Design innovative and feasible clinical trials in collaboration with clinical development team members. Regularly monitor, clean, analyze and review safety and efficacy data to identify and summarize findings and, as appropriate, may drive follow-up activities. (Co-)Author clinical study related documents including, but not limited to, protocols, charters, safety monitoring plans, IND reports, process documents, meeting presentations, publications, and clinical sections of regulatory documents such as INDs, briefing books, clinical study reports, investigator brochures, annual reports and updates, and clinical sections of regulatory submissions to support product approvals. Interface with discovery, safety sciences, statistics, PK/PD, regulatory, outcomes research, development operations, other members of the extended project team(s) Interact frequently with investigators, site staff, CROs, and site monitors to optimize study engagement, maintain enthusiasm, and support further enrollment for ongoing clinical studies. Maintain and analyze literature and competitive information for trial designs and results for assigned therapeutic area. Review and provide input on statistical analysis plan. Partner with Data Management for case report form (CRF) design, instructions for unique CRFs, and Data Quality Plan. Maintain current knowledge of the environment to ensure awareness of internal and external developments (scientific, clinical, competitive, and regulatory) that could impact the development plan by attending major scientific conferences, participating in competitive intelligence activities, and engaging in periodic literature review. RN, MS, PhD or PharmD, or equivalent. Advanced degree candidates preferred. 3+ years of industry clinical development experience, with experience in clinical trials. Extensive knowledge of clinical research, and experience across Phase I-III drug development projects. Familiarity with clinical trial design, and experience authoring clinical trial protocols (Phase I or II). Experience in analysis, interpretation, and presentation of clinical data in order to inform decision making and clinical strategy. Well-versed in medical aspects of GCP, ICH, FDA, EMEA and other relevant guidelines. Ability to work well independently and to organize priorities and deliverables. Experience working in a busy and highly collaborative biotech atmosphere as a part of a cross-functional team. Strong oral and written communication skills, including ability to present complex findings to senior management and external audiences and experts; prepare documents in support of regulatory submissions etc. Please complete the application below and include the following attachments: Cover Letter CV / Resume Research Summary (if applicable) Enanta Pharmaceuticals is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Enanta s research and development efforts are currently focused on the following disease targets: respiratory syncytial virus (RSV), non-alcoholic steatohepatitis (NASH)/ primary biliary cholangitis (PBC), and hepatitis B virus (HBV). Please visit www.enanta.com for more information.Enanta s research and development activities are currently funded by royalties from HCV products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is now sold by AbbVie in numerous countries as part of its newest treatment for chronic hepatitis C virus (HCV) infection. This leading HCV regimen is sold under the tradenames MAVYRET (U.S.) and MAVIRET (ex-U.S.) (glecaprevir/pibrentasvir). Enanta is located in Watertown, MA, just minutes from Harvard, MIT, and downtown Boston. We offer a competitive compensation program and a comprehensive employee benefits package. For more details, see our Careers page. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, religious creed, gender, gender identity, sexual orientation, physical or mental disability, protected veteran status, or any other class protected by law. Associated topics: doctoral, drug discovery, fellowship, lab, phd, postdoctoral, research, research fellow, scientist, toxicologist
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