Provide medical expertise in the Study team to conduct the clinical studies from early phases to LCM programs
Collaborate with other medical and clinical scientific experts DMDs or DSDs in the project under the leadership of the Global Project Head, with the Global safety Officer, Regulatory Strategist and other key functional representatives to deliver development strategy and prepare/assist with regulatory bodies interaction
Develop the study level regulatory documentation (Abbreviated Protocol, Protocol, Amended protocol) for their project, lead other development activities pertaining to study start-up (e.g. pressure test, competitive intelligence, patient engagement, cluster feasibility, study risk assessment etc…)
Provide appropriate medical input & support for all activities related to clinical studies conduct such as answers to IRBs and HA questions, protocol scientific and medical training, medical review of data within the scope of the Centralized monitoring, clinical and medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators
Contribute to the clinical part of Common Technical Document for submission to regulatory bodies (FDA, EMA, PMDA etc…) and answer to questions from health authorities.

At least 3 years previous experience in clinical development in pharmaceutical industry or a CRO or medical experience in clinical development in an Healthcare institution
Background in respiratory, allergy, or immunology preferred.
Understanding of pharmaceutical product development and life cycle management
Very good Scientific and medical/clinical expertise
Very good expertise in clinical development and methodology of clinical studies
MD (Doctor of Medicine) or equivalent patient care-related medical degree (DO, international equivalents, etc.) required
English fluent (spoken and written)

Development Medical Director

Key skills