Vice President/Senior Vice President of Clinical Development

We are seeking a Vice President/ Senior Vice President 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, and 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 include:

Leading the direction, planning, execution of clinical trials and interpretation of clinical trials/research data globally
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
Overseeing and contributing to the clinical and scientific background sections of various documents, including Study Protocols, Investigator’s Brochures, INDs, CTAs, Study Reports, Clinical Summaries, Clinical Overviews, and other documents
Reviewing and approving clinical documents, including protocols, annual reports, final study reports, IB, CRFs and other documents as needed
Representing the company’s clinical programs to regulators, key opinion leaders, and cross functional partners as needed
Evaluating potential study sites and investigators from a scientific/strategic perspective and assist in the conduct of study site initiation visits (preparation, personnel training, etc.) and investigator meetings
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
Providing 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
Adhering 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).
Ensuring consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations and laws.
Traveling up to 25%, both domestic and international
Qualifications:

MD degree or equivalent medical degree
Prior experience of 10+ years for Vice President or 15+ years for Senior Vice President position in oncology/hematology Clinical Development in the pharmaceutical/biotech industry.
Prior experience in cell therapy products in a pharma or biotech setting is a must.
Experience interacting with regulatory agencies. Prior IND/IMPD/NDA/BLA experience is a must.
Experience in designing/managing all phases of Oncology Drug Development, including the understanding and proven track record meeting applicable regulatory, quality and compliance standards
Experience with FDA/EMA/PMDA/ or other regulatory agencies interactions is a must.
Excellent verbal and written communication skills
Experience developing Clinical Strategy and Clinical Development Plans for the company’s assets in alignment with senior management
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
Some experience working in a small biotech organization is desired.
Experience interacting with CMO/CRO partnerships
Background in immunology, gene editing or immune cell product evaluation clinically
Up to date knowledge of biostatistics, clinical operations, PK, PD, and biomarkers.
Managing multiple programs simultaneously
Track record of building and establishing clinical development teams
A “hands-on”, “roll-up-the-sleeves” when necessary, leader that understands the need for involvement within a small company environment while recognizing when to delegate and seek results from the team
Flexibility and ability to respond to rapidly changing environments and circumstances
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, including a booster shot, 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.

To apply for this job please visit boards.greenhouse.io.

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