San Diego, CA
We are looking for a Senior level Clinical Scientist to join our team and provide scientific oversight to assigned clinical trials including protocol development, scientific support during study conduct and interpretation of results. We are looking for a passionate professional to provide broad scientific and/or medical input to strategic activities across the company’s matrix environment including: clinical development, medical affairs, regulatory and commercial. This candidate will also represent clinical research at internal and external forums, be the key point of contact for scientifically-based initiatives and serve as broad scientific/medical consultant to Clinical Development, Regulatory, and Medical Affairs activities.
Provide scientific input to clinical research activities, including protocol development, study implementation, analysis and reporting of results.
Contribute to the strategic planning, authoring, and review of regulatory submissions and scientific data disclosures.
Provide scientific expertise and support to externally facing groups, including the field medical team, medical information, and the commercial organization.
Present scientific information internally and externally.
Support all scientific aspects of clinical trial(s) and program level activities as assigned, providing scientific expertise to study protocols, case report forms, statistical analysis plans, interpretation of results, clinical study reports, graphical displays.
Scientific oversight and cleaning of key data for ongoing clinical trials throughout conduct.
Scientific support of regulatory documents including annual reports, investigators’ brochures, briefing books, safety updates, IND/NDA submission documents, and responses to regulatory authority questions.
Generate scientific slide decks based on clinical trials; Generate data presentations for clinical study reports and regulatory submissions.
General data compilation, interpretation, and communication; Conduct literature searches in support of scientific topics.
Provide quality control support as needed including clinical and regulatory documents, and slide decks.
Support development of specific scientific topics of interest such as those for discussion at advisory boards (generate slide decks, conduct ad hoc data analyses, perform literature reviews).
Provide scientific expertise and support to externally facing groups: Contribute to medical information letters, FAQs, and external training materials, generate scientific slide decks for field medical team, generate data presentations for commercial documents.
Scientific support of scientific data disclosures (manuscripts, abstracts, conference posters).
Other duties as assigned.
Master’s degree in a scientific discipline with 2-5 years of prior experience; PharmD., M.D. or Ph.D. in a related field with 2 years of experience preferred.
Medical writing experience helpful.
Previous experience in hepatology or related field, preferred.
Knowledge of GCPs, ICH guidelines and FDA regulations and familiarity with EMA/CHMP regulations and guidelines, and other international regulatory requirements.
General familiarity with biostatistics; expert in navigating scientific literature, interpretation of data, display of data.
Highly proficient in standard computer software (Word, Excel and Power Point).
Ability to travel, in some cases, internationally. (Average travel expectations: <20%/year.)