Caribou Biosciences is hiring a
Medical Director

Summary

Join our Clinical Development team as a Medical Director and lead the direction, planning, execution of clinical trials and interpretation of clinical trials/research data. Establish scientific methods for design, implementation of clinical protocols, and ensure trial subject safety.

Requirements

• MD degree or equivalent
• Hematology expertise
• Experience in clinical trial planning and implementation
• Experience or exposure to FDA/EMA/PMDA/ or other regulatory agencies interactions
• Excellent verbal and written communication skills
• Contributing to the Clinical Strategy and Clinical Development Plans for the Company’s assets
• Proven ability to work independently, as well as to collaborate with peers and work effectively in a fast-paced team-oriented environment
• Strong organizational, time management, communication, and interpersonal skills
• Capable of managing multiple diverse projects simultaneously
• This role must be based in a pre-registered state (CA, WA, AZ, FL, GA, IL, MA, MN, NJ, NC, TX, VA, NY, CO, OR)

Responsibilities

• Leading the direction, planning, execution of clinical trials and interpretation of clinical trials/research data
• Establishing scientific methods for design, implementation of clinical protocols, and ensuring trial subject safety
• Leading clinical trials, phases I - IV, for company products under development
• Building and managing the Clinical team supporting clinical trials and overseeing CROs and other vendors
• Building reliable relationship with clinical investigators, discussing study design, leading study investigator’s meetings
• Monitoring safety and reporting adverse events
• Coordinating and developing information for reports submitted to the Food and Drug Administration and other health authorities and representing the Company at different forums
• Monitoring adherence to protocols and determining study completion
• Reviewing clinical data and leading/authoring reports and study related documents, such as IBs, study protocols, publications and regulatory filings including briefing documents, reports, and IND/BLA submissions
• Evaluating products for in/out-licensing
• Participating in cross-functional teams, working in a highly matrixed team environment to advance preclinical programs to clinical evaluation
• Staying abreast on the clinical development and regulatory issues related to other competitive or relevant compounds in development and providing recommendations on changes needed to our strategy or clinical development plan as a result
• Provide medical review, assessment and interpretation of clinical data reported in clinical study reports to ensure that the data are correct and presented with the appropriate medical interpretation

Preferred Qualifications

• Prior experience in cell therapy products
• Experience with product launch activities including authoring of BLA or MAA
• Knowledge of current best practices for potency assays for cellular therapies
• Background in immuno-oncology or cell engineering

Benefits

• Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employees
• Salary Range: $280,000 to $300,000. 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