Global Precision Medicine Lead About Astellas: At Astellas we are a progressive health partner, delivering value and outcomes where needed.
We pursue innovative science, focussing 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: In this role, you will develop and implement biomarker and diagnostic strategies across drug development programs, aiming to create tailored therapies that enhance patient outcomes.
You will guide companion diagnostics from development through approval, in partnership with external diagnostic collaborators.
Your strong expertise in applied biomarker research, companion diagnostics, and a drive to deliver innovative solutions are essential.
Key Activities for this role: Develop and execute precision medicine and diagnostic strategies for clinical programs in oncology and other therapeutic areas.
Develop clinical studies, focusing on patient stratification, and biomarker testing, and contribute to study and regulatory documentation.
Enhance early drug development by defining the relationship between biomarkers, drug efficacy, and safety.
Evaluate and select diagnostic technologies and partners, integrating companion diagnostics with drug clinical studies.
Ensure compliance with regulatory requirements and support data publication from precision medicine research.
Essential Knowledge & Experience: Proven experience and proven track record in the application of biomarkers and precision medicine in drug development at a biotech/pharmaceutical company.
A solid understanding of clinical development strategies, clinical study design, and companion diagnostic development is required.
Experience in leading the implementation and interpretation of biomarker /diagnostic testing in clinical studies is required.
Experience working in cross-functional matrixed work environments is essential.
Excellent communication, project management, and leadership skills.
Preferred Experience: Experience in the registration of companion diagnostics and pharmaceuticals is preferred.
Strong knowledge of the process and global regulations for companion diagnostic development, approval and launch.
Education: Advanced science degree (PhD, PharmD or MD) in a relevant scientific field.
Additional Information: This is a permanent full-time position.
This position is based in our Addlestone office in the United Kingdom.
This position is 100% home/remote based.
This role forms a part of Information Technology.
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.