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Associate Director of Clinical Science Development
hace 2 meses
The Associate Director, Clinical Development Science provides clinical development expertise into a multi-disciplinary team engaged in advising clients in early through late-stage development of medical products.
Key Responsibilities- Protocol Development and Implementation: Contribute to the design and conduct of clinical trials, including protocol development and implementation, statistical analysis plans, and data interpretation.
- Clinical Science Liaison: Act as a clinical science liaison as a member of core study teams, establishing relationships with key opinion leaders and principal investigators to provide enhanced peer-to-peer clinical/medical support.
- Project Management: Support the PPD clinical trial proposal process, providing research and analysis to summarize the epidemiology, standard-of-care, and competitive environment for given opportunities.
- Team Collaboration: Work with a cross-functional consulting team, including experts in clinical development strategy, clinical research, regulatory strategy, CMC, and toxicology strategy.
- Deliverables: Develop, design, and optimize clinical trial protocol synopses and full Phase I-IV clinical trial protocols, and contribute to clinical trial scientific deliverables.
- Education: MD, PhD, PharmD, or equivalent in a scientific discipline or related field.
- Experience: 6+ years of experience in a clinical research setting, such as biotech/pharmaceutical industry, academia, government, and/or non-profit.
- Skills: Expertise in clinical trial design, conduct, and management, with strong knowledge of GCP, FDA, and other regulatory guidelines.
- Therapeutic Areas: Deep experience in Neuroscience/Ophthalmology or Immunology/Rheumatology/Inflammation, with the ability to cross-cover in additional therapeutic areas.
