At Astellas, we strive to become a cutting-edge, value-driven life science innovator. This means working at the forefront of healthcare change to turn innovative science into VALUE for patients. **What sets us apart is our focus on patients, our pioneering innovation, our collaborative culture, and the passion of our talented people.** Making a positive impact on patients’ lives is the purpose behind everything we do. At Astellas, we are relentless in our pursuit of scientific progress and in tackling unmet medical needs, demonstrated by our legacy in oncology, overactive bladder and transplant and our impressive pipeline in women's health, blindness and regeneration, genetic regulation, immuno-oncology, mitochondria and targeted protein degradation. **About Us:** We are a global pharmaceutical company headquartered in Japan, with a team of more than 14,000 managing operations in approximately 70 countries around the world. We are in the Top 30 global biopharma company based on global revenues and are predicted to be one of the Top 10 Cancer Drug Makers of 2024 by Fierce Pharma. **In Canada, we are growing to meet the exciting opportunities realized by our legacy brands and rich pipeline of innovative treatments.** We are looking for candidates who will thrive in our entrepreneurial and empowering environment where talent and leadership flourish. Do your values align with our Astellas Way - patient focus, ownership, results, openness and integrity? Then we would love to hear from you. From the first day in role, everyone at Astellas has a responsibility for creating a brighter future for patients around the world. We nurture exceptional relationships with our employees to allow them to thrive, foster innovation, and deliver exceptional business results. We work to create a culture where our people feel empowered to pursue brave ideas and ambitious outcomes, to have the confidence to be accountable for a higher standard of performance and embody a competitive and solutions-oriented mindset. **Our expertise, science and technology make us a pharma company. Our open and diverse culture is what makes us uniquely Astellas.** **Description** Reporting to the Team Leader for Early Development Medical Safety, and as a member of the Asset Team, the Early Development Global Safety Officer (EDGSO) has primary accountability for providing clinical safety insight to support development and execution of clinical safety surveillance planning for compounds entering development, and for overseeing safety surveillance in the early development stage. The EDGSO joins the Asset Team just prior to Candidate Nomination (CN) and remains on this team until declaration of Proof on Concept, at which time safety oversight activities are fully transitioned to the Global Safety Officer for late-stage development and post-marketing safety oversight. Working in close collaboration with the Toxicology expert on the Asset Team, the EDGSO provides clinical expertise to help inform the development of Good Laboratory Practices (GLP) Toxicology study design as part of the Astellas Candidate Nomination Declaration Committee (CND-C) process, assessing data from non-GLP toxicology and pharmacology studies and considering projected product target and mechanism of action. During the Phase 0 period, the EDGSO will provide predictive clinical safety insights to inform the decision to move into clinical development, with focus on clinical interpretation of non-clinical risks, clinical risk assessment and potential mitigation strategies. Following entry into development, the EDGSO serves as the drug safety lead on the Asset Team, overseeing safety surveillance through the establishment of Proof of Concept. As the compound lead within Pharmacovigilance, the EDGSO serves as the primary liaison for other members of the Pharmacovigilance team, to ensure the communication of key compound safety messages and execution of safety strategies within PV. **Essential Job Duties** + Provides predictive clinical insights to support development of the GLP Toxicology studies at CN declaration. + Provides clinical perspectives on the developing preclinical GLP study package requirements to achieve the IND, by translating preclinical pharmacology and toxicology data into actionable safety strategies in early-stage/FIH studies. + Leads the development of the clinical safety strategy to be included in the Clinical Development Plan, integrated Safety Management Plan and early phase clinical study protocols + Co-chairs the Safety Management Team, in conjunction with the Development Medical Lead; drives the analysis and presentation of interim safety data from ongoing clinical studies at each SMT + Working with the Pharmacovigilance Scientist, PV Risk Management and Pharmaco-Epidemiology, the EDGSO oversees the creation of the initial Development Risk Management Plan. + Accountable for the overall safety surveillance of the compound in early development, including timely and thorough safety review as the lead for the Safety Management Team (SMT) meetings + Provides patient safety-related insights and assessments during the early development period to support periodic, stage-gate Asset assessments as part of the Quality Framework. + Provides effective communication and training to Regulatory Affairs and Pharmacovigilance teams (e.g., Safety Science, Epidemiology, Operations) to support robust execution of the safety strategy. + Accountable for providing rapid and effective communication of important safety issues to RAPV management, with thorough analysis of the issue and proposed mitigation/ management strategies + Represents the project team at the enterprise level and for external safety committees and/or Health Authority interactions for issues relating to clinical safety **Required Qualifications** + Advanced scientific degree (MD, PHD, PharmD) required, MD preferred + Minimum of 5 years’ experience in Clinical Drug Development as a development or drug safety physician, with at least 2 years’ experience in drug safety (e.g., safety signalling, risk management and mitigation) + Thorough understanding of and ability to interpret clinical, translational, and mechanistic data, with focus the clinical safety implications of preclinical data. + Excellent medical knowledge and safety surveillance expertise + Demonstrated ability to recognize, anticipate and communicate issues proactively + Understanding of drug safety regulatory requirements for investigational products, including ICH, 21 CFR, EU GVP and JP regulations + Track record in the strategic development and implementation of clinical safety assessment during the early drug development process. + Ability to drive decision-making and influence stakeholders in a matrix environment + Comfortable in a fast-paced, high pressure company environment and able to adapt to changing priorities. + Ability to deliver under pressure + Strong leadership, strategic thinking, interpersonal and communication skills + Demonstrated Enterprise mindset + Ability to interact with all audiences and clearly and concisely present data, strategy and risk assessment. **Preferred Qualifications** + 5 years’ experience in drug safety or pharmacovigilance is preferred + Early Development experience (i.e., supporting clinical trials up to Proof of Concept), with bridging of preclinical to clinical phases + Experience/ Medical knowledge in oncology, immunology, or cell and gene therapy development preferred + Work in a global or cross-cultural environment preferred \#LI-SS **Additional Information** Astellas Pharma Canada welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the hiring process. Astellas Pharma Canada requires full Vaccination against COVID-19 as a condition of employment. Reasonable accommodation to this policy may be granted for a valid accommodation request under human rights legislation. _No telephone inquiries, in-person applications, or agencies please. While we appreciate all applications, only candidates under consideration will be contacted._ Category Global Medical Safety Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans