Clinical Development Director
hace 2 semanas
The Associate Clinical Science Development Director will provide clinical development expertise to a multi-disciplinary team advising clients in early through late-stage development of medical products. This role will contribute to the design and conduct of clinical trials, including protocol development and implementation, statistical analysis plans, and data interpretation. The successful candidate will also act as a clinical science liaison, establishing relationships with key opinion leaders and principal investigators to enhance peer-to-peer clinical/medical support and prioritize trial recruitment and quality delivery.
Key Responsibilities
- Develop, design, and optimize clinical trial protocol synopses and full Phase I-IV clinical trial protocols.
- Clinical science liaison activities, including supporting key opinion leaders, principal investigators, 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.
Requirements
- 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.
- 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 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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