International Medical Director
4 weeks ago
The International Medical Director will serve as a subject matter expert for our products and related data within a therapeutic area. This role requires a team player with prior research experience, either in academia or industry, to develop products within the Novel Modalities team working with the ATTR cardiomyopathy project. The International Medical Director will work across different functional teams to support the design and execution of clinical trials, the drafting of medical/scientific documents, safety monitoring, and data analyses. Additionally, the International Medical Director will assist the Sr. Medical Director in the development and execution of strategic priorities within the therapeutic area, help develop PRO and biomarker strategies.
Key Responsibilities
- Support the Novel Modalities team as a drug-developer for assigned programs to both internally and externally facing stakeholders
- Provide clinical and scientific expertise to the design of studies, writing of protocols and other study and regulatory-related documents
- Participate in the analysis and interpretation of data, ensure integrity of trial data, and assist in reporting of study results including preparation of scientific summaries, abstracts and manuscripts
- Provide leadership in the execution of clinical trials
- Ensure compliance with SOPs, ICH, GCP and other national and international regulatory requirements
- Work with Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams to deliver and drive the timely completion of all clinical activities related to emerging clinical-stage programs
- Serve as a leading member, or participant, at multiple internal review groups and utilize novel and creative methods to resolve clinical development problems
- Work with the larger Global Project Team to deliver excellent medical support for clinical-stage programs
- Interface with US/international regulatory authorities, as appropriate, in support of the development objectives for the and assist Regulatory Strategy staff in the compilation of submissions and in the responses to inquiries
- Lend clinical expertise to the Statistical Analysis Plan development and data management, and work closely with statistical programming and data management on the project level
- Act as a liaison between the company and clinical site investigators and KOLs
- Interface with Safety Review Committees and Data Safety Monitoring Committees
- Participate in safety review meetings and providing medical monitoring of ongoing clinical trials
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International Medical Director
4 weeks ago
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