Project Physician (PP) is a medical expert who is accountable/responsible for generating clinical development strategy, designing clinical development options, and delivering successful clinical development programs for its assets in Japan.
His/Her accountability/responsibility is mainly at project-level, such as generation of Japan clinical development strategy in collaboration with Clinical Scientist (CS) by providing expert knowledge as a physician-scientist. PP also shares the ownership with CS for any discussions of clinical part of JNDA strategy. PP is also involved in study-level activities as needed.
Other important responsibilities include: PMDA/MHLW interaction:
1) Co-development of documents for regulatory interactions such as BD for regulatory consultation, and
2) Query responses as a medical expert through collaboration with CS. KEE management: PP is responsible/accountable for KEE engagement from R&D perspectives including but not limited to group advisory board mtg and 1:1 consultation as local internal medical expert
The measure of success includes:
1) The quality and quantity of medical/clinical deliverables mentioned above for our ensures patients access to valuable medicines and
2) Leadership and appropriate behaviors.