Job 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.
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 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 research scientist team supporting clinical trials and overseeing CROs and other vendors
- Building reliable relationship with clinical investigators, discussing trial design, leading investigator’s meetings and advisory boards
- Monitoring safety and reporting adverse events
- Coordinating and developing information for reports submitted to the FDA 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
- Adhere 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 laws
Qualifications:
- MD degree or equivalent
- Hematology expertise
- Prior experience in cell therapy products
- 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
Nice-to-haves:
- 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
- Experience working in a Biotechnology Company
Caribou compensation and benefits include:
- Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employees
- Salary Range: $300,000 - $315,000. 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, 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.
