Specialist, Biomarker Operations
CRISPR Therapeutics
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. 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.
Job description
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. 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.
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.
- 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.
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.
Requirements
- 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
Benefits
- Bonus
- Equity
- Health Insurance
Company overview
CRISPR Therapeutics AG is a pioneering Swiss-American biotechnology company founded in 2013 that specializes in developing transformative gene-based medicines using the revolutionary CRISPR/Cas9 gene editing platform. Headquartered in Zug, Switzerland with major R&D operations in Boston, Massachusetts and San Francisco, California, the company was co-founded by Nobel Prize winner Emmanuelle Charpentier and represents one of the first commercial entities to harness CRISPR technology for therapeutic applications. CRISPR Therapeutics achieved a historic milestone in December 2023 with the FDA approval of CASGEVY® (exagamglogene autotemcel), the world's first CRISPR-based therapy for treating sickle cell disease and transfusion-dependent beta thalassemia. The company maintains a diverse pipeline targeting hemoglobinopathies, oncology, regenerative medicine, cardiovascular diseases, autoimmune disorders, and rare genetic conditions. Through strategic partnerships with industry leaders like Vertex Pharmaceuticals and Bayer, CRISPR Therapeutics continues to advance its innovative platform, employing approximately 400 professionals globally and maintaining a strong financial position with over $1.8 billion in cash and marketable securities as of 2025.