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About the Role

As the Japan Clinical Lead for Oncology, you will provide Japanese insights and clinical expertise to shape global clinical development strategies. You will act as a Study Responsible Physician or Scientist, overseeing the execution of clinical studies in Japan and contributing to a global, matrixed team.

Responsibilities

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).
Lead the clinical part of PMDA/MHLW interactions.
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.
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 medical monitoring, review of eligibility, efficacy, safety, coding, protocol deviation, etc.
Manage 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.
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.

Requirements

A minimum of 5 years of clinical research experience in clinical development within the pharmaceutical industry, or equivalent experience in academia, is required.
Knowledge of Good Clinical Practices and regulatory requirements for the plan the strategy and conduct of high quality oncology clinical trials is required.
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.

Skills

Clinical Research and Regulations
Clinical Trials
Clinical Trials Operations
Collaboration
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

Location

Chiyoda, Tokyo, Japan

Work Type

Hybrid

Experience Level

5+ years

Education Level

BS or above in biology, pharmacology or related scientific specialties required. PhD preferred. MD holders may also apply.

About the Company

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.
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
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.

Equal Opportunity

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.