Global Precision Medicine Lead

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.
  
  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.
  
  Global Precision Medicine Lead
About Astellas: At Astellas we can offer an inspiring place to work and a chance to make your mark in doing good for others. Our expertise, science and technology make us a pharma company. Our open and progressive culture is what makes us Astellas. It's a culture of doing good for others and contributing to a sustainable society. Delivering meaningful differences for patients is our driving force. We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners. 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. Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity. We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership. Our aspiration is to bring the best brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit. The Opportunity