Clinical Scientific Director

Position Objectives

Drives, or contributes to, strategy for clinical studies within the overall global clinical development for assigned Takeda pipeline compound(s) taking into consideration the medical, scientific, regulatory and commercial issues. Joins multi-disciplinary, multi-regional, matrix teams as they address, and take decision in, highly complex circumstances. Has the responsibility for development decisions assessing and integrating the input from various disciplines to create, maintain, and execute studies within a clinical development plan that will result in the regulatory approval of the compound in multiple regions.

Applies clinical decision making to clinical development issues. Interacts with and influences Neuroscience Therapeutic Area Unit and project or franchise leadership decision-making by contributing to strategic direction. Success or failure directly translates to the ability of R&D to meet its corporate goals and for Takeda to have future commercial products.

• Represents Clinical Science on Study Execution and Clinical Teams.
• Supports the Clinical Subteam to ensure that the clinical team activities are aligned with the global strategy.
• Contributes to Global Project and Clinical Subteam strategy and deliverables working on the Asset Strategy, Clinical Development Plan, Clinical Protocols and other documents needed for study execution.
• Recommends scope, complexity and size, and influences the budget of aspects of a study or program.
• Responsible for monitoring and interpreting data from ongoing internal and external studies, assessing the medical and scientific implications and making recommendations that impact regional and global development such as “go/no go” decisions or modification of development plans or study designs that may have a significant impact on timelines or product labeling.
• Ensures that at all times the scientific rigor and integrity of clinical trials are maintained, and that the resulting data are of high quality to allow data‑driven decision‑making.
• In this role works with, and leads, other functional representatives to ensure optimal data quality.
• Ongoing work output will involve continual critical evaluation of the development strategy to maintain a state‑of‑the‑art development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency plans to meet them.
• Recommends high impact global decisions.

• Oversees or contributes to Clinical Science activities relating to the preparation / approval of Synopses, Protocols and the conduct of clinical studies.
• Serves as an advisor to other clinical science personnel involved in these activities and contributes to the successful design and interpretation of clinical studies.
• Interprets data from an overall scientific standpoint as well as within the context of the clinical significance to individual patients.
• May present study conclusions to Management and determine how individual study results impact the overall compound strategy.

• Responsible for clinical data monitoring activities, assessing issues related to protocol conduct, data quality and integrity, and participant well‑being.
• Assesses overall safety information for studies and compound in conjunction with the study medical director and Pharmacovigilance.
• May oversee other clinical scientists with respect to assessment of these issues.
• Informs final decisions regarding study conduct related to scientific integrity.

• Contributes to or leads interactions with study investigators, key opinion leaders relevant to assigned studies, compounds and therapeutic area.
• Contributes to developing documents required to outline the Company positions on research programmes or regulatory applications (e.g. briefing or summary documents), materials used for meeting presentations, and formal responses to communications received from the regulatory authorities, IRBs/ECs, or opinion leaders.
• Leads or contributes to incorporation of advice / recommendations received into the…