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Associate Clinical Science Development Director, EMEA

3 mesi fa

Rome, Italia ThermoFisher A tempo pieno
Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionPosition OverviewThe 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 ResponsibilitiesStrong 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 protocolsClinical 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 assessmentsCoordinate of key opinion leader advisory boardsContribute to clinical trial feasibility assessmentsProvide competitive intelligence support for the request for proposal processProvide clinical strategy into health authority briefing packagesSupport for Pre-IND, IND, NDA/BLA and other US regulatory submissionsSupport for global regulatory submissionsEducation and ExperienceMD, PhD, PharmD, or equivalent in a scientific discipline or related field requiredExpertise and experience with the conduct of global clinical trials for medical products clinical training and/or experience strongly preferredSeeking 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 preferredFamiliarity with the operational conduct of global clinical trialsKnowledge of GCP/IHC, FDA and other regulatory guidelinesKnowledge of global requirements for regulatory approval and marketing of medical productsExcellent interpersonal and communication skillsStrong attention to detailGood organizational, prioritization and time management skillsAbility to work on multiple projects simultaneouslyGeneral familiarity with biostatistics and pharmacokineticsExpert in navigating scientific literature, interpretation of data and display of dataAbility to work both independently and in a team environmentHighly proficient in standard computer software (MS Word, Excel, PowerPoint)Job SummaryJob number: R-01256786Date posted : 2024-07-25Profession: Clinical ResearchEmployment type: Full time