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Associate Medical Director – Clinical Science – GI Tau
| Company | Takeda |
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| Location | Cambridge, MA, USA |
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| Salary | $194800 – $306130 |
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| Type | Full-Time |
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| Degrees | MD |
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| Experience Level | Senior |
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Requirements
- MD or internationally recognized equivalent plus 5 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of aforementioned)
- Previous experience successfully leading matrix teams
- Superior communication, strategic, interpersonal and negotiating skills
- Ability to proactively predict issues and solve problems
- Ability to drive decision-making within multi-disciplinary, multi-regional, matrix teams
- Diplomacy and positive influencing abilities
- Knowledge of regional/global Regulatory requirements
- Knowledge of GCP/ICH
Responsibilities
- Leads clinical teams as Global Clinical Lead or represents Clinical Science on Project and Clinical teams
- Supports the Global Project Team to ensure that the clinical team activities are aligned with the global strategy
- Contributes to the overall Asset Strategy by leading generation of the Clinical Development Plan, Clinical Protocols and other documents needed for CDP and study execution and regulatory submissions
- 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
- Oversees all Clinical Science activities relating to the preparation / approval of Synopses, Protocols and the conduct of clinical studies
- Responsible for or overseeing medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety
- Directs interactions with key opinion leaders relevant to assigned compounds and therapeutic area
- Responsible for evaluation of potential business development opportunities and conduct of due diligence evaluations assessing scientific, medical and development feasibility
- Interacts with research division and other functions based on pertinent clinical and development expertise to provide knowledge / understanding of market environment
Preferred Qualifications
No preferred qualifications provided.
