(Mh177) Clinical Development Director

You will serve as a medical expert for the study team and medical monitor for Phase 2-4 clinical trials. This position additionally offers substantial opportunities for regulatory and commercial interactions and career advancement in the fast-moving area of rare disease.ResponsibilitiesMedical Expert for clinical study teamProtocol development from concept to final protocolProtocol execution including interaction with investigators, and contributing to data review, data analysis and clinical study report authoringStrategic guidance to phase II/III development programs and oversight of global clinical trials/trial team(s) on assigned program(s)Presentation at academic congresses, investigator meetings and advisory meetingsDevelopment of medical content for regulatory document, and responses (including but not limited to NDAs/BLAs, sNDAs/SBLAs, briefing packages and common technical documents)Data reviewRequirementsMD/MBBS/MBChBIndustry clinical or basic science research experience (5 years minimum)Previous clinical trial experience as medical monitor in industry settingProtocol development experienceUnderstanding of regulatory requirements related to clinical trialsExcellent written / oral communication skills in EnglishInterest in career progression and ability to take on a more senior roles in 1-3 yearsPlease click 'apply' or contact Mollie Laurens-Chalmers for any further information.Job Types: Full-time, Permanent
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