We are seeking a Director of Clinical Research who will support clinical development strategy and plans. This leadership role is responsible for timely execution of First-in-Human programs through proof-of concept and delivery on clinical study designs, high quality trial execution, and preparation of clinical protocols. This role reports to the Senior Vice President of Clinical Development and will work with the Clinical Study Physician, Clinical Operations, and Biostatistics. This role may be remote or based in our offices in Berkeley, CA
Provide leadership, oversight, and management of clinical studies including planning, execution, completion, and reporting of clinical trials
Review and analyze clinical data and assist in generating study reports, publications, and regulatory documents
Conduct data review, analysis, and interpretation of clinical trials data
Follow safety and data review plans to perform and document regular review of patient safety data and perform review of cumulative safety data
Draft clinical and safety sections of critical documents, e.g., protocol amendments, investigator brochure, and regulatory documents including Investigator Brochures, Annual Reports, IND sections, Clinical Study Reports.
Prepare presentations regarding strategy and/or data and supports and assists in the development of publications, abstracts, and presentations.
Partner with Translational Science and Clinical Operations as needed to ensure compliance with GCP and quality execution of plans that involve patient samples and analysis.
Develop and maintain professional relationships with external stakeholders
Perform other duties as assigned related to clinical programs
PhD/PharmD and 4+ years; MA/MS/MSN and 7+ years; or BA/BS/BSN and 9+ years of experience in clinical development. Three of these years should be in a clinical type role with a track record executing oncology development programs to completion or targeted milestone.
Demonstrated experience in (and understanding of) oncology drug development especially in Early Development; familiarity with related disciplines (biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences)
Must have proven scientific writing skills and good communication skills
Demonstrated experience with GCP
Strong interpersonal skills and team partner with demonstrated ability to build consensus
Data listing review experience
Ability to work collaboratively in a fast-paced, team environment and to function independently as appropriate
Ability to perform complex data analysis
Work Schedule or Travel Requirements
Availability during normal business in the candidate’s time zone and availability regionally to meet with clinical study centers and California company meetings as needed
Caribou compensation and benefits include:
Comprehensive compensation package, which includes stock options and an employee stock purchase program for all employees
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
Tuition reimbursement program
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.
Caribou requires employees to be fully vaccinated against COVID-19 unless they have an approved medical or religious accommodation. Proof of such vaccination will be required as part of the hiring process.
For more information about Caribou, visit www.cariboubio.com and follow the company @CaribouBio.