The Clinical Research Scientist, reports to the Director of Clinical Research and Development, and leads clinical activities for the development of nab-sirolimus in various solid tumor indications in accordance with budget and timelines in collaboration with clinical operations.PRIMARY JOB FUNCTIONSLead the development of clinical trial protocol (writing, reviewing, amending, and cross-functional facilitation as appropriate)Lead the development of key clinical documents such as Clinical Study Report, IND, NDA submission, etc., in coordination with concerned functions (e.G., Medical Writing, Regulatory, Biostatistics, etc.)Contributing clinical expertise and content to regulatory documentsConduct background research on new indications and studies to establish references and scientific baseAct as the primary interface between the Clinical Lead and Study Manager/Clinical OperationsProvide input & guidance to Study Managers on both scientific and operational issues related to the studyPartner with Study Managers to ensure consistency across individual studies and programs with respect to key execution processesReview draft CRFs and provide input into CRF design processReview data and analyses on an ongoing basis within the eCRF system, patient profiles, etc.
to issue queries and clean data from the clinical perspective, in conjunction with the Clinical Lead, including safety data, efficacy variables, and lab dataIdentify and resolve issues related to study design, execution, and safetyInterpreting study data and developing interim reports, as applicableParticipate and lead team meetings as requiredPresent or assist with the presentation of clinical data to data monitoring committees, investigators, etc.Facilitate Advisory Board and Investigator meetingsBachelor’s Degree required (life sciences preferred).
Ph.D., Pharm D., MPH, MS or equivalent degree in life sciences or medically related field preferredMinimum of 3 years of relevant clinical development experience (e.G., in clinical research, study management, or related) in the Biopharmaceutical industryExperience across all study phases, including design, execution, and analysisExperience in clinical project planning, including oversight of study deliverables, budgets, and timelinesExperience writing and presenting clearly on scientific and clinical issues, preferably clinical protocols and Clinical Study Reports and regulatory submissionsExperience collaborating and leading cross-functional teams (team/matrix environment)Knowledge of clinical trial design and able to use scientific and clinical knowledge to conceptualize study designsProficiency in data interpretationWorking knowledge of ICH GCP guidelinesAttention to detail with strong analytical and problem-solving skills and the ability to anticipate and resolve problemsHigh level of initiative and ability to work independentlyProficiency with MS Word, Excel, Outlook, Project, and PowerPointOTHER REQUIREMENTSThis role can be based in Los Angeles OR remotely in the U.S.
with travel to Los Angeles as needed