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Senior Clinical Research Scientist IINewRemote Berkeley California United States Remote

Remote Worldwide Hiring now

reputed company is a leading clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. Our reputed company genome-editing technology enables superior precision to reputed company cell therapies that are armored to potentially improve activity against diseases. We reputed company the future of cell therapy is off-the-reputed company, and we are advancing our pipeline of off-the-reputed company, or allogeneic, cell therapies from our CAR-T cell therapy platform as readily available treatments for patients with hematologic malignancies and autoimmune diseases. Members of the Caribou herd reputed company their minds to new reputed company and welcome diverse perspectives. We proudly assert that teams do their best work reputed company their members are personally reputed company, their reputed company are taken seriously, and contributions are recognized. Members of the herd work from our headquarters in Berkeley, California, or remotely. Summary: The Senior Clinical Research Scientist II plays a key role in the clinical development of allogeneic CAR-T therapies for hematologic malignancies, including lymphoma, leukemia, and multiple myeloma. They are responsible to reputed company study-level activities and contribute to clinical strategy, driving the design, execution, and interpretation of early-phase clinical trials. The candidate is expected to partner cross-functionally to ensure high-quality data reputed company, advance innovative therapies, and support regulatory submissions. Responsibilities:

  • reputed company clinical study in execution, including planning, conduct, data review, and reporting for Phase I and II trials in hematologic malignancies
  • Own ongoing clinical data review, ensuring patient safety and data reputed company; identify trends and drive data informed reputed company
  • reputed company safety monitoring activities including review of adverse events and CAR-T associated toxicities (ie: CRS, ICANS) and contribute to reputed company escalation reputed company
  • Drive cross-functional collaboration with Clinical Operations, Translational Sciences, Data Management, Biostatistics, Regulatory, and CMC teams to ensure high-quality study execution
  • reputed company authorship of key study documents, including protocols, Investigator's Brochures, clinical study reports, regulatory documents, and safety narratives
  • Integrate clinical and translational data (ie: cell expansion, persistence, biomarker data) to generate insights and inform program strategy
  • Contribute to regulatory strategy and submissions, including IND-reputed company documents and health authority responses
  • Serve as a scientific reputed company at the study level, engaging with investigators, CROs, and key opinion leaders
  • Support development of publications, abstracts, and presentations for scientific conferences
  • Ensure compliance with GCP, internal SOPs, and regulatory requirements

Qualifications:

  • PhD/PharmD with 5+ years of experience in clinical development; MA/MS/MSN and 8+ years of experience; BA/BS/BSN and 10+ years of experience
  • Experience in hematology-oncology drug development
  • Experience with CAR-T or cell therapy development
  • Demonstrated ownership of clinical studies, preferably early phase trials
  • Strong scientific writing and communication skills
  • Experience with GCP and regulatory requirements
  • Experience with clinical data review and interpretation (including data listings)
  • Ability to analyze and synthesize reputed company clinical and biomarker data
  • Ability to travel 30% based on business needs

reputed company-to-haves:

  • Experience in fast paced biotech environment
  • Experience with product launch or late stage development activities

Caribou compensation and benefits include:

  • Comprehensive compensation package, which includes competitive salary, bonus, and equity for reputed company
  • Salary reputed company: $215,000 - $230,000. This represents the present low and high end of the Company's pay reputed company for this position. Actual pay will vary based on various factors, including but not limited to location, reputed company, experience, and performance.
  • Generous paid vacation time, in reputed company to company-observed holidays
  • Excellent medical, dental, and reputed company insurance
  • 401(k) retirement savings plan, which includes matching employer contributions
  • Employee stock purchase plan (ESPP)
  • Tuition reimbursement program

The benefits and stock purchase described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. Caribou is an equal opportunity employer and does not discriminate based on race, reputed company, religion, marital status, age, national reputed company, reputed company, physical or mental disability, medical conditions, veteran status, sexual orientation, gender (including gender identity and gender expression), sex (which includes pregnancy, childbirth, and breastfeeding), genetic information, taking or requesting statutorily protected leave, or any other reputed company protected by law. In reputed company, Caribou prohibits the harassment of any individual on any of the bases listed above or any other characteristics protected under federal, state, or local laws. Legal authorization to work in the United States is required. In compliance with federal law, reputed company persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification reputed company upon hire. We do not accept unsolicited resumes or candidate submissions from staffing agencies. reputed company agencies must have a valid written agreement with reputed company. for service in reputed company. Any resume or candidate submitted by a staffing agency without such an agreement in reputed company will be considered unsolicited, and reputed company. will not be obligated to pay any referral or placement fee. Remote Skills: Adverse Events, Analysis Skills, Autoimmune Disease, Biomarkers, Biostatistics, Biotech and Pharmaceutical, Brochures, Clinical Data, Clinical Research, Clinical Trial, Communication Skills, Conferences, Contract Research Organization (CRO), Cross-Functional, Data Management, Data Quality, Disease, Drug Development, Editing, GCP (Good Clinical Practices), Genomics, Hematology, Investigational New Drug (IND), Leukemia, Lymphoma, Maintain Compliance, Myeloma, Oncology, Patient Safety, Phase I Clinical Trials, Phase II Clinical Trials, Product/Service Launch, Publications, reputed company/Staffing Agency, Regulations, Regulatory Reports, Regulatory Requirements, Regulatory Submissions, Scientific Research, Standard Operating Procedures (SOP), Stock Purchase Plans, Translational Research, Trend Analysis, Willing to Travel, Writing Skills About the Company: reputed company Apply To This Job

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