Clinical Development Physician, Late Stage Oncology at Astellas Pharma in Markham, ON

Job description

About Astellas Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com. Are you driven to make a real difference in the lives of patients? We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact. Purpose and Scope: Due to the expanding portfolio, we are looking for Development Physicians/Medical Directors to join our clinical teams in late development Oncology at Astellas. Responsibilities and Accountabilities: Core member of the clinical team which is collectively responsible for the design and execution of one or more clinical trials. Serves as Medical Monitor with responsibility for safety monitoring on clinical studies. Generates safety related documents, such as medical monitoring reports . Collaborates closely with the safety officer in writing and/or reviewing safety narratives, investigator letters, and other safety documentation for site-reported safety events. With the Development Scientist, responsible for the medical aspects of all study-related documents, including for example the clinical study protocol, informed consent forms, clinical database, safety committee charters and clinical study reports. Works with Development Scientists and Clinical Operation Leads to ensure efficient and streamlined execution of clinical trials and acquisition and interpretation of high-quality clinical data to inform program-level decision making and overall development strategies. Supports functional level clinical development related initiatives as needed. Leads and/or participates in scientific and medical training to other team members and external clients, investigators, and other site staff as it pertains to assigned studies. Reports to the Global Medical Portfolio Lead for Late Oncology. Required Qualifications: MD or MD/PhD Must have 2+ years experience specifically in oncology clinical trial design and execution in a bio-pharmaceutical development organization or a balance of experience at an academic institution and a pharmaceutical company. Excellent verbal and written communication skills in English. Experience working in global teams and a global matrixed, remote working environment. Aware of cultural diversity and how to influence and manage in a multi-cultural organization. Highest level of scientific integrity and impeccable work ethics Preferred Qualifications: Board certified in Oncology or Oncology-related specialty Experience in solid tumors, preferably Gastro-Intestinal, Thoracic or Genito-Urinary Experience in late development oncology (Ph3) Direct experience leading global regulatory marketing authorization submissions and defense of those submissions Location and Working Environment This position is based in Ontario, Canada. Remote work from anywhere in Canada except Quebec is available. At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. This position is a global role with strong interaction with various disciplines and international stakeholders Highly matrixed environment requiring cross-regional coordination. Frequent interaction with senior leadership and governance bodies. Collaboration across EU, US, and Japan ti