An American company that helps patients at all stages of cancer
Create the Medical Affairs strategy to support current and planned diagnostics.
Put the needs of patients first and adhere to all relevant ethical, regulatory, and compliance standards in the execution of daily work.
Implement risk mitigation plans when needed. Ensure that clinical trials sponsored or supported by the company are conducted in accordance with applicable regulatory and compliance requirements.
Lead and participate in company supported scientific and educational events such as advisory boards, disease expert round tables, scientific presentations at leading medical institutions and within the company, and educational events at relevant scientific congresses.
Forecast and execute the Medical Affairs Department budget and financial reporting, including regular review to ensure that Department expenditures and deliverables are within plan.
Manage a team that will include Medical Director(s) and/or Medical Science Liaisons, including hiring, training, coaching, individual goal setting and performance feedback.
【REQUIREMENTS / DESIRABLE】
Medical Doctor or equivalent degree, board certified or board eligible in oncology or an oncology-related sub-specialty is highly preferred.
Knowledge of the treatment of cancer patients, including the incorporation of biomarkers and precision diagnostics in clinical decision making. Clinical experience is preferred but not necessary.
Minimum 7 years of oncology clinical trial experience in the context of drug or diagnostics development or commensurate academic experience.
Proven ability to run a team of medical professionals.
Demonstrated ability to understand and interpret the regulatory requirements under which medicines and/or medical devices are developed, reviewed, and supported in Japan.
Able to manage budgets, including long-term planning and actual performance within target.
Fluent in English