Associate Director/Director of Clinical Operations

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.

About the Role

The Associate Director/Director of Clinical Operations will serve as a cross-functional study team lead for one of the organization’s high priority hematology programs, bearing responsibility for the delivery of all operational activities. This role should be comfortable working collaboratively with various Caribou functional leads and providing strategic direction to the CRO.  They will demonstrate strong matrix management skills, problem solving, and team empowerment to achieve defined milestones.  They will operate within given budgets and timelines, and weigh this against shifts in the trial design, with transparency and a solution-driven approach.  Ideally, this candidate will have a particular focus on quality readiness. 

This candidate can be remotely based, and ideally attends relevant congresses, conducts on-site visits and joins the greater team at Caribou headquarters (Berkeley, CA) as able.

Responsibilities:

• Partner with CRO counterparts and assume oversight of the operational activities and deliverables for a key hematology program
• Lead study-specific and cross functional meetings as needed.  These meetings will be purposeful, timely and with clear action or resolution
• Evaluate the current state and leverage full breadth of professional experience to identify (and implement) efficiencies if applicable to maximize delivery of key milestones
• Review key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and follow-up with the Study Team to determine appropriate action, ensuring transparent communication and a solution-oriented approach
• Ensure that decision-making in the day-to-day activities of the CRO and key vendors is in alignment with the company's expectations and identify areas of concern for resolution and/or escalation
• Day-to-day activities may include Updating/reviewing study documents (protocols, informed consent forms, clinical study reports, site facing material, etc.), monitoring study status across internal functions and external vendors, and anticipating and mitigating risks within the timeline, quality, and study budget
• Review, negotiate and approve Clinical Operations' vendors' scopes of work (SOWs) and budgets
• Develop and maintain positive and productive working relationships with investigators and study staff, showcasing Caribou's high quality and ethical standards

Requirements:

• Bachelor’s Degree is required, in a science or a health-related field
• A minimum of 8 years of global clinical trial management experience within the pharmaceutical or biotechnology industry
• Early phase oncology focus is key, preferably within the hematology space
• In-depth understanding and experience across clinical operations with a track record of success in CRO and vendor delivery oversight
• Being a key contributor to study planning, execution, data cleaning, database locking, study report generation and regulatory inspection
• Experience with developing protocols, SOPs, Clinical Study Reports, INDs, NDAs, as well as other clinical, regulatory, and safety documents preferred
• Ability to lead cross functional study teams in a dynamic, evolving organization
• Excellent communication and interpersonal skills, with the ability to lead and motivate teams and collaborate effectively across functions (internally and externally)

Nice-to-Haves:

• Prior experience in the CAR-T space, with a specific focus in hematology
• An emphasis on inspection readiness for Clinical Operations
• Ease and confidence in being Investigator and site-facing

Caribou compensation and benefits include:

• Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employees
• Salary Range: $200,000 to $245,000 - 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 and floating 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, 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.