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Clinical Development Director
hace 2 meses
Position Overview
The Associate Director, Clinical Development Science provides clinical development expertise to a multi-disciplinary team engaged in advising clients in early through late-stage development of medical products.
Key Responsibilities
- Contribute to the design and conduct of clinical trials, including protocol development and implementation, statistical analysis plans, and data interpretation.
- Act as a clinical science liaison to establish relationships with key opinion leaders and principal investigators to provide enhanced peer-to-peer clinical/medical support.
- Support the development of clinical trial proposals, including research and analysis to summarize epidemiology, standard-of-care, and competitive environment.
- Develop and optimize clinical trial protocol synopses and full Phase I-IV clinical trial protocols.
- Build clinical development plans and strategic program assessments.
- Coordinate key opinion leader advisory boards.
- Contribute to clinical trial feasibility assessments and provide competitive intelligence support for the request for proposal process.
- Support for Pre-IND, IND, NDA/BLA, and other US regulatory submissions.
- Support for global regulatory submissions.
Requirements
- MD, PhD, PharmD, or equivalent in a scientific discipline or related field.
- Expertise and experience with the conduct of global clinical trials for medical products.
- 6+ years of experience in a clinical research setting, such as biotech/pharmaceutical industry, academia, government, and/or non-profit.
- Deep experience in Neuroscience/Ophthalmology or Immunology/Rheumatology/Inflammation with the ability to cross-cover in additional therapeutic areas.
- Familiarity with the operational conduct of global clinical trials, GCP/IHC, FDA, and other regulatory guidelines.
- Excellent interpersonal and communication skills, strong attention to detail, good organizational, prioritization, and time management skills.
- Ability to work on multiple projects simultaneously and navigate scientific literature, interpretation of data, and display of data.
