An opportunity has just emerged with a leading global Pharmaceutical company. This company focuses on improving outcomes for patients with rare and autoimmune diseases but has products in numerous therapeutic areas. This position’s primary role is to effectively and efficiently execute late phase clinical trials. As a technical or functional lead for the project team, this position plays a large leadership role within the organization. This position acts as Medical/Clinical sciences lead and holds the responsibility for developing and executing the Clinical Development Plan.
- Provides scientific leadership across multi-functional project teams and acts as the key clinical research representative for products that are in development at strategic meetings/advisory boards
- Uses, provides, and transfers technical and medical knowledge across teams to support the clinical study team and investigators.
- Acts as an expert within the clinical development process especially in phase II and phase III trials.
- Generates, executes, and preserves the project CDP and other clinical documents that remain consistent with the project goals
- Reviews study documents like study protocol, CRFs, SAPs, etc.
Supports clinical study and operational teams in developing, providing, and delivering high quality medical service and administrative study protocols
- Assists in identifying additional opportunities within the R&D portfolio
- U.S. licensed Medical Doctor MD or an MD equivalent degree is required
- 10+ years of late phase (phase II or III) Clinical Development experience from working for a pharmaceutical, biotechnology, or CRO company
- Strong knowledge and understanding of GCP, Clinical Research, Fundamentals of Project Management, working in matrix-based environment is required
- Leadership skills within managing multiple people and multiple projects
- Strong analytical, planning, medical/scientific writing skills required
- Experience in IND filing