Clinical Scientist (13-127) FibroGen
Job Location: Project Management
The Clinical Scientist, FG-3019 Clinical Development for Idiopathic Pulmonary Fibrosis (IPF), is capable of providing assistance in the medical monitoring of clinical trials in IPF, assisting Medical Monitor in management of subjects in the trials, communicating with site study coordinators and investigators, writing sections of clinical study protocols and amendments, study reports, and narratives, preparing clinical updates and summaries of study data, and independent data reconciliation, review, trending, analysis and interpretation.
This position will report to the Sr. Director, FG-3019 Clinical Development for IPF, and will work closely with the IPF clinical operations team members, as well as other Sr. Directors in FG-3019 Clinical Development, the FG-3019 Project Leader, members of the IPF Study Operations Team (SOT), and the CMO.
Assist the Sr. Director, FG-3019 Clinical Development for IPF, in medical monitoring duties, communications with sites, IPF clinical operations team members, SOT members, and contractors, and clinical trial data filing and medical management of trials.
With Sr. Director, provide medical decision-making for management of subjects in IPF clinical trials, including decision-making regarding subject safety
Writing of protocol sections, amendments, clinical study reports and narratives, and other communications including the Annual Report and the Investigator?s Brochure
Prepare presentations of clinical study updates to internal staff and scientific communications to external groups, including professional societies and patient advocacy groups
Working under the Sr. Director?s direction, conduct literature searches, safety and efficacy data reconciliation, checking, analysis, interpretation, and reporting
Provide medical direction and strategic clinical trial input to the IPF clinical operations team
Support the Sr. Director(s) in other FG-3019 therapeutic areas in similar duties in Liver Fibrosis area.
Medical Doctor Degree, or equivalent, with at least two years? industry experience performing Clinical Scientist type activities described above
A PhD or RN with at least 8 years? equivalent experience may also be considered
Thorough knowledge and understanding of the pulmonary medicine therapeutic area
Knowledge of clinical trial design, data interpretation and analysis
Ability to analyze, interpret, and report clinical trial findings
Effective oral and written communication skills
Advanced skills in Word, Excel, and PowerPoint
Strong statistical analysis background is desirable
Strong interpersonal skills and ability to work effectively with Sr. level as well as MDS, project teams, Quality Control, Data Management, Safety, Biometrics, and Clinical Operations staff
||San Francisco, CA |