Senior Manager of Clinical Biomarkers at Caribou Biosciences, Inc.

Berkeley, California, United States -

Full Time

Start Date

Immediate

Expiry Date

13 Jan, 26

Salary

200000.0

Posted On

15 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Biomarkers, Translational Research, Oncology, Immunology, Clinical Trials, Biopharmaceutical Industry, Regulatory Submissions, Data Analysis, Communication Skills, Multiple Myeloma, Biomarker Development, Pharmacology, Mechanism Of Action, Vendor Management, Team Collaboration, Patient Selection

Industry

Biotechnology Research

Description

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 and autoimmune diseases. 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. 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 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 Caribou compensation and benefits include: Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employees Salary Range: $170,000 - $200,000. 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. Caribou is an equal opportunity employer and does not discriminate based on race, color, religion, marital status, age, national origin, ancestry, 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, hair texture or type or any other basis protected by law. In addition, 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, 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. We do not accept unsolicited resumes or candidate submissions from staffing agencies. All agencies must have a valid written agreement with Caribou Biosciences, Inc. for service in place. Any resume or candidate submitted by a staffing agency without such an agreement in place will be considered unsolicited, and Caribou Biosciences, Inc. will not be obligated to pay any referral or placement fee.

Responsibilities

Lead the development and execution of clinical biomarker plans aligned with Caribou’s clinical development strategy. Oversee the discovery, validation, and qualification of biomarkers to inform treatment response evaluation of Caribou’s allogeneic cell therapy drug products.