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 pioneers the development of treatments with small interfering RNAs and monoclonal antibodies and oversees 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’re changing lives for a living. Are you ready to make a difference?
The Position
The International Medical Director serves as a subject matter expert for our products and related data within a therapeutic area. The International Medical Director is a team player, detail-oriented with prior research experience, either in academia or industry. In this role, the International Medical Director helps develop products within the Novel Modalities team working with the ATTR cardiomyopathy project. In doing so, 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. The International Medical Director will also assist the Sr. Medical Director in the development and execution of strategic priorities within the therapeutic area, helping develop PRO and biomarker strategies.
Relationships
Reports to: Senior Director of Novel Modalities
Work with the VP Medical/Scientific Development, 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 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 provide medical monitoring of ongoing clinical trials.
Physical Requirements
10-20% overnight travel required.
Qualifications
- MD or the international equivalent is required.
- 1+ years Pharmaceutical/Biotech industry experience, including time managing clinical trials, or academic clinical research background.
- Experience within the cardiovascular therapy area is preferred.
- Experience with clinical development from the pharmaceutical industry or biotech industry is preferred.
- Strong scientific background with experience in reviewing & interpreting scientific and study data is required.
- Track record of scientific publications strongly preferred.
- Working knowledge of biostatistics, data management, clinical operations and scientific and technical processes desirable.
- Working knowledge of the drug development process.
- Team player who works collaboratively in a challenging team matrix environment.
- Ability to work independently to resolve challenges and conflicts.
- Excellent written and oral communication skills.
- Integrity, honesty and highest ethical standards and a sense of personal accountability.
- Quickly adapt and provide innovative solutions to challenges as they present themselves.
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