We are seeking a Senior / Executive Director of Clinical Development to join our growing Clinical Development group. The ideal candidate 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. This position reports to Chief Medical Officer and can be based at the Company offices in Berkeley, California or remote.
Responsibilities will include:
Leading the direction, planning, execution of clinical trials and interpretation of clinical trials/research 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 team supporting clinical trials and overseeing CROs and other vendors
Recruiting clinical investigators at multiple sites and negotiating study design and costs
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 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 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.
Traveling up to 25%, both domestic and international
MD degree or equivalent
Experience in oncology/hematology or immunology in a pharma or biotech (prior experience of 5 years for Sr Director and 8 years for Executive Director position).
Prior experience in cell therapy products in a pharma or biotech setting is a must.
Experience in clinical trial planning and implementation in pharma or biotech
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
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, clinical operations, PK
Managing multiple programs simultaneously
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.