Position Title: Scientific director.Length of Contract: 6 months, possibility to extendLocation/Site: RemoteInterviews – 2 virtual interviews JOB Summary The Scientific Director (SD) will provide scientific and clinical input to early and late-stage oncology clinical development programs with an emphasis on protocol-specific and medical data review activities. This includes collaborating on the design, implementation and execution of study protocols. They will be responsible for the review of data from assigned clinical trials, as well as assist with data interpretation and communication to both internal and external stakeholders. The SD may also assist in health authority and ethics committee communications, as appropriate.primary responsibilitiesPartner on study teams of internal experts (e.g. medical, safety, clinical operations, statistics, precision medicine, clinical pharmacology, regulatory) to execute clinical studiesCollaborate with the Medical Director to strategize and build innovative, robust clinical development plans and trial designsDevelop and maintain clinical trial protocols, related manuals/documents, and study reportsReview informed consent, lab manuals, CRF designs, clinical query design, deviations, etc.Review materials to support SIVs, Investigator Meetings, and Safety Review CommitteesReview clinical database on a routine basisIdentify clinical trends in datasets and escalate as appropriateReview and validate clinical study reports and clinical portions of other regulatory documents (e.g. IB, DSUR, responses to health authorities)Provide scientific expertise and support for regulatory filings and interactions, including responses to health authoritiesAuthor internal clinical documents, abstracts, posters, and presentations for scientific and clinical conferencesProvide asset development updates to management as appropriateQUALIFICATIONSAdvanced Clinical/Science Degree is required (e.g. MD, Pharm.D., Ph.D., MSN) A Master’s degree may be considered with supporting industry experience.A minimum of 5 years experience in clinical science, clinical research, clinical development or equivalent in oncologyProficient knowledge of oncology, analysis and interpretation of clinical data (safety and efficacy), GCP/ICH, study design, statistics, biomarkers, pharmacokinetics, clinical operations, and regulatory requirement for clinical studiesAble to communicate (written and oral) clinical and scientific data to a broad range of audiencesHigh level of organizational and project management skillsOperate with a high degree of autonomy and professionalism Enable Skills-Based Hiring No Provide the days of the week and the hours that this position will require: (No Value)
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.This position's pay range is $7.25/hr - $80.00/hr.