(Janssen) R&D, Japan Sr/Clinical Lead, Clinical Development TA Oncology

About Johnson & Johnson
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 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:
1. 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.
2. 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.
3. 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 develop m ent 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/ scientist s 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 S tudy Responsible Scientist, i n collaboration with other functional disciplines, including G lobal Clinical O peration , 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. W ork ing 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 c linical l ead 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 c linical 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.
•S upport 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 c linical l ead and B usiness D evelopment .
• 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
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.