Work on our Systemic Mastocytosis portfolio as well as BLU 808 trial.
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.
Attending 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
Education:
Masters, PhD, or PharmD in related field
Skills:
Allergy, Hematology, Oncology experience in a clinical setting
Languages:
English(Speak, Read, Write )
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Other
Industries
IT Services and IT Consulting
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