Assoc Dir Clinical Scientist Oncology

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: Raritan, New Jersey, United States of America Job Description: The Clinical Project Scientist is responsible for the design, planning, implementation, monitoring, and reporting of clinical research trials. The following responsibilities will be demonstrated in varying degrees of participation and leadership: Partners with Study Responsible Physician (SRP) to provide clinical oversight to the study; Develops clinical research protocols, study case report forms, informed consent; Develops the medical review plan to support the statistical analysis plan; Plays a key role in the medical review of the study data and assists in coding, analysis and documentation Validates and interprets results of phase II- IV investigations in preparing new drug applications to the appropriate health authorities, scientific congresses, and peer-reviewed journals Ensures team member adherence to clinical research guidelines and safety procedures; Communicates detailed outcomes and results of research findings to relevant partners; Provides input in managing project budgets and projections; Serves as liaison to global clinical sites for medical questions related to the clinical research trial ; Presents study status at internal/external meetings, including investigator meetings and governance committees Trains and mentors local/central study teams and investigative sites on the study protocol, ensuring they have the necessary guidance and tools for performance of various project activities Participates in/leads interactions with health authorities; Maintains expertise on clinical trial documentation, requirements, regulations, operational procedures, study file requirements, regulatory requirements, policies; Reviews and maintains correct standard operations, procedures and protocol Required Skills: Preferred Skills: Clinical Evaluations, Corrective and Preventive Action (CAPA), Drug Discovery Development, Entrepreneurship, Good Clinical Practice (GCP), Leadership, Medicines and Device Development and Regulation, Presentation Design, Regulatory Affairs Management, Relationship Building, Research Documents, Safety-Oriented, Scientific Research, Strategic Change, Study Management, Tactical Planning, Technical Credibility Apply To This Job