(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.
Responsibilities Medical Expert for clinical study team
Protocol development from concept to final protocol
Protocol execution including interaction with investigators, and contributing to data review, data analysis and clinical study report authoring
Strategic 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 meetings
Development of medical content for regulatory document, and responses (including but not limited to NDAs/BLAs, sNDAs/SBLAs, briefing packages and common technical documents)
Data review
Requirements MD/MBBS/MBChB
Industry clinical or basic science research experience (5 years minimum)
Previous clinical trial experience as medical monitor in industry setting
Protocol development experience
Understanding of regulatory requirements related to clinical trials
Excellent written / oral communication skills in English
Interest in career progression and ability to take on a more senior roles in 1-3 years
Please click 'apply' or contact Mollie Laurens-Chalmers for any further information.
Job Types: Full-time, Permanent

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