Program/Project Responsibility

•Actively contribute to building the TCO Japan organization in line with the strategic vision of TCO in Japan.
•Provide medical input during regular reviews of TCO portfolio to identify and recommend programs appropriate for development in Japan, as aligned with the country’s development & portfolio strategy.
•Collaborate closely with TCO Japan Program Management and TCO Japan Clinical Sciences Trial Leadership teams, provide medical guidance and support for TCO projects.
•Work closely with the BR Early Strategic Partnership (BR-ESP) function to support medical and scientific discussions with academic partners/research institutions.
•Partner with key functions (such as but not limited to Regulatory Affairs, SSO, Development, International) to accelerate TCO deliverables, to enable Japan to participate in pivotal enabling studies in real-time, and to strengthen TCO’s position within Novartis Japan organization.
•Act as an interface between global TCO CPL and the TCO Japan team. Serve as the medical lead for Japan within the global BR Project Team (BPT) as needed.
•Provide Japan-focused medical input to global TCO CPL, TCO BPT, and TCO DAL as required (e.g., up-to-date therapeutic landscape of key disease area in Japan, epidemiology data, local clinical guidelines, local competition landscape, etc.).
•Engagement with investigators and key medical experts in Japan. Gather local clinical insights (patient population, indications of interest, local treatment paradigm, etc.) and collaborate with the local medical community to establish a qualified network of TCO sites in Japan.
•May represent TCO Japan during interactions with regulatory agencies or other local authorities as appropriate.
•Strive to always ensure compliance with Japan’s regulatory requirements.
•Advocate for continuous improvement of quality. Maintain or exceed compliance obligations for Good Clinical Practice, Novartis standards operating procedures, and country regulations.

Minimum Requirements/Skills

•MD degree with experience in Oncology.
•Clinical experience in Radiation Oncology / Radiology / Nuclear Medicine either in academic institutions or industry would be an advantage.

•Board certification (or equivalent) in Oncology / Radiation Oncology / Radiology / Nuclear Medicine would be an advantage.
•Pharmaceutical/biotechnology industry experience is preferred.
•Prior experience in clinical trials (leading, managing or participating), preferably in early development.
•Prior exposure to fundamental, preclinical research would be an advantage.
•Basic knowledge of statistics and pharmacokinetics required.
•Familiarity with all aspects of drug development and Good Clinical Practice.
•Knowledge of regulatory requirements for clinical trials in Japan would be an advantage.
•Good presentations skill, effective communication and time management, problem-solving abilities. Able to work in a multi-cultural environment and in a matrixed global organization.
•Flexibility for domestic travel.

Language

•Fluency in Japanese and English (oral and written)