Caribou Biosciences

Caribou Biosciences, Inc. is a leading company in CRISPR genome engineering located in Berkeley, CA. Caribou's tools and technologies provide transformative capabilities to therapeutic development, agricultural biotechnology, industrial biotechnology, basic and applied biological research. The six-year-old company has developed a next-generation best-in-class CRISPR genome engineering technology platform and has a leading intellectual property position. 

We are seeking a Director of Clinical Development/Medical Director to lead our newly created Clinical Development group in Berkeley. The ideal candidate will establish, direct and manage the clinical efforts and interact closely with senior management, 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 will include:

• Overseeing the direction, planning, execution and interpretation of clinical trials/research and data collection activities 
• Establishing and approving scientific methods for design and implementation of clinical protocols, trial subject safety and efficacy data collection systems and final reports  
• Recruiting clinical investigators at multiple sites and negotiating study design and costs  
• Directing human clinical trials, phases I - IV, for company products under development
• Building and managing the Clinical Development department and overseeing CROs and staff
• 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 these forums 
• Monitoring adherence to protocols and determining study completion  
• Preparing relevant sections of IBs, study protocols, publications and regulatory filings including briefing documents, reports and 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
• Traveling up to 25%, both domestic and international

Candidate must possess:

• MD degree or equivalent
• Board certified oncologist/hematologist  
• Minimum of 5 years of experience in clinical trial planning and implementation in pharma or biotech
• Demonstrated experience with FDA/EMA/Health Canada requirements
• Excellent verbal and written communication skills
• 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 

Pluses:

• Experience working in a small biotech organization
• Experience interacting with CMO/CRO partnerships
• Background in immunology, gene editing or immune cell product evaluation clinically
• Working knowledge of biostatistics, clin ops, PK
• Managing multiple programs simultaneously

Caribou Biosciences, Inc. is a dynamic start-up company, and the successful candidate must have the ability and desire to work in a fast-paced environment.  For more information, please visit www.cariboubio.com.  Caribou is on Twitter.  Sign up to follow our Twitter feed @CaribouBio.

Caribou offers a comprehensive compensation package, as well as generous paid time off in addition to Company-observed holidays.  The Company provides medical, dental, and vision insurance, along with a 401(k)-retirement savings plan which includes matching employer contributions. Caribou promotes a culture in which employees are respected and rewarded for hard work, innovation, personal initiative and teamwork. 

Caribou is an equal opportunity employer and does not discriminate on the basis of race, color, religion, citizenship, political activity or affiliation, marital status, age, national origin, ancestry, physical or mental disability, medical condition (as defined under California law), veteran status, sexual orientation, gender identity, gender expression, sex or gender (which includes pregnancy, childbirth, breastfeeding, or related medical conditions), 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.