Hybrid Senior Manager – Clinical Biomarkers

at Caribou Biosciences

• Job title: Senior Manager – Clinical Biomarkers
• Job type: Full Time
• Experience level: Senior
• Salary: $170,000 - $200,000 per year
• Degree requirement: Postgraduate Degree
• Location requirements: Hybrid, Berkeley, United States

About the role

• Senior Manager of Clinical Biomarkers developing biomarker strategies at Caribou Biosciences for clinical programs. Collaborating with clinical teams on gene-edited allogeneic therapies focusing on Multiple Myeloma.

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

Requirements

• Ph.D. in Oncology/Immunology or related field with 5+ years of industry experience and 3+ years in oncology/biomarkers/translational or correlative research
• 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
• Familiarity with interpreting and integrating biomarker data to drive decision-making in clinical trials.
• Familiarity with multiple myeloma regulations and clinical biomarkers including but not limited to PK/PD/MRD assays
• Understanding of regulatory requirements and guidelines related to biomarker development and utilization in cell therapy clinical trials (e.g., FDA, EMA, ICH guidelines)
• Experience in designing and execution of translational research, in-vitro and in-vivo pharmacology, and mechanism of action studies is preferred
• Experience in 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
• Familiarity with cell therapy and multiple myeloma landscapes, including competitive products, emerging trends, and current challenges
• Able to adapt to a dynamic and rapidly changing company environment, and to adjust their workload according to shifting priorities

Benefits

• Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employees
• Generous paid vacation time, in addition to company-observed holidays
• Excellent medical, dental, and vision insurance
• 401(k) retirement savings plan, which includes matching employer contributions
• Employee stock purchase plan (ESPP)
• Tuition reimbursement program