Gemma Odena

About Gemma Odena

Clinical and translational scientific expert with comprehensive experience in clinical development for Medical Devices (class II and and Drug programs. Passionate about health sciences, particularly about advancing and disseminating innovative therapies.My extensive scientific and clinical expertise comprises leading phase II, pilot, pivotal and post-approval clinical trials, authoring high-quality clinical documents including study outlines, clinical protocols, clinical study reports, clinical modules of regulatory documents, 23 scientific papers, 2 book chapters, IRB protocols, scientific reports, grants applications, posters, slide kits and editing over 50 manuscripts.You can find me at o••••••••@gmail.comLet\'s connect!

Experience

1. Associate Director, Clinical Development

   Merz Aesthetics

   Jul 2021 — Present · Raleigh-Durham-Chapel Hill, NC, US

   Lead scientific expert responsible for clinical trial design, protocol development, and report writing and approval for both US and ex-US (China) studies in Medical Devices (class II and and Drug Clinical Development.• Developing Clinical strategy and providing scientific advice to the Clinical and Regulatory teams on the scientific aspects of assigned studies (phase II, pilot, pivotal, and post-approval) leading to a successful PMA approval for a new indication. Contributing to the development of global regulatory strategies (clinical development plans, clinical components of target product profile and global development plan).• Authoring and leading the development of high-quality clinical documents (study outlines, clinical protocols - CSPs, clinical study reports - CSRs). Communicating a clear overview of trial results to program teams and leadership.• Providing organizational support for Advisory Boards, Investigator Meetings and Data Monitoring Committee.• Analyzing, reviewing, and interpreting clinical data, contributing to statistical analysis plans (SAPs), tables, figures and listings (TFLs), electronic case report forms (eCRF), and informed consent forms (ICF), conducting safety monitoring, and participating in study close-out and database lock activities. • Providing scientific expertise for clinical modules of FDA regulatory including briefing packages, investigational new drug application (IND), investigation device exemption (IDE), annual progress reports, premarket approval (PMA), instructions for use (IFU), and interactive review responses.• Authoring scientific publications, supporting external dissemination of clinical trial data through abstracts, posters, and presentations.

Education

• Universitat Autònoma de Barcelona

  Doctor of Philosophy (PhD), Biology

  2005 — 2011

• Universitat Autònoma de Barcelona

  Bachelor's degree, Biology/Biological Sciences, General

  1998 — 2003

Skills

• Polymerase Chain Reaction (Pcr)
• Animal Models
• Science
• Research
• Tissue Culture
• Grant Writing
• Microsoft Powerpoint
• Editing
• Problem Solving
• Biotechnology
• Stem Cells
• Mentoring
• Cell
• Scientific Writing
• Rna Isolation
• Biomarkers
• Life Sciences
• Immunohistochemistry
• Qpcr
• Writing
• Translational Research
• Scientific Analysis
• Medical Writing
• Microsoft Word
• Elisa
• Pcr
• Molecular Biology
• Microscopy
• Spss
• Public Speaking
• Cell Biology
• Flow Cytometry
• Data Analysis
• Cell Culture
• Project Management
• Clinical Research
• Microsoft Excel
• Western Blotting
• Western Blot
• Teamwork