Director – Clinical Development

RegenIntel Bioscience, Inc – Job Location: Brea, CA

RegenIntel Bioscience, Inc has an immediate need to hire a Director – Clinical Development.

Desired Skills and Experience

The Director in Clinical Development will play a key role in the IND application and lifecycle management, and managing clinical trials. As a key employee, the candidate will enjoy the opportunity to be involved in every aspect of the drug product development process, and contribute to the company’s worldwide business development ventures.

This key role will manage all aspects of clinical trials (Phase I-III), plan, and execute clinical studies, including creating and managing study timelines, budgets, and project management plans in a fully out-sourced model. Additionally, she/he will provide guidance and shar learning across teams throughout planning and implementation, as well as ensure clinical operational and development deliverables and timelines are met across the development program(s).

Essential Duties and Responsibilities:

• Lead the evaluation, selection and management of Contract Research Organizations (CROs) and other external vendors to ensure successful clinical trial implementation and execution
• Create, manage, and execute all aspects of clinical operations programs, including but not limited to study management, budget, and Gantt timeline creation in MS Project
• Liaise with clinical site staff and Investigators to ensure optimal Sponsor-site relationships
• Draft/Review study protocols, ICFs and other relevant clinical documents as necessary
• Manage all aspects of study progress from planning to close-out to ensure timeline adherence and achievement of study goals while ensuring quality and data integrity in accordance with FDA, GCP, and ICH guidelines
• Lead, plan, and execute clinical Investigator meetings, study meetings and vendor meetings
• Contribute to Clinical Operations initiatives/programs including identifying areas of best practices and recommend process improvements, development of SOPs, risk management planning etc.
• Contribute in drafting documents for regulatory filings for INDs, NDAs; study reports, annual reports, and other documents for submission to relevant regulatory agencies as needed
• Ensure all clinical staff is adequately trained on company SOPs, GCP, FDA regulations and study related protocol and procedures

Experience, Education, Knowledge and Skills

• BS in a scientific or relevant healthcare discipline required; MS or Advanced degree preferred
• 8 years clinical drug development experience or a combination of education and relevant work experience in the pharmaceutical/biotech industry; Previous project management experience, u and well conversant in overall drug development from pre-IND through NDA required; Demonstrated knowledge of FDA regulations and ICH/GCP guidelines required; Experience monitoring clinical studies and conducting PSVs, SIVs, IMVs, and COVs; Experience in supervision and training of clinical operations staff and team leaders
• Excellent oral, written communication skills required, lead in a collaborative team environment

To apply, please send your CV to info@regenintel.com.