Pre-Clinical Safety Toxicologist, Associate Director, Applied Safety

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.

The Opportunity: As the Pre-Clinical Safety Toxicologist – (Associate Director, Applied Safety) you will have the opportunity to support the progression of multiple therapeutic moieties, including small molecules, large molecules, and cell and gene therapy programs. As a member of Applied Research and Nonclinical Safety, you will play a critical role in developing, implementing and executing the nonclinical and clinical strategies for these programs, as well as supporting the safety of marketed products. You will closely partner with internal scientists, clinicians and external experts to advance transformational treatments for patients. This position reports into the Senior Director, Applied Safety and is based in the UK.

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.

Key Responsibilities:

• Representing the toxicology function as a subject matter expert on drug discovery and development project teams and provide guidance on strategies for safety characterisation, prioritisation and advancement of drug candidates.
• Planning and executing overall safety assessments as a project toxicologist.
• Leading discussions on the design, execution, data analysis and interpretation of toxicology studies.
• Monitoring and managing studies performed at CROs.
• Communicating study results and their relevance to program teams, collaborators, senior management and regulatory agencies.
• Review and draft relevant sections of regulatory submission documents such as CTAs, INDs, IBs and BLAs.
• Supporting post-marketing information updates from non-clinical safety perspectives and provide safety data and rationale in post-marketing clinical trials, if necessary.
• Collaborating with various internal functions, CROs, academic and analytical laboratories to ensure the conduct and completion of high-quality studies and timely progression of programs.

Essential Knowledge & Experience:

• Significant number of years of experience in toxicology and/or regulatory science working in the pharmaceutical and/or biotech industry.
• Experience in the design, conduct and interpretation of GLP and non-GLP nonclinical studies.
• Strong understanding of drug discovery, development and regulatory processes.
• Demonstrated experience supporting drug discovery/development programs across important milestones such as first-in-human dosing.
• Excellent critical thinking and scientific skills, and a demonstrated ability to analyse, interpret, and clearly communicate complex results.
• Proven ability to work effectively and collaboratively on cross-functional teams, including leading and spearheading projects internally and externally.
• Excellent oral and written communication skills.

Preferred Experience:

• Experience working on cell and gene therapy programs.
• Experience working on biologics and ADCs.
• Experience working on rare disease indications.

Education/Qualifications:

• PhD in Life Science area (Toxicology, Biochemistry, Cell Biology, etc)
• Board Certification in Toxicology (DABT preferred)

Additional Information:

This is a permanent, full-time position. This position is based in the UK. This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per quarter in our local office. Flexibility may be required in line with business 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.