Manager/Sr. Manager, Clinical Assay Operations
Responsible for managing a portfolio of clinical assays required for the clinical development of investigational, CRISPR gene-edited cell therapies. This person will be a core member of the drug development team and is responsible for identifying clinical assays required for the trials (in collaboration with the Medical Director), developing novel assays (in collaboration with PCAD assay developers), identifying and qualifying appropriate clinical vendors, transferring assays to the vendors, and managing the vendor logistics and relationships.
- Identify and document portfolio of assays required for clinical trials (primary endpoints, secondary endpoints and exploratory assays)
- Collaborate with discovery/pre-clinical scientists, translational pharmacologist, Clinical Scientist/Medical Director and Clinical Operations
- Collaborate with assay development scientists at CRISPR Therapeutics to ensure that all novel assays are developed
- Contract and manage clinical vendors which will perform clinical assays required for a trial
- Communicate patient sample requirements for all clinical assays and exploratory research purposes to the Clinical Scientist and/or Trial Manager
- Develop “sample journey” plans for all samples required for clinical assay and exploratory research
- For samples requiring biorepository storage, ensure that sample logistics are in place with the biorepository
- Manage the progress and logistics related to the conduct of clinical assays during the trial
- Manage vendor relationships and troubleshoot where necessary
- BS degree or higher educational training in a field related to the health sciences
- At least 5 years of experience in managing clinical trials and/or clinical assays/management in a biotech or pharmaceutical setting
- An understanding of clinical drug development and requirements for associated clinical assays
- A PhD or PharmD in a health-related field
- 10+ years of experience in clinical trials and/or clinical assay management in a biotech or pharmaceutical setting
- Experience with development of Cell and Gene Therapy or ATMP products, and development requirements
- Experience in clinical assay development
- Experience in developing immuno-oncology therapies, including CAR T therapies
- 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, 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.