Global Pharmaceutical Company
Project Physician is a medical expert who is accountable/responsible for the medical science expertise to generate clinical development strategy, design clinical development options, and deliver successful clinical development of responsible products in Japan.
PP is working closely with Medical Scientist.
His/her accountability/responsibility is mainly project-level, however, he/she is also involved in study-level activities as needed.
1. Project Level
・Lead D&I activities to generate Japan clinical development strategy with MS and ensure that Japan medical science views are appropriately incorporated in project development strategy
・Generate high-quality design options that characterize benefit, risk and value of medicinal products, focusing on reducing uncertainties and providing clear and transparent recommendations for decision and governance bodies.
・Ensure and champion consistent clinical science aspects and strategies across programs.
・Ensure optimal management of high impact project opportunities and risks.
・Review study design, regulatory documents consistent with the clinical strategy.
・Ensure delivering rationalized hypothesis, evidence based argument, and convincing interpretation in clinical science related documents.
・Input scientific information to internal documentation/slides such as IDP/CDP and governance document.
・Co-develop clinical science part of regulatory related documents with MS.
・Review CTD and ensure the consistency with agreed clinical strategy and medical science aspects are captured properly.
・Evaluate the safety data, describing industry's views for patient safety in CTD preparation, and point out information required for safety narrative and DSUR.
・Lead key contacts with external experts and help develop clinic-scientific alliance working with MS and global CPT.
・Act as a key point of contact for clinical science related relationship with external experts.
2. Study Level
・For Japanese standalone studies including regulatory required post marketing studies, lead development of clinical science part of clinical trial documents with MS.
・For global leading studies including Japan, review the document and ensure that medical scientific feasibility and ethical integrity in Japan is appropriately incorporated.
Act as a study physician of Japan standalone studies as well as support global study physicians of global leading studies to care for the following tasks:
・Provide clinical science support such as eligibility criteria, efficacy and safety data review to specific studies for risk mitigation. ・Ensure the medical/scientific accuracy in following documents:
・CSPs (incl. Master Informed Consent Form) and CSRs.
・IND and responses to Regulatory Authority.
・Approve following documents as a study physician:
・Study specification, Clinical Study Protocol and Clinical Study Report
・(if applicable) Japan specific part of Investigator Brochure
・Medical contents of Case Report Forms.
・Lead discussion at Investigators' meeting.
・Lead executing GPRMP for clinical studies.
・Provide clinic-scientific leadership to non-interventional study planning and reflect results on Japan D&I activities.
・Provide clinic-scientific leadership and support ESR in Japan.
・Input to publication strategy and contents/quality of publication
3. Collaboration with Marketing company
・Input scientific and medical perspectives into Japan commercial, pricing and medical strategy for product value maximization
・Compliance to company rules and external regulations
・Ensure that own work and all work within TA is performed in accordance with appropriate SHE and Compliance standards.
・Assumes other duties as assigned by the Medical Science Director2 Study Level
・The person who meets the requirements above Measures of Success:
・The context of clinical science input, including scientific risks, mitigations and setting right expectation of clinical development POS, is properly understood by the internal governance bodies for their quality decisions and by the internal stakeholders for the engagement.
・Optimum clinical science strategy is provided for optimum market access of the products within TA portfolio
・Medical Doctor degree
・Native level Japanese
・Fluent in spoken and written English for business
・Clinical practice as physician
・Planning of clinical development strategy and execution of clinical trials
・Negotiations with external experts and authorities
・Getting JNDA approval and supporting launch activities
・Communication ,Interview, Negotiation, Writing, Presentation and Facilitation skill
[Preferred Knowledge, Skills and Abilities]
・Doctor of Philosophy
※Experiences and skills will be considered
Osaka / Tokyo
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