Early Development Global Safety Officer

General Information

Job Advert Title Early Development Global Safety Officer Location United Kingdom Function/Business Area Regulatory Affairs Employment Class Permanent

Description

Early Development Global Safety Officer
About Astellas:
At Astellas we are a progressive health partner, delivering value and outcomes where needed.
We pursue innovative science, focusing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.
We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.
Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.
We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes.
Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.
Opportunity:
Reporting to the Team Leader for Early Development Medical Safety and serving on the Asset Team, the Early Development Global Safety Officer (EDGSO) is 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.
Working closely with the Asset Team Toxicology expert, the EDGSO contributes clinical expertise to the Candidate Nomination Declaration Committee (CND-C) process by informing GLP toxicology study design, assessing non-GLP toxicology and pharmacology data, and considering the projected product target and mechanism of action. During Phase 0, the EDGSO provides predictive clinical safety insights, interprets non-clinical risks, and defines risk assessment and mitigation strategies to guide entry into clinical development. Once in development, the EDGSO acts as drug safety lead on the Asset Team through PoC and, as compound lead within Pharmacovigilance, serves as the primary liaison with the PV team to ensure communication of safety messages and implementation of safety strategies.
Hybrid Working:
At Astellas we recognise 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 optimise 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.
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 is a permanent full-time position 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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