**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Position Overview**
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. Inpout will be provided into the design and conduct of clinical trials, e.g., through contributing to protocol development and implementation, development of statistical analysis plans and interpretation of data and generation of clinical study reports. The Associate Director, Clinical Development Science will act as a clinical science liaison as a member of core study teams responsible for establishing relationships with KOLs/PIs to provide enhanced peer-to-peer clinical/medial support enabling prioritization of trial recruitment and quality trial delivery and addressing scientific trial queries while also supporting the PPD clinical trial proposal process to provide research and analysis to summarize the epidemiology, standard-of-care and competitive environment for the given opportunity.
**Duties and Responsibilities**
Strong teamwork skills required to work with a cross-functional consulting team (e.g., experts in clinical development strategy, clinical research, regulatory strategy, CMC and toxicology strategy, biostatistics, clinical pharmacology and pharmacokinetics). In addition, this role will be involved in projects in partnership with clinical trials teams, who will provide additional training and guidance. Responsibilities, including:
- 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 of 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 (e.g., basket trials, umbrella trials, adaptive designs, master protocols, decentralized trials, pragmatic trials)
- 6 + years of expereience (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 integral 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)