, kits, testing, and logistics.
- Monitor acquisition of clinical trial samples and ensure compliance with ICF permissions.
- Support clinical study teams on technical/operational sample matters; liaise with stakeholders on ICF and trial documents affecting samples/testing.
- Coordinate with central/specialty lab project managers, clinical trial management team, and CRO to ensure samples are collected per protocol and resolve sample issues.
- Oversee study start-up, closeout, and life-cycle activities for assigned studies.
- Provide input to sample-related protocol/ICF and supporting documents.
- Work with DM lead and SKDL to define how sample/testing data are captured, blinded, and transferred.
- Enable vendor sample/testing data transfer via data transfer specifications and related documents (with SKDL).
Qualifications:
- Bachelor’s degree; minimum 8 years pharmaceutical experience in matrix interaction (industry preferred) or cross-disciplinary academic/government teams.
- Minimum 5 years clinical trials experience, focused on clinical sample collection.
- Extensive experience in clinical laboratory operations and/or biospecimen logistics and clinical study experience.
- Strong understanding of technical, clinical, and strategic aspects of laboratory operations delivery.
Application:
- Apply now.
Salary Range (annually): $114,800.00 - $187,400.00