Clinical Scientist, GI2 TAU
Core
Leads clinical science for US/EU development of Takeda pipeline compounds, influencing development plans and protocols to achieve regulatory approval.
Role type
Senior IC clinical scientist (pharmaceutical development)
Builds
Clinical development plans, protocols, and regulatory submission materials
Domain
Pharmaceutical industry, Gastroenterology (GI)
Required skills
Clinical development strategy, protocol design, regulatory affairs knowledge, data interpretation, cross-functional leadership, stakeholder management, budget management, safety monitoring, KOL engagement
Preferred skills
Therapeutic area expertise, GCP/ICH compliance, strategic planning
Technologies
Clinical trial management systems, statistical analysis tools
Responsibilities
Lead multi-disciplinary teams to align US/EU activities with global strategy; Develop and maintain clinical development plans and protocols; Interpret study data to inform go/no-go decisions; Manage medical monitoring and safety information; Engage with regulatory authorities and key opinion leaders.
Seniority
Senior, hands-on IC with strategic influence