Head of Clinical Development

The Head of Clinical Development is a senior member of the R&D Leadership team responsible for supporting the strategy for and assuring clinical development of new products and lifecycle management endeavors.

Requirements

• In-depth understanding of the drug mechanisms PK and PD and therapeutic landscape
• Lead portfolio efforts in the design of Phases I through IV clinical programs
• Maintain a comprehensive understanding of the current and emerging practices and approaches to clinical development in the pharmaceutical and biotechnology industry
• Manage, develop, and hire personnel that design optimal clinical development plans and protocols for Phases I through IV activities
• Participate in the Protocol Approval Committee
• Serve as a member of the Safety Review Board
• Work seamlessly with Clinical Operations
• Consult with commercial, business development and scientific leaders to determine needs and requirements for clinical research
• Expansion of Product Pipeline and Portfolio
• Participate in the development of the strategic plan for acquisition and clinical development of new products in the Company’s pipeline
• Maintain a broad understanding of the strategic direction of the overall business and the key functional areas that are critical to Clinical Development
• Collaborate with other members of R&D to determine overall strategy including pipeline requirements portfolio development, product life-cycle management, competitive issues, environmental trends, Participate in due diligence activities for potential project/product acquisitions
• Regulatory Submissions and Interactions
• Collaborate with other members of R&D to determine overall strategy including pipeline requirements portfolio development, product life-cycle management, competitive issues, environmental trends, Participate in due diligence activities for potential project/product acquisitions
• Lead the clinical contribution to regulatory filings (IND, BLA, NDAs, sNDAs, etc.) for approval of new drugs, new indications, or revision of product labeling
• Expertise in GCP, ICH guidelines and ethical considerations
• Skills in preparing clinical study reports
• Handle and respond to information requests from regulatory agencies
• Contribute clinical information to annual NDA reports, annual IND reports, investigator brochures, and other submissions to regulatory agencies

Benefits

• Total Rewards package
• Competitive pay
• Benefits
• Well-Being