Director - Clinical Development

4 weeks ago

Brea, United States RegenIntel Bioscience Full time

**RegenIntel Bioscience, Inc - Job Location: Brea, CA**

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

**Desired Skills and Experience**

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

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