Senior Manager of Clinical Biomarkers

Caribou Biosciences, Inc.•Berkeley, CA

12d•$175,000 - $195,000•Hybrid

About The Position

Caribou Biosciences is a leading clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. Our next-generation genome-editing technology enables superior precision to develop cell therapies that are armored to potentially improve activity against diseases. We believe the future of cell therapy is off-the-shelf, and we are advancing our pipeline of off-the-shelf, or allogeneic, cell therapies from our CAR-T cell therapy platform as readily available treatments for patients with hematologic malignancies. Members of the Caribou herd open their minds to new ideas and welcome diverse perspectives. We proudly assert that teams do their best work when their members are personally engaged, their ideas are taken seriously, and contributions are recognized. Members of the herd work from our headquarters in Berkeley, California, or remotely. Position Summary We are seeking a highly motivated and experienced Senior Manager of Clinical Biomarkers to join our Translational Research team. The candidate will be accountable for implementing the clinical biomarker strategy of gene-edited allogeneic cell therapy clinical programs at Caribou with a particular emphasis on Multiple Myeloma programs. The candidate will generate biomarker insights crucial to ensuring precise patient selection, therapy response monitoring, and safety assessments. This is an exciting time to join the Translational Research team at Caribou, collaborate with an exceptional group of cell therapy professionals within both the translational research and clinical teams, and advance our clinical stage allogeneic cell therapy pipeline and technology.

Requirements

Ph.D. in Oncology/Immunology or related field with 5+ years of industry experience, preferably in oncology, including 3+ years in biomarkers, translational medicine, or correlative research
Proven ability to develop and execute biomarker plans aligned with overall clinical development goals and corporate objectives
Demonstrated experience in designing and leading clinical biomarker components of phase I-III clinical trials in the biopharmaceutical industry
Strong ability to analyze, interpret, and integrate biomarker and clinical data to drive decision-making in clinical trials
Experience in multiple myeloma regulations and clinically relevant biomarkers strategies and assays including PK/PD/MRD and exploratory biomarker assessments
Knowledge of cell therapy and multiple myeloma landscapes, including competitive products, emerging trends, and current challenges
Understanding of regulatory requirements and guidelines related to biomarker development and utilization in cell therapy clinical trials (e.g., FDA, EMA, ICH guidelines)
Experience managing external vendors and biomarker operations
Excellent written and verbal communication skills, including the ability to present complex biomarker data effectively to diverse audiences, including internal teams and senior management, external stakeholders, and regulatory agencies
Able to adapt to a dynamic and rapidly changing company environment, and to adjust their workload according to shifting priorities
Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

Nice To Haves

Experience in designing and execution of translational research, in-vitro and in-vivo pharmacology, and mechanism of action studies is preferred

Responsibilities

Lead the development and execution of clinical biomarker plans aligned with Caribou’s clinical development strategy
Familiarity with preparing, updating, and finalizing documentation for regulatory submissions such as biomarker-related sections in Clinical protocols, Investigator Brochures, Clinical Study Reports and other related clinical biomarker related documents
Lead biomarker-related activities across all phases of clinical trials, ensuring alignment with study objectives, timelines, and budget.
Organize, analyze results, interpret emerging clinical biomarker data, and communicate effectively at research and cross-functional meetings and senior management
Participate in program development teams and lead pertinent translational research working groups
Oversee the discovery, validation, and qualification of biomarkers and methods to inform mechanism of action, response/resistance, safety as well as disease monitoring, and treatment response evaluation of Caribou’s allogeneic cell therapy drug products
Liaise and support cross-functional translational research teams including computational biology, clinical teams and lab scientists for biomarker analysis, back-translation and exploration of translational strategies such as indication or patient selection