Serve as broad scientific/medical consultant to Clinical Development, Regulatory, and Medical Affairs activities; Provide scientific support of Commercial initiatives.
To perform this job successfully an individual must be able to perform each essential function satisfactorily.
• 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.
• A Master’s degree in a scientific discipline; Pharm D., M.D. or Ph.D. in a related field preferred. Pharm D., M.D. or Ph.D.: None to two years experience working in biotech/pharmaceutical industry preferred; two to five years prior experience for Master’s degree.
• Must have experience working in protocol development and data analysis in Phase 1- Phase 3 clinical trials.
• Medical writing experience helpful.
• Previous experience in hepatology or related field, preferred.
REQUIRED KNOWLEDGE AND ABILITIES:
• Knowledge of GCPs, ICH guidelines and FDA regulations and familiarity with EMA/CHMP regulations and guidelines, and other international regulatory requirements.
• Strong interpersonal and communication skills; proactive approach. Able to work both independently and in a team environment.
• Detail-oriented, with good organizational, prioritization, and time management proficiencies. Must be able to work on multiple projects simultaneously.
• General familiarity with biostatistics; expert in navigating scientific literature, interpretation of data, display of data.
• Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures.
• Highly proficient in standard computer software (Word, Excel and Power Point).
• Ability to travel, in some cases, internationally. (Average travel expectations: <20%/year.)