Overview
Early Development Global Safety Officer at Astellas Pharma. This role reports to the Team Leader for Early Development Medical Safety and serves on the Asset Team, accountable for providing clinical safety insight, developing and executing safety surveillance plans for compounds entering development, and overseeing safety in early-stage development.
The EDGSO joins the Asset Team prior to Candidate Nomination (CN) and remains until Proof of Concept (PoC), at which point oversight transitions to the Global Safety Officer for late-stage and postmarketing safety.
Hybrid Working: Astellas offers a hybrid work model with a blend of office and home-based work. Location-based eligibility may apply per company guidelines.
Responsibilities And Accountabilities
* Providing predictive clinical insights to support development of GLP Toxicology studies at CN declaration.
* Offering clinical perspectives on preclinical GLP study package requirements to achieve the IND, translating preclinical pharmacology and toxicology data into actionable safety strategies in early-stage/FIH studies.
* Leading development of the clinical safety strategy for inclusion in the Clinical Development Plan, integrated Safety Management Plan, and early phase clinical study protocols.
* Co-chairing the Safety Management Team with the Development Medical Lead, driving analysis and presentation of interim safety data from ongoing clinical studies at each SMT.
* Collaborating with the Pharmacovigilance Scientist, PV Risk Management, and Pharmaco-Epidemiology, overseeing creation of the initial Development Risk Management Plan.
* Being accountable for overall safety surveillance of the compound in early development, including timely and thorough safety review as lead of the Safety Management Team (SMT) meetings.
* Providing patient safety insights and assessments during early development to support periodic, stage-gate Asset assessments as part of the Quality Framework.
* Delivering effective communication and training to Regulatory Affairs and Pharmacovigilance teams (e.g., Safety Science, Epidemiology, Operations) to ensure robust execution of the safety strategy.
* Ensuring rapid and effective communication of important safety issues to RAPV management, including thorough analysis of issues and proposed mitigation/management strategies.
* Representing the project team at the enterprise level and in external safety committees and/or Health Authority interactions on clinical safety matters.
Required Experience
* Proven experience in Clinical Drug Development as a development or drug safety physician, including at least 2 years in drug safety (e.g., safety signalling, risk management, and mitigation).
* Strong medical knowledge with expertise in safety surveillance, and a thorough understanding of clinical, translational, and mechanistic data, particularly regarding the clinical safety implications of preclinical data.
* Proven ability to recognize, anticipate, and proactively communicate safety issues.
* Solid understanding of regulatory requirements for investigational products, including ICH, 21 CFR, EU GVP, and JP regulations.
* Established track record in the strategic development and implementation of clinical safety assessments during early drug development.
* Skilled at driving decision-making and influencing stakeholders within a matrix environment.
* Effective under pressure in fast-paced, high-demand environments, with the ability to adapt quickly to changing priorities.
* Strong leadership, strategic thinking, interpersonal, and communication skills, with the ability to clearly and concisely present data, strategies, and risk assessments to diverse audiences.
* Demonstrated enterprise mindset with the ability to collaborate across functions and levels.
Preferred Experience
* 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.
Education
* Advanced scientific degree (MD, PhD, PharmD) required, MD preferred or equivalent.
Working Environment
* The position is permanent full-time based in the UK.
* This position follows our hybrid working model. Role requires a blend of home and minimum of 1 day a quarter in office. Flexibility may be required in line with business need. Candidates must be located within a commutable distance of the office.
* Infrequent domestic or international travel may be required, depending upon project support needs.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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