Gemma Odena, Ph.D. Email & Phone Number

Raleigh, 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 III) 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.

Raleigh, Nc, Us

• Providing scientific and strategic input and authoring high-quality clinical documents including clinical study outlines, protocols, and CSRs for Class IIb and Class III medical devices. Contributing to study design, endpoint selection, analysis and interpretation of scientific, clinical, and statistical data. Working closely with Biometrics to anticipate necessary analyses and data tables for optimal presentation of results. • Writing support and scientific input for several other clinical and regulatory documents, including IFUs, SAPs, electronic patient diaries, eCRFs, investigator brochures (IB), and ICFs. • Developing appropriate key messaging and driving document preparation process within teams, ensuring scientific accuracy and internal consistency, and leading document review meetings with stakeholders to achieve consensus on document strategy and content.• Mentoring junior Medical Writing team members and coaching on complex projects, as necessary. Program forecasting and support to Medical Writing management in resource planning. • Reviewing selected documents from staff, contractors, or CROs with focus on internal standards, ICH guidelines, as well as organization of content, clarity of text and tables, overall consistency, and appropriate use of English language. • Serving as subject matter expert representing Medical Writing on cross-functional teams and participating in the development of Best Practices, SOPs, templates, and style guides to improve document quality.

Raleigh, Nc, Us

• Provided scientific support to Medical Affairs and Medical Departments in the pharmaceutical industry or the healthcare sector. Therapeutic areas included oncology, pain medicine, hematology, dermatology, cardiology, virology, immunology, nephrology, gynecology, and ophthalmology.• Medical writing support for 12 scientific manuscripts, 3 protocols, 2 reports and a drug monograph. Facilitated and provided minutes of 4 scientific meetings.• Edited 10 manuscripts, advised on publication planning and coordinated submission of 17 manuscripts and provided support with peer-reviewed comments.

• Scientific support and science communications in the healthcare sector, drafting clinical protocols and performing literature reviews, supporting 8 manuscripts. Edited and proofread over 50 manuscripts and abstracts. Provided publication support for 6 manuscripts.• Covered 2 conferences and authored 2 advisory board meeting minutes. Compiled 14 slide kits and provided written tests for 5 CME online classes.

Chapel Hill, Nc, Us

• Clinical translational research focused on the development of new therapies for alcoholic liver disease performing investigations to identify molecular determinants of alcoholic hepatitis resulting in 13 publications. Wrote and reviewed 2 grants, progress reports, 4 IRB protocols and 2 IACUC protocols.• Independently managed 2 projects and served as site manager of an international collaborative NIH-funded international consortium. Wrote scientific reports, compiled site budgets, complied with internal and external deadlines, and promoted consortium in international meetings.• Recruited and trained 2 scientist and 4 support staff and mentored 2 undergraduate students.

• Research focused on the development of strategies to address complications of advanced liver diseases with a focus on bacterial translocation and encephalopathy resulting in 7 publications

Management of experimental animals. Development of cirrhosis in a rat model as well as optimization of several techniques of molecular biology.

Doctor Of Philosophy (Phd), Biology

Bachelor'S Degree, Biology/Biological Sciences, General