Responsibilities
* Develop, design, and optimize clinical trial protocol synopses and full Phase I-IV clinical trial protocols
* Clinical science liaison activities including supporting KOLs, PIs and clinical trial sites.
* Contribute to clinical trial scientific deliverables by providing scientific review and input to key study documents ensuring scientific rigor, consistency, and alignment with strategy.
* Build clinical development plans and strategic program assessments
* Coordinate key opinion leader advisory boards
* Contribute to clinical trial feasibility assessments
* Provide competitive intelligence support for the request for proposal process
* Provide clinical strategy into health authority briefing packages
* Support for Pre-IND, IND, NDA / BLA and other US regulatory submissions
* Support for global regulatory submissions
Education and Experience
* MD, PhD, PharmD, or equivalent in a scientific discipline or related field required
* Expertise and experience with the conduct of global clinical trials for medical products; clinical training and/or experience strongly preferred
* Seeking an experienced professional with exceptional client-facing skills.
* Familiarity with various clinical trial designs, including more complex trials (basket trials, umbrella trials, adaptive designs, master protocols, decentralized trials, pragmatic trials)
* 6+ years of experience (following receipt of doctoral degree) 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 is strongly preferred
* Familiarity with the operational conduct of global clinical trials
* Knowledge of GCP/IHC, FDA, and other regulatory guidelines
* Knowledge of global requirements for regulatory approval and marketing of medical products
* Excellent interpersonal and communication skills
* Strong attention to detail
* Good organizational, prioritization, and time management skills
* Ability to work on multiple projects simultaneously
* General familiarity with biostatistics and pharmacokinetics
* Expert in navigating scientific literature, interpretation of data, and display of data
* Ability to work both independently and in a team environment
* Highly proficient in standard computer software (MS Word, Excel, PowerPoint)
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