Clinical Scientist
45 Sidney Street Cambridge, MA 02139 US
Job Description
- Work closely with Medical Directors, Pharmacology, Discovery, external experts, and investigators to accumulate scientific and medical knowledge necessary to support clinical development plans and study designs and protocols
- Assist Medical Directors in creation of proposed concept sheets for clinical studies and may write protocols and informed consent documents through incorporation of input from both internal and external experts
- Assist with the annual update of IB with input from Toxicology, Pharmacology, Safety, Regulatory
- Drive and integrates clinical contribution to answering regulatory queries and other submissions related to studies
- Monitor and review along with the medical monitor safety and efficacy data in ongoing studies? monitors GCP compliance with help of clinical operations and CRO
- Involved in high level data cleaning activities requiring clinical judgment Involved in analysis of complex data for regulatory submissions, publications and design of studies and programs
- Attend scientific meetings to remain abreast of new developments within relevant areas and to interact with investigators, and advisors
- Work with investigative sites to answer protocol related questions, resolve study conduct and design issues
- May present data, protocol designs and other information at advisory boards, investigator meetings, site initiations and other internal and external settings
- Masters, PhD, or PharmD in related field
- Allergy, Hematology, Oncology experience in a clinical setting
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