[Remote] Senior Clinical Research Scientist II
Note: The job is a remote job and is open to candidates in USA. Caribou Biosciences is a leading clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. The Senior Clinical Research Scientist II plays a key role in the clinical development of allogeneic CAR-T therapies for hematologic malignancies, leading study-level activities and contributing to clinical strategy.ResponsibilitiesLead clinical study in execution, including planning, conduct, data review, and reporting for Phase I and II trials in hematologic malignanciesOwn ongoing clinical data review, ensuring patient safety and data integrity; identify trends and drive data informed decisionsLead safety monitoring activities including review of adverse events and CAR-T associated toxicities (ie: CRS, ICANS) and contribute to dose escalation decisionsDrive cross-functional collaboration with Clinical Operations, Translational Sciences, Data Management, Biostatistics, Regulatory, and CMC teams to ensure high-quality study executionLead authorship of key study documents, including protocols, Investigator’s Brochures, clinical study reports, regulatory documents, and safety narrativesIntegrate clinical and translational data (ie: cell expansion, persistence, biomarker data) to generate insights and inform program strategyContribute to regulatory strategy and submissions, including IND-related documents and health authority responsesServe as a scientific lead at the study level, engaging with investigators, CROs, and key opinion leadersSupport development of publications, abstracts, and presentations for scientific conferencesEnsure compliance with GCP, internal SOPs, and regulatory requirementsSkillsPhD/PharmD with 5+ years of experience in clinical development; MA/MS/MSN and 8+ years of experience; BA/BS/BSN and 10+ years of experienceExperience in hematology-oncology drug developmentExperience with CAR-T or cell therapy developmentDemonstrated ownership of clinical studies, preferably early phase trialsStrong scientific writing and communication skillsExperience with GCP and regulatory requirementsExperience with clinical data review and interpretation (including data listings)Ability to analyze and synthesize complex clinical and biomarker dataAbility to travel 30% based on business needsExperience in fast paced biotech environmentExperience with product launch or late stage development activitiesBenefitsComprehensive compensation package, which includes competitive salary, bonus, and equity for all employeesGenerous paid vacation time, in addition to company-observed holidaysExcellent medical, dental, and vision insurance401(k) retirement savings plan, which includes matching employer contributionsEmployee stock purchase plan (ESPP)Tuition reimbursement programCompany OverviewCaribou Biosciences is a biotechnology company that develops CRISPR technologies and allogenic cell therapies for oncology. It was founded in 2011, and is headquartered in Berkeley, California, USA, with a workforce of 51-200 employees. Its website is http://www.cariboubio.com.