Senior International Medical Director

About the Department

Our East Coast Global Development Hub brings together the best minds in life science innovation with facilities in Lexington, MA and Plainsboro, NJ. Our Novel Modalities department pioneer’s development of treatments with small interfering RNAs and monoclonal antibodies and oversee a robust pipeline of projects from early research through late-stage clinical development. We are building a multi-talented team of physician scientist drug developers that works together to tackle key challenges and opportunities in drug development to improve the lives of people with disease. We are building for the future, creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple innovative modalities. Our East Coast Global Development Hub merges biotech speed and agility with large pharmaceutical company quality, resources, and stability, uniting the best of both worlds to develop new medicines for patients. We recognize that improving human health starts here and that patients rely on us. We’re changing lives for a living. Are you ready to make a difference?

The Position

The Senior International Medical Director serves as a subject matter expert for our products and related data within a therapeutic area. The Senior International Medical Director is a team player, detail oriented with prior research experience, either in academia or industry. In this role, the Senior International Medical Director helps develop products within the Novel Modalities team as the medical lead of the ATTR cardiomyopathy project. In doing so, the Senior 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. The Senior International Medical Director will also take medical lead in the development and execution of strategic priorities within the therapeutic area, help develop PRO and biomarker strategies.

 

Relationships

Reports to: Senior Director of the Novel Modalities department  Work with the Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams.

Will be interfacing with both internal and external stakeholders including KOLs and Principal Investigators.

 

Essential Functions

• 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 Saf