Medical Director

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. 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.Our dedicated and collaborative Clinical Development team is seeking an innovative and highly motivated Medical Director. The Medical Director will establish, direct, and manage the clinical efforts and interact closely with senior management, other clinical team members, regulatory, process development, functional group leaders, scientists, and research associates to develop a clinical strategy for multiple pre-clinical programs. This hands-on role will involve design and execution of clinical trials.Responsibilities:Leading the direction, planning, execution of clinical trials and interpretation of clinical dataEstablishing scientific methods for design, implementation of clinical protocols, and ensuring trial subject safetyLeading clinical trials, phases I - IV, for company products under developmentBuilding and managing the clinical research scientist team supporting clinical trials and overseeing CROs and other vendorsBuilding reliable relationship with clinical investigators, discussing trial design, leading investigator’s meetings and advisory boardsMonitoring safety and reporting adverse eventsCoordinating and developing information for reports submitted to the FDA and other health authorities and representing the Company at different forumsMonitoring adherence to protocols and determining study completionReviewing 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 submissionsEvaluating products for in/out licensingParticipating in cross-functional teams, working in a highly matrixed team environment to advance preclinical programs to clinical evaluationStaying 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 resultProvide 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 interpretationAdhere to both Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) aligned with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH)Ensure consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations, and lawsQualifications:MD degree or equivalentHematology expertisePrior experience in cell therapy productsExperience in clinical trial planning and implementationExperience or exposure to FDA/EMA/PMDA/ or other regulatory agencies interactionsExcellent verbal and written communication skillsContributing to the Clinical Strategy and Clinical Development Plans for the Company’s assetsProven ability to work independently, as well as to collaborate with peers and work effectively in a fast-paced team-oriented environmentStrong organizational, time management, communication, and interpersonal skillsCapable of managing multiple diverse projects simultaneouslyNice-to-haves:Experience with product launch activities including authoring of BLA or MAAKnowledge of current best practices for potency assays for cellular therapiesBackground in immuno-oncology or cell engineeringExperience working in a Biotechnology CompanyCaribou compensation and benefits include:Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employeesSalary Range: $300,000 - $330,000. 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 holidaysExcellent medical, dental, and vision insurance401(k) retirement savings plan, which includes matching employer contributionsEmployee stock purchase plan (ESPP)Tuition reimbursement programThe 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.