Job
Description
The Medical Expert in TCO (Translational Clinical Oncology) serves as the medical leader for assigned global, roll-over, and long-term follow-up studies, as well as studies in the close-out phase. Additionally, they may provide medical co-leadership for assigned aspects of global, active TCO studies under the guidance of a Clinical Program Leader (CPL). TCO, a department under the Biomedical Research division, is responsible for designing and conducting early-phase clinical studies in cancer patients, acting as a connection between drug discovery and late-phase clinical development to deliver innovative medicines for oncology conditions. Responsibilities include providing medical support to the CPL, contributing to clinical sections of protocols, Informed Consents, publications, regulatory documents, and reviewing clinical trial data. The Medical Expert may also oversee program safety reporting, represent the CPL at project team meetings and Investigator teleconferences, and lead the review of TCO submission documents. Furthermore, they are responsible for managing close-out, roll-over, and long-term follow-up studies, ensuring the quality of clinical study reports, and engaging with stakeholders internally and externally. The Medical Expert mentors junior team members, maintains expertise in regulations and procedures, and advocates for continuous improvement of quality. Key performance indicators include managing studies within timelines and regulatory standards, demonstrating strong scientific writing skills, providing quality medical review of trial data, contributing to department objectives, and receiving positive feedback from stakeholders. The role requires adherence to Novartis Values and Behaviors. Minimum Requirements: - MD or equivalent medical degree with clinical training and certification - At least 5 years of pharmaceutical industry experience - At least 2 years of clinical practice experience - Experience in hematology/oncology preferred - Knowledge of GCP and oncology clinical trials - Strong project management, communication, and interpersonal skills - Ability to work independently and in a team, adapt to changing environments, and network effectively Skills: - Clinical Monitoring - Clinical Research - Clinical Trial Protocol - Decision Making Skills - Drug Development - Health Sciences - Life sciences - Medical Strategy - Regulatory Compliance Language: - English Novartis offers a collaborative environment where passionate individuals can work together to achieve breakthroughs that positively impact patients" lives. For those interested in joining the Novartis Network, opportunities can be explored through the talent community to stay connected with suitable career options. Additionally, Novartis provides benefits and rewards to support personal and professional growth. Novartis is dedicated to fostering an inclusive work environment that represents the diversity of the patients and communities served. Accommodations for individuals with disabilities are available upon request to ensure equal opportunities during the recruitment process or job performance.,
