• 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
Requirements:
• Masters, PhD, or PharmD in related field
• Allergy, Hematology, Oncology experience in a clinical setting
Location: Cambridge, MA
Posted: Oct. 27, 2024, 9:35 p.m.
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