- ”Associate Principal Scientist Clinical Research, Oncology Scientific Affairs (OSA), Oncology Science Unit (OSU), Japan Development (JD)”
OSA Strategy and Roles/Responsibilities
1.Scientific Leader (SL) Engagement:
A)Proactively deliver non-promotional and unbiased scientific information to SLs by leveraging corporate R&D and company resources.
B)Conduct competitive scientific/medical and industry competitive intelligence (CI) and provide insights to the corporate R&D and the company.
C)Develop, update and implement strategically oriented site/SL engagement plan in collaboration with global and local R&D functions.
D)Develop, update and maintain SL list by utilizing a relevant system.
E)Proactively engage internal stakeholders to enable SLE in productive manners.
F)Explore scientific collaboration opportunities with academia in collaboration with corporate R&D functions.
A)Identify investigator initiated study (IIS) opportunities in oncology pre-clinical, clinical and translation areas, and lead/facilitate required processes including but not limited to pre-review, review, communication of corporate R&D and company decisions, contracting with investigators and follow up in collaboration with corporate R&D and company functions.
B)Lead, facilitate and support LDG by collaborating with corporate R&D and company functions.
3.Publication Support and Management:
A)Manage the development, tracking and update of Publication Plan
B)Support/Coordinate globally lead congress presentation and publication according to the Publication Plan in collaboration with corporate R&D and company functions.
C)Manage locally lead congress presentation and publication according to the Publication Plan in collaboration with corporate R&D and company functions.
A)Plan and organize on-site scientific/medical CI.
B)Manage OSU post-congress reporting process in OSU.
C)Manage and coordinate on-site SL engagement in accordance with the OSA SL engagement strategy and plan by collaborating with corporate R&D and company functions.
5.Medical Event and Advisory Meeting:
A)Plan and implement Japan local scientific advisory meeting named Japan Scientific Advisory Meeting (J-SAM) in collaboration with corporate R&D and company functions.
B)For matters relevant to Japan local (and Asia) clinical development and New Drug Application (JNDA), plan and implement locally organized advisory meeting in collaboration with corporate R&D and company functions.
C)In alignment with the corporate and local R&D strategies and objectives, plan and implement medical event by collaborating with internal and external stakeholder.
6.Medical Expertise (apply only to a licensed physician in Japan):
A)Medical Consultation and Assessment:
①Assess borderline cases to determine incorporation or deviation.
②Determine relationship between the investigational therapy and reported events.
③In case of observed dose limiting toxicity (DLT)and/or serious adverse event (SAE), lead and manage site visit for medical engagement and education/consultation, and review/submit report to the responsible internal committee.
B)Medical Review: Conduct a review of protocol, informed consent form (ICF), Investigator’s Brochure, press release and/or a report of SAE.
C)Medical Monitoring: Conduct adverse event (AE) check, baseline chest CT in lung trials.
D)Medical Education: Conduct medical, including but not limited to immune-related adverse event (irAE), education for health care providers in relation to oncology clinical development and other global and local R&D initiatives.
E)irAE Management: As a member of OSU MD Group, collaborate with all necessary functions to lead and manage external medical interactions with health care providers.
A)Develop, update and maintain an internal control framework relevant to OSA responsibilities.
B)Develop, update and maintain business standards, including but not limited to written procedure, guidance, other supportive documents and tools relevant to OSA responsibilities in collaboration with corporate R&D and company functions.
C)Monitor and track progress against plan and analyze (e.g., through feedback, After Action Review) to adjust for re-planning as necessary.
D)In addition to individual contribution, embed team-based work environment to enhance organizational capability and capacity through demonstrating our company’s Leadership Behaviors.