Description
Diagnostic Operations Manager
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.
The Opportunity
Please note, this is a Scientist position and is not laboratory-based.
As part of the Precision Medicine and Diagnostics team, you'll focus on the co-development of companion diagnostics alongside drug programs and support diagnostic testing for patient selection and stratification throughout all phases of clinical development.
In your role as Diagnostic Operations Manager, you will oversee diagnostic testing at external central laboratories for patient eligibility and biomarker stratification in clinical trials. You'll ensure compliance with regulatory and quality standards, manage relationships with external vendors, coordinate biosample logistics, and collaborate closely with study teams to ensure accurate diagnostic testing and reliable data management.
Hybrid Working
At Astellas we recognize 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 optimize 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
* Oversee diagnostic testing at external central laboratory operations across 4–8 clinical trials within 2–4 drug programs, depending on the complexity and scope of diagnostic activities. This includes ensuring assay validation, laboratory accreditation, and quality management system compliance, while implementing corrective actions when needed.
* Collaborating with clinical and diagnostic teams on vendor assessment, selection, contracting, and execution of laboratory services, while maintaining a matrixed relationship with colleagues across Global Development Teams such as Precision Medicine & Diagnostic Leads, Alliance and Bio sample Management, Clinical Science, Data Science, Project Management, Regulatory Affairs, and Translational Medicine.
* Serving as the primary point of contact for study teams and companion diagnostic partners, managing laboratory vendors to ensure high-quality biospecimen analysis that meets contracted testing specifications.
* Overseeing bio sample logistics from clinical sites to central laboratories, ensuring sample integrity, traceability, and adherence to timelines, and troubleshooting issues related to collection, processing, testing, storage, or shipment in close collaboration with vendors, clinical operations, and diagnostic partners.
* Working with study teams and external vendors to develop diagnostic monitoring and communication plans and ensuring accurate design of eCRFs and data transfer specifications; supporting data management with diagnostic data reconciliation for central lab outputs.
* Participating as a member of Precision Medicine & Diagnostics project teams supporting drug development and clinical trials and reporting directly to the Global Head of Precision Medicine and Diagnostics.
Essential Knowledge & Experience
* In-depth knowledge of biomarker testing techniques such as immunohistochemistry, immunofluorescence, and DNA/RNA-based assays.
* Skilled in managing vendors, negotiating contracts, and overseeing human biosample logistics in the context of clinical trials.
* Experienced with Laboratory Information Management Systems (LIMS).
* Demonstrated success in leading cross-functional teams and handling multiple priorities in a dynamic, fast-paced setting.
* Effective collaborator with the ability to communicate findings clearly to both technical and non-technical audiences.
Preferred Experience
* Experience in developing diagnostic tests under Design Control, in accordance with FDA Quality System Regulations and other international regulatory requirements (e.g. EU, Japan, China).
* Familiarity with FDA Investigational Device Exemption (IDE) and EU In Vitro Diagnostic Regulation (IVDR) processes for clinical studies.
Education
* BSc, MSc or PhD with demonstrated experience in lab operations and clinical research or equivalent.
Additional Information
* This is a permanent, full-time position 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 Addlestone office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.
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.