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*Job Function:*
Discovery & Pre-Clinical/Clinical Development

*Job Sub Function:*
Clinical Development & Research – MD

*Job Category:*
Scientific/Technology

All Job Posting Locations:
Chiyoda, Tokyo, Japan

*Job Description:
This position is open to candidates with either an MD or non-MD background. Please refer to the detailed job description below for specific requirements.
MD JD:*
Johnson & Johnson Innovative Medicine R&D is recruiting for (Associate) Medical Director/ Clinical development – TA Oncology. This position is located in Tokyo office. In general, we come to office 3 days/wk.

At the Johnson & Johnson Innovative Medicine, 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: (Associate) Medical Director, Clinical development-TA Oncology.

Act as Study Responsible Physician (SRP) to oversee and ensure the flawless execution of assigned clinical studies in Japan. A member of global clinical team. Counter part of colleague study responsible physician. Act as JP clinical leader 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 leader. If successful to provide mentorship and support to clinical project 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, Associate Medical Director, 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 SRP and/or the clinical leader, closely with the clinical project scientists/senior clinical leader/medical director in early and/or Late Development programs.

As a SRP, You will collaborate with other functional disciplines, including GCO (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. For the global trials, you will work with the lead SRP and other SRPs as a team, who may locate in different countries or regions.

If you are assigned as a clinical leader, you will 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.

Essential Functions:

• Lead the clinical scientists, ensuring appropriate training, mentoring, and supervision across the assigned study/studies within the clinical development program.
• Work closely with functional partners in Data Management, Biostatistics, Regulatory, GCO, 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.
• Provide support for clinical study/studies within a development program including:

Working closely with the colleague study responsible physicians and clinical project scientists in collaboration with GCO and GMS 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. Work closely with clinical scientists and data management to support medical review and data query resolution. Working in partnership with colleague SRPs and clinical project scientists to ensure high quality Japan inputs to study protocols including use of consistent processes/standards across studies. Advise in strategic study start-up planning in collaboration with GCO including early site assessment, feasibility, and use of simplified contract to accelerate site activations. Co-lead and oversee clinical part of informed consent forms, eCRFs, study manuals, clinical study reports, and regulatory submission documents. Work closely with Medical Writing to support protocol or protocol amendment completion. Work closely with compound Clinical Leader, medical directors, Regulatory and GCO to address protocol questions from Health Authorities and Ethics Committees in a consistent fashion. Work closely with GCO to track study recruitment and implement action plans to address early impediments to study enrollment. Interact with clinical investigators, steering committee members and Key Opinion Leaders as appropriate. Work with the compound Clinical Leader, Data Management and with Statistics on analysis of study results and completion of study reports.

• 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.

*Qualifications - External*
An MD is required; Advanced degree (PhD) is a plus.

• A minimum of 2 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 CRC/GI or hematology is a plus.
• Knowledge of Good Clinical Practices and regulatory requirements for the conduct of high quality oncology clinical trials is required.
• 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.

This role will report to TA ONC JP Hematology/solid tumor leader. In Johnson & Johnson Innovative Medicine R&D, a global MD dedicated career path is in place to provide multiple opportunities for different personal career aspirations. Based on personal aspiration and business needs, there are multiple future development opportunities as both senior matrix team clinical leader/medical director roles and people leader roles locate in or outside of JP.

Non-MD JD:
Johnson & Johnson Innovative Medicine R&D is recruiting for Japan Clinical Lead/Clinical Development – TA Oncology. This position is located in Tokyo 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, you will 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.
• 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 ONC 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 clinical project scientists/physicians 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 lead on key study design elements.
• Support clinical project scientists/physicians to address protocol questions from Health Authorities and Ethics Committees in a consistent fashion.
• Support clinical project scientists/physicians to track study recruitment and implement action plans to address early impediments to study enrollment.
• Support clinical project scientists/physicians 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 IDMC 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.

• A minimum of 5 years of oncology clinical research experience in clinical development within pharmaceutical industry or equivalent experience in academic institutions is required. Clinical experiences in Gastrointestinal (GI) and Genitourinary (GU) 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 GU 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.

This role will report to TA ONC JP solid tumor leader. 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:*
Clinical Development

*Preferred Skills:*
Clinical Research and Regulations, Clinical Trials, Clinical Trials Operations, Collaborating, Consulting, Data Management and Informatics, Drug Discovery Development, Industry Analysis, Innovation, Leadership, Market Research, Regulatory Affairs Management, Research Ethics, Scientific Evaluation, Scientific Research, Stakeholder Management, Tactical Planning, Technical Credibility