Caribou Biosciences
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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
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)
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.
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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
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)
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.
Referrals increase your chances of interviewing at Caribou Biosciences by 2x
Get notified about new Medical Director jobs in
Berkeley, CA .
#J-18808-Ljbffr