Position SummaryWe 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.
Key responsibilities include:- 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
Qualifications:- 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
- Experience in designing and execution of translational research, in-vitro and in-vivo pharmacology, and mechanism of action studies is preferred
- 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
Caribou compensation and benefits include:- Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employees
- Salary Range: $175,000 - $195,000, this represents the present low and high end of the Company's pay range for this position; Actual pay will vary based on various factors, including but not limited to location, skill, experience, and performance
- 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
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.
