Oncology Clinical Scientist

Johnson & JohnsonChiyoda, Tokyo, JapanonsiteSalary not postedView the original posting at 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 jnj.com . 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. 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 Job Description: ABOUT INNOVATIVE MEDICINE 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. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for an Oncology Clinical Scientist (Manager) to join our Clinical Development team in Japan. Purpose: Help bring innovative oncology medicines to patients in Japan. In this role, you will drive the development and execution of the Japan Clinical Development Plan, working closely with the Global Clinical Development Team to align it with global asset and program strategies. Through clinical science support for studies conducted in Japan, from protocol development through to PMDA interactions, you will help deliver high-quality, compliant and timely clinical development outcomes, with the opportunity to contribute to global studies as a Study Responsible Scientist. Based on the clinical trial results obtained, you will also lead the regulatory submission for approval in Japan. You will be responsible for: Contributing to Japan clinical development strategies aligned to global asset and program plans, and drafting Japan local protocols, amendments and planning documents Leading local companion diagnostic (CDx) development with support from the global CDx team Providing clinical oversight of trials in Japan, partnering with Clinical Operations on feasibility, investigator interactions, site training, enrolment and protocol interpretation Supporting and performing eligibility and medical review, and interpreting study results with the broader study team to inform trial conduct, development strategy and regulatory decisions Contributing to key clinical documents, including clinical study reports, protocols, informed consent documents and CRFs, through section authorship and quality control Preparing clinical sections of Japan regulatory submissions and responses to PMDA inquiries, and participating in PMDA consultation meetings Contributing to global study activities when assigned as a Global Study Responsible Scientist (SRS) Key interfaces Global Clinical Development Team (CDT) and Clinical Operations (GCO) Biostatistics, data management, safety/pharmacovigilance, regulatory affairs, medical writing, quality, translational sciences and medical affairs PMDA Investigators, key opinion leaders, external advisors and vendors Measures of success High-quality, compliant and timely delivery of Japan clinical studies and Japan components of global trials Scientifically accurate, consistent and compliant clinical documents and regulatory submissions Timely identification and escalation of clinical issues Strong cross-functional alignment across the

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