About This Role
An Associate Medical Director in Clinical Science for the GI2 TAU team supports the global strategy of the project and clinical teams. This role involves developing clinical plans and protocols, interpreting study data, and making recommendations that impact global development. The position suits a medical professional with clinical research experience in the pharmaceutical industry.
Responsibilities
- Represent Clinical Science on Project or Clinical Teams and may serve as the Clinical Science leader on these teams
- Support the Global Project Team to ensure that clinical team activities are aligned with the global strategy
- Contribute to the overall Asset Strategy by supporting the development of the Clinical Development Plan
- Lead the development of Clinical Protocols and other documents needed for CDP and study execution and regulatory submissions
- Recommend scope, complexity, size, and influence the budget of all aspects of a study
- Continually critically evaluate the development strategy to maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements
- Proactively identify challenges and develop contingency plans to meet them
- Recommend high impact global decisions
- Monitor and interpret data from ongoing internal and external studies
- Assess medical and scientific implications and make recommendations that impact regional and global development such as “go/no go” decisions or modification of development plans or study designs
- Oversee Clinical Science department activities relating to the preparation/approval of Synopses, Protocols, and the conduct of clinical studies
- Serve as an advisor to other clinical scientists involved in these activities and be accountable for the successful design and interpretation of clinical studies
- Present study conclusions to Management and determine how individual study results impact the overall compound strategy
- Interpret data from an overall scientific standpoint as well as within the context of medical significance to individual patients
- Responsible for medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety
- Assess overall safety information for studies and compound in conjunction with Pharmacovigilance
- Oversee non-medical clinical scientists with respect to assessment of these issues
- Make final decisions regarding study conduct related to scientific integrity
- Direct interactions with key opinion leaders relevant to assigned compounds and therapeutic area
- Provide leadership in meetings and negotiations with key opinion leaders, establishment of strategy for assigned compounds, and the direction of clinical scientists involved in developing documents required to outline the Company positions on research programs or regulatory applications
