【ジョンソン・エンド・ジョンソン株式会社】[Janssen] R&D, Japan Director, Oncology Clinical Development & Research – MD
仕事内容
ESSENTIAL FUNCTIONS:
Provide clinical leadership in JP project team to evaluate JP clinical inputs/recommendation to global clinical development strategy. Work closely with Regulatory, Project leader, and other functions.
Work closely with colleague clinical leaders/global medical head in TA ONC to ensure an integrated and strategic approach to flawless execution and systematic oversight of study protocol(s) in late development in close collaboration with key functional stakeholders.
Lead the clinical part of PMDA/MHLW interactions. Working closely with Medical Writing, responsible for the clinical related regulatory document development, ensure the strong evidence based clinical logic is in place to support company position. Responsible for the clinical strategy alignment within TA ONC and with other function stakeholders.
Lead the project scientists, ensuring appropriate training, mentoring, and supervision across the assigned study/studies within the clinical development program.
Represent the clinical program to interact with clinical investigators, key opinion leaders and business partners such as for CDx development.
Work with the compound Clinical Leader to support the development and compilation of JNDA and to support responses to PMDA questions and PMDA presentations post-filing.
May review/co-author medical publications emerging from clinical trial results.
May be asked to assess and plan for external clinical research opportunities in collaboration with compound Clinical Leader and BD.
May interact with medical consultants in concert with senior clinical staff, in conducting IDMC and Investigator meetings as well as Advisory Boards.
Provide support for clinical study/studies within a development program including:
Working closely and support the SRPs and clinical project scientists to ensure comprehensive medical monitoring, thorough and timely responses to address site issues and eligibility questions, and detailed, real time review of serious adverse events and deaths.
Collaborate with the compound Clinical Leader and Clinical Project Scientists on key study design elements.
Support SRPs to address protocol questions from Health Authorities and Ethics Committees in a consistent fashion.
Support SRPs to track study recruitment and implement action plans to address early impediments to study enrollment.
Support SRPs for medical review and data query resolution.
応募資格(必須経験など)
Qualifications:
An MD is required; Advanced degree (PhD) is a plus.
A minimum of 5 years of oncology clinical research experience in clinical development within pharmaceutical industry or equivalent experience in academic or large regional hospital is required. Clinical experiences in GI or hematology is a plus.
Knowledge of Good Clinical Practices and regulatory requirements for the plan the strategy and conduct of high quality oncology clinical trials is required. The experience of NDA submission and approval in GI or hematology is a plus.
Experience in protocol development, medical review, oversight of study conduct, running trials, data quality and safety are strongly preferred.
Working knowledge of the use of Microsoft suite of software products including Excel and Word is required.
Fluent in written and spoken English and Japanese with excellent communication skills is required.