ProClinical, in support of our client, are seeking a talented and experienced individual to fill the role of Clinical Scientist, based in Cambridge, MA.
- Lead the clinical study protocol development process by translating the strategy and approved concept.
- Contribute to the development of the plan to execute on trial design including CRF design, data review plan, statistical analysis plan review and finalization.
- Collaborate within development on the review, analysis, and interpretation of study results. Assure appropriate data review and accurate data reporting.
- Identify study issues and program issues by reviewing and monitoring of emerging clinical data related to safety, efficacy and PK/PD.
- Develop solutions to issues and collaborates with the clinical study team to ensure issue resolution.
- Conduct literature reviews for the interpretation of study data and development of next steps.
- Work with the medical monitor to assure they are informed of pertinent study information.
- Support the development of program documents.
- Support the implementation of target/pathway engagement assays for selecting therapeutically relevant doses and schedules; support stratification biomarkers.
- Develop presentations and communicate study data results to internal and external audiences.
- Review and summarize study data, including experience in preparing and presenting data.
- Understand, interpret and communicate clinical information.
- Maintain current knowledge of the external environment to ensure scientific innovations are considered and/or incorporated into clinical trial development strategy.
Skills And Qualifications
- Advanced clinical or science degree (additional board certification preferred) required and 10+ years of clinical, technical/operational experience in clinical studies within the pharmaceutical industry.
- Experience performing systematic literature search, summarizing the search results and presenting the conclusions to wide spectrum of audience.
- Detailed knowledge of GCP, ICH Guidelines and current US FDA regulations.
- Understanding of the drug development process from pre-IND through registration and post-registration required.
- Broad understanding of functional areas of drug development.
- Understand trial design and statistics in order to apply knowledge to the design of clinical protocols.
- Good track record in the interpretation, analysis and presentation of clinical data.
- Strong written, verbal, and interpersonal communication skills, as well as English fluency.
- Ability to travel up to approximately 30% of time.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Jason Thiagaram at (+1) 646-367-2910 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
£0.00 - £60000.00 per annum
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