Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.
This position is based in Ontario, Canada. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
Purpose and Scope:
Reporting to the Team Leader for Early Development Medical Safety, and as a member of the Asset Team, the Early Development Safety Physician (EDSP) 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 EDSP 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 EDSP 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 EDSP 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 EDSP 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 EDSP 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 Responsibilities:
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 EDSP 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 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 PV 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.