Specialist, Biomarker Operations

CRISPR Therapeutics; Boston (MA); Sur place; USD 85 000 - 100 000; Plein temps

Avantages offerts par ce poste

Bonus

Equity

Benefits

Résumé du poste

CRISPR Therapeutics, a leading biopharmaceutical company, seeks a Clinical Operations specialist to manage biomarker sample flow and vendor relationships across clinical trials. The role emphasizes organization, cross-functional collaboration, and strict adherence to regulatory standards within a fast-paced science environment.

The successful candidate will support PK/PD and translational biomarker activities, ensuring timely data transfer, vendor coordination, and compliance with GCP and

Qualifications

• BS in related field with 3-5+ years of experience in clinical trial operations, biospecimen/sample management, or laboratory operations; advanced degree with 2-4+ years of relevant work experience.
• Strong organizational skills with high attention to detail and accuracy.
• Familiarity with PK, PD, immunogenicity, and biomarker assay types.
• Ability to manage multiple concurrent priorities and meet tight timelines across studies.
• Working knowledge of GCP and biospecimen handling regulations.

Responsabilités

• Identify vendors to support program-specific biomarker needs.
• Collaborate with Clinical Pharmacology Leads on vendor selection, scope-of-work review, and budget review for selected vendors.
• Collaborate with Clinical Pharmacology leads, Finance, and Legal to manage contracting and qualification of vendors.
• Track biomarker assay timelines and deliverables across multiple concurrent clinical programs.
• Liaise with central labs, biorepositories, and CROs to ensure timely sample processing and data transfer.
• Coordinate Data Transfer Agreements/Specifications with testing labs and Data Management, and track data transfers against study timelines.

Connaissances

Strong organizational skills

Clinical trial operations

GCP knowledge

Biomarker/sample management

Cross-functional collaboration

Formation

Bachelor's degree in related field

Advanced degree

Outils

Oracle

Conga

Description du poste

Job Description

Company Overview

Founded over a decade ago,CRISPR Therapeuticsis a leading biopharmaceutical company focused on developing transformative gene-based medicines for serious human diseases. The Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY®(exagamglogene autotemcel [exa-cel]), the world’s first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion-dependent beta thalassemia.CRISPR Therapeuticsis advancing a broad and diversified pipeline across hemoglobinopathies, cardiovascular, autoimmune, oncology, regenerative medicine and rare diseases. The Company continues to expand its leadership in gene editing through the development of SyNTase™ editing, a novel and proprietary gene-editing platform designed to enable precise, efficient, and scalable gene correction. To accelerate and expand its impact,CRISPR Therapeuticshas established strategic collaborations with leading biopharmaceutical partners, includingVertex Pharmaceuticals.CRISPR Therapeutics AGis headquartered inZug,Switzerland, with its wholly-ownedU.S.subsidiary,CRISPR Therapeutics, Inc., and R&D operations based inBoston, MassachusettsandSan Francisco,California.

Position Summary

This position will report into the Clinical Pharmacology Department. The successful candidate will support the lifecycle and data flow of biological samples in clinical trials and translational research. Your broad and wide-ranging experience in managing clinical trials and/or bioanalytical activities will create engagement and impact for the right candidate. This is an ideal opportunity for someone who thrives on organization, cross-functional coordination, and process rigor within a scientific/clinical environment — without requiring day-to-day bench science work. The desired candidate will demonstrate enthusiasm, passion, attention to detail, and a desire to create important new medicines for patients.

Responsibilities

Operational Support for PK, PD, and Translational Biomarkers

• Identify vendors to support program-specific biomarker needs.
• Collaborate with Clinical Pharmacology Leads on vendor selection, scope-of-work review, and budget review for selected vendors
• Collaborate with Clinical Pharmacology leads, Finance, and Legal teams to manage contracting and qualification of vendors
• rack biomarker assay timelines and deliverables across multiple concurrent clinical programs
• Liaise with central labs, biorepositories, and CROs to ensure timely sample processing and data transfer
• Coordinate Data Transfer Agreements/Specifications with testing labs and Data Management, and track data transfers against study timelines

Compliance & Documentation

• Ensure sample handling adheres to protocol-specific requirements, Good Clinical Practice (GCP), and applicable regulatory guidelines
• File vendor-related documents into the Trial Master File (TMF) to stay inspection-ready (e.g., meeting minutes, sample destruction documents)

Cross-Functional Coordination

• Serve as a key point of contact between Clinical Pharmacology, Clinical Operations, Data Management, Finance, Statistical Programming, and external vendors/labs
• Communicate sample testing status updates, risks, and timeline impacts to study teams
• Contribute to continuous improvement of sample management SOPs and workflows

Minimum Qualifications

• BS in related field with 3-5+ years of experience in clinical trial operations, biospecimen/sample management, or laboratory operations, or advanced degree and 2-4+ years of relevant work experience.
• Strong organizational skills with high attention to detail and accuracy
• Conceptual familiarity with PK, PD, immunogenicity, and biomarker assay types
• Ability to manage multiple concurrent priorities and meet tight timelines across studies
• Working knowledge of GCP and biospecimen handling regulations
• Ability to work independently and collaboratively in a fast-paced, cross-functional, results-oriented team environment
• Experience supporting project budgets and on-time, on-budget delivery

Preferred Qualifications

• Experience supporting biomarker or translational research programs, beyond general clinical operations
• Familiarity with cold-chain logistics and international shipping requirements for biological samples
• Prior experience working with central labs, biorepositories, or CROs
• Prior experience with contract management and procurement systems (e.g., Oracle, Conga)
• Exposure to informed consent/biobanking regulatory considerations

Competencies

• Collaborative – Openness, One Team
• Undaunted – Fearless, Can-do attitude
• Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems.
• Entrepreneurial Spirit – Proactive. Ownership mindset.

CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect. Certain lab based and manufacturing positions are located fully on-site.

Specialist: Base pay range of $85,000 to $100,000+ bonus, equity and benefits

The range provided is CRISPR Therapeutics’ reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities.

CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.

To view our Privacy Statement, please click the following link: http://www.crisprtx.com/about-us/privacy-policy