Senior Director of Clinical Operation

Position Overview :

The job holder is responsible for the leadership and oversight of development and implementation of clinical programs and pull-through projects. This position involves providing strategic insights for the company's assets, programs, and database development, collaborating closely with clinical, business development, and other relevant departments. This role offers leadership and strategic guidance across all phases of clinical trials, undertaking responsibilities for operational planning and resource management. Additionally, this person manages interactions with vendors and countries, demonstrating strong people management skills as a team leader. This individual serves as a scientific liaison between agencies, academic institutions, the pharmaceutical industry, and the company, acting as a representative in external engagements. Proactive risk management and adept contingency planning are integral aspects of this role.

Responsibilities :

• Provides strategic guidance for the planning, design, development, and interpretation of global clinical trials and research.
• Develops scientific approaches for clinical protocols and oversees related data collection activities, offering direction on global clinical trials as needed.
• Ensures optimal allocation of resources across trials to align with business needs based on portfolio prioritization.
• Takes the lead in developing global clinical trial protocols by collaborating closely with respective teams, translating approved trial concept sheets into efficient, high-quality, and executable clinical protocols.
• Manages the interface with vendors and countries, ensuring adherence to quality standards and contributing to the development / amendment of vendor contracts.
• Reviews and / or prepares strategic input for reports submitted to the FDA and other regulatory agencies.
• Contributes to internal publication strategies through paper proposals, scientific writing, and / or review.
• Implements the strategic plan for clinical projects, covering database monitoring, trial results, clinical case and statistical evaluation, and population management to support clinical operations.
• Develops and nurtures relationships with academic institutions for goodwill, business, and research collaboration.
• Actively participates in strategic planning at the corporate level.
• Supports corporate counsel in risk management and contract evaluation, demonstrating proactive management of risks and contingency planning skills.

Requirement :