Clinical Sample Senior Specialist/Manager, Translational Pharmacology

Company: CRISPR Therapeutics
Location: Somerville
Posted on: January 12, 2021

Job Description:

Company OverviewAt CRISPR Therapeutics, we are focused on developing transformative gene-based medicines for serious human diseases.We are rapidly translating our specific, efficient, and versatile CRISPR/Cas9 gene-editing platform into therapies to treat hemoglobinopathies, cancer, diabetes, and other diseases.Our multi-disciplinary team of world-class researchers and drug developers works every day to translate our CRISPR/Cas9 technology into breakthrough human therapeutics. Our lead program targeting the blood diseases ---thalassemia and sickle cell disease has entered clinical testing, and our immuno-oncology programs, focused on CRISPR/Cas9-edited allogeneic CAR-T cell therapies, have the potential to deliver a new generation of cancer therapies to patients.Job SummaryUnder guidance of the Head of Translational Pharmacology Operations, the Sample Manager provides hands-on operational support to clinical study teams, particularly in the day to day planning and execution of clinical studies and management of samples. Duties will include development and maintenance of documentation, including clinical sample journey plans, and managing the sample logistics. ResponsibilitiesServe as a critical member of the Clinical study team Contribute to and maintain schedule of assessments, lab manuals, and trial kit designsDevelop and maintain ---sample journey--- plans for all samples required for clinical assay testing and exploratory researchCommunicate patient sample requirements for all clinical assays and exploratory research purposes to Clinical Operations, Clinical Scientist and/or Trial ManagerDevelop and communicate sample related logistics for clinical sitesEnsure samples are properly routed to the receiving labs during the trialFor samples requiring biorepository storage, ensure that sample logistics are in place and samples are properly transitioned to biorepositoryWillingness to travel both domestically and internationally, as needed, to support site and CRO visitsMinimum QualificationsDegree in life sciences with demonstrated experience in clinical drug development processes as evidenced by 3-5 years in a life sciences organization Experience in clinical trial operationsExpert planning and tracking skills, with the ability to capture detailsAbility to work in a matrixed environmentExcellent oral and written communication skills (in English)Strong interpersonal skillsWell organized, focused on results, capable of managing multiple projects, excellent time management skills with respect to priorities and self-managementPreferred QualificationsB.S or higher degree with 6 years in the biotech/pharma industry, preferably in Clinical OperationsExperience in immuno-oncology clinical trials Experience with Cell and Gene Therapy or ATMP product clinical trials, including CAR T cell therapiesSummaryLocation: Cambridge, MA, United StatesType: Full TimeExperience: Manager/SupervisorDepartment: Translational Pharmacology

Keywords: CRISPR Therapeutics, Somerville , Clinical Sample Senior Specialist/Manager, Translational Pharmacology, Executive , Somerville, Massachusetts