Quality Manager overseeing the execution of strategic quality plans in a manufacturing setting. Ensure compliance with internal and external quality standards while managing a quality department in Farwell, Michigan.
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
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