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[Janssen] R&D, Japan Associate Director, Oncology Clinical development & Research MD - 2406203964W

Description

About Johnson & Johnson

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

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.

1. 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.

2. 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.

3.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:

1) 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.

2) Work closely with clinical scientists and data management to support medical review and data query resolution.

3) 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.

4) 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.

5) Co-lead and oversee clinical part of informed consent forms, eCRFs, study manuals, clinical study reports, and regulatory submission documents.

6) Work closely with Medical Writing to support protocol or protocol amendment completion.

7) 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.

8) Work closely with GCO to track study recruitment and implement action plans to address early impediments to study enrollment.

9) Interact with clinical investigators, steering committee members and Key Opinion Leaders as appropriate.

10) 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

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.

Primary Location Asia Pacific-Japan-Tokyo-To-Chiyoda

Organization Janssen Pharmaceutical K.K. (7195)

Job Function Clinical Development & Research & MD

Req ID: 2406203964W