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Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Clinical Development & Research – Non-MD

Job Category:

Scientific/Technology

All Job Posting Locations:

Chiyoda, Tokyo, Japan, Osaka, Japan

Job Description:

ジョブの説明：

Johnson & Johnson Innovative Medicine R&D is recruiting for Japan Clinical Lead/Clinical development – TA Oncology. This position is located in Tokyo or Osaka office. In general, we come to office 3 days/wk.At the Johnson & Johnson Innovative Medicine, guided by "Our Credo", what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Johnson & Johnson Innovative Medicine discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience and cardiovascular and metabolic diseases.

Summary of the Role: Japan Clinical Lead, Clinical development-TA Oncology.

Act as JP clinical lead of a matrix team to provide JP insights and clinical expertise to develop a global clinical development strategy. A member of global clinical team. Counter part of compound clinical lead and/or global medical head.

Act as Study Responsible Scientist (SRS) if assigned to oversee and ensure the flawless execution of assigned clinical studies in Japan. A member of global clinical team. Counter part of compound study responsible physician (SRP) and SRS. If successful to provide mentorship and support to junior clinical project physicians and/or scientists.

J&J IM R&D is a global organization and our JP team is part of the global TA ONC. As one international team, we work closely with colleagues locate around the globe. This role, Japan Clinical Lead, will contribute to the global clinical development strategy via providing deep JP knowledge and clinical expertise of the tumor types.

You will work in a matrix team as a JP clinical lead, closely with the clinical project physicians/scientists in early and/or Late Development programs. You represent the JP clinical matrix team in relevant global clinical meetings relating to the overall strategy and operational implementation of the clinical studies in the development plan. You also oversee the execution of oncology clinical studies, ensuring consistency and quality, across the assigned development program.

If assigned, you will also work as the Study Responsible Scientist, in collaboration with other functional disciplines, including Global Clinical Operation, Data Management, Statistics, Regulatory, etc to ensure flawless and integrated execution of start-up planning, oversight, and reporting of clinical studies in Oncology.

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. High level of autonomy for local matters and decision accountability for a project are required.

• Work closely with compound clinical leads/global medical head in TA ONC to ensure an integrated and strategic approach to flawless execution and systematic oversight of study protocol(s) in early and/or 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 Oncology and with other function stakeholders.

• Lead the clinical project scientists/physicians, 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 lead to support the development and compilation of JNDA and to support responses to PMDA questions and PMDA presentations post-filing.

• Provide support for clinical study/studies within a development program including:

• Working closely and support SRS/SRP 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.

• Reviews data for assigned studies, including conducting reviews on eligibility, efficacy, safety, coding, protocol deviation, etc.

• Manages inquiries from/to data management, study operation team or investigators.

• Collaborate with the compound clinical lead on key study design elements.

• Support SRS/SRP to address protocol questions from Health Authorities and Ethics Committees in a consistent fashion.

• Support SRS/SRP to track study recruitment and implement action plans to address early impediments to study enrollment.

• Support SRS/SRP for medical review and data query resolution.

• 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 lead and Business Development.

• May interact with medical consultants in concert with senior clinical staff, in conducting Independent Data Monitoring Committee and Investigator meetings as well as Advisory Boards.

• As an advisor, may support MAF (medical affairs) with developing an evidence generation plan for value maximization in Japan

Qualifications

• External

B.S. or above in biology, pharmacology or related scientific specialties are required. PhD is preferred. M.D holders may also apply.

• A minimum of 10 years of clinical research experience in clinical development within the pharmaceutical industry, or equivalent experience in academia, is required. Experience in lung, gastrointestinal (GI), and/or head and neck (H&N) oncology 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 New Drug Application (NDA) submission and approval in Lung, GI and/or H&N 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.

• Fluency in written and spoken English and native‑level proficiency in Japanese, with excellent communication skills, is required.

This role will report to TA Oncology JP director. Based on personal career aspiration and business needs, there are multiple future development opportunities such as senior matrix clinical team lead role and people leader role located in or outside of JP.

Required Skills:

Preferred Skills: