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Z-426 - Associate Clinical Science Development Director, Emea
hace 2 meses
Detalles del empleo
Tipo de empleo:
- Jornada completa
Turno y horario:
- De lunes a viernes
Ubicación:
Barcelona, Barcelona provincia
Descripción completa del empleo
Job Description
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. Input 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/medical 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 include:
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 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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