Manager, Precision Medicine Operations

Scorpion Therapeutics; Armonk (NY); On-site; USD 115,000 - 187,000; Full time

Job summary

Scorpion Therapeutics is seeking a senior leader to head Clinical Laboratory Study Managers (CLSM) across therapeutic areas such as Immuno-Oncology. You will partner with PMs, DM, SKDL, and CROs to ensure high-quality samples and data for clinical trials.

The role requires a Bachelor’s degree with 8+ years in pharma, plus 5+ years in clinical trials focused on sample collection and extensive lab operations experience.

Qualifications

• Bachelor’s degree and 8+ years of pharmaceutical experience; preferably in pharma/biotech or cross-disciplinary teams.
• 5+ years in Clinical Trials focused on clinical sample collection.
• Extensive experience in clinical laboratory operations, biospecimen logistics, and/or clinical study experience.
• Strong understanding of technical, clinical, and strategic aspects of laboratory operations delivery.

Responsibilities

• Lead and develop a team of Clinical Laboratory Study managers (CLSM) for therapeutic areas including Immuno-Oncology.
• Partner with PMSL, clinical study teams, DM, SKDL, CLSM, and CLPM to deliver high-quality samples and data.
• Build lab databases with project/setup managers to support trial sample collection needs, kits, testing, and logistics.
• Monitor acquisition of clinical trial samples and ensure compliance with ICF permissions.
• Liaise with internal stakeholders on ICF and other trial documents impacting samples/testing to support study teams.
• Coordinate with lab project managers, CLPM, and CRO to ensure protocol-compliant sample collection and resolve sample issues.
• Oversee study start-up, closeout, and lifecycle activities for assigned studies to support samples and testing.
• Provide input on sample-related sections of protocols/ICF and supporting documents.
• Define data capture, blinding, and transfer for sample/testing data with data management and SKDL.
• Enable vendor sample/testing data transfer via development/review of data transfer specifications and documents.

Skills

Clinical trials

Pharmaceutical experience

Biospecimen logistics

Lab operations

Education

Bachelor’s degree

Job description

Discover Your Role:

• Lead and develop a team of Clinical Laboratory Study managers (CLSM) for 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 databases with project and setup managers to support clinical trial sample collection needs, kits, testing, and logistics.
• Monitor acquisition of clinical trial samples (e.g., human tissue, bone marrow aspirate, whole blood, plasma, serum) and ensure compliance with ICF permissions.
• Liaise with internal stakeholders on ICF and other trial documents impacting samples/testing to support study teams.
• Coordinate with central/specialty lab project managers, clinical trial management team, and CRO to ensure protocol-compliant sample collection and resolve sample issues.
• Oversee study start-up, closeout, and lifecycle activities for assigned studies to support samples and testing.
• Provide input on sample-related sections of protocols/ICF and supporting documents.
• With data management lead and SKDL, define how sample/testing data will be captured, blinded, and transferred for clinical trials.
• Enable vendor sample/testing data transfer via development/review of data transfer specifications and documents.

This Role Requires:

• Bachelor’s degree and 8+ years of pharmaceutical experience; preferably in pharma/biotech or academic/government cross-disciplinary teams.
• 5+ years in Clinical Trials focused on clinical sample collection.
• Extensive experience in clinical laboratory operations, biospecimen logistics, and/or clinical study experience.
• Strong understanding of technical, clinical, and strategic aspects of laboratory operations delivery.

Benefits/Compensation:

• Salary Range (annually): $114,800.00 - $187,400.00