Associate Principal Scientist II Full-time

Job Title

Diagnostic Development Scientist

Typical Accountabilities

Diagnostic development and innovation: Delivery of diagnostic testing to clinical studies as agreed with project leaders including: diagnostic test establishment in partner laboratories, monitor diagnostic test data for quality control, provide scientific troubleshooting when necessary and preparation of study reports with presentation at appropriate meetings; Lead the delivery of diagnostic data work packages to enable regulatory submission and approval inclusive of studies to enable market adoption and life cycle management; Build and maintain a knowledge of current and emerging diagnostic assay technologies to fulfill precision medicine approaches.

Strategic planning and execution: Make milestone-driven plans including measurable outcome success, criteria, risk/mitigation plans; Regularly update scenarios and contingencies based on evolving data and operational realities; Prioritize hypotheses and studies for maximum impact and resource efficiency, balance near-term/long-term goals across multiple programs; Integrate input from clinical, data sciences, regulatory, CROs, central labs etc. to drive consensus and accountable delivery; Globally planning considering reginal requirements and harmonize global operational plans to enable consistent, timely data generation across geographies; Proactively propose pivots or novel technologies to de-risk development and accelerate decision-making.

External vendor leadership: Select, onboard, and manage CROs, central labs, bioanalytical partners, and data vendors; Be accountable for scopes, budgets, timelines, and quality metrics; ensure assay transfer, validation documentation, and ensure compliance with all AstraZeneca Policies and Standards, and local law/regulation, and immediately address instances of non-compliance.

Translational and biomarker strategy and delivery: Define and own program-level hypotheses linking mechanism to patient outcomes; Translate nonclinical and human evidence into clinical endpoints, dose/range selection, and proof-of-mechanism/ proof-of-concept; Lead end-to-end biomarker planning (target engagement, PD, prognostic, predictive, safety); Select platforms, drive fit-for-purpose validation, and ensure robust sample lifecycle and data QC.

Global communication and collaboration: Provide updates on the progress, risks and opportunities of the agreed deliverables to the appropriate governance bodies for review, identify challenges and issue resolution; Communicate clearly to global stakeholders, governance bodies, and external partners/KOLs. Coordinate biomarker operations, harmonize assay deployment, sample flow, and data privacy.

Project management: Manage projects across internal and external partners in a global multi-disciplinary environment by applying scientific, technical and operational expertise. Identify opportunities, propose solutions and work across boundaries in the scientific area(s) of expertise that will enable drug development projects and diagnostics labeling. Be accountable for the time, cost and quality of agreed deliverables.

Education, Qualifications, Skills and Experience

Essential

• PhD, MD, or PharmD in a relevant field (e.g., human genetics, molecular/cellular biology, immunology, neuroscience, metabolic disease) with 4–6+ years of industry experience; or MS with 8–10+ years. Fluent English communication and presentation.
• Demonstrable experience of analytical diagnostic assay validation and the use in a clinical testing setting.
• Ability to communicate with stakeholders for study updates, testing progress through oral presentations and progress reports
• Knowledge of clinical trial sample biomarker testing procedures, and applicable laboratory testing regulations and quality systems (eg, GCP, CAP, CLIA, etc)
• Proven experience of delivery and use of data for diagnostic projects – including quality control, test data monitoring and troubleshooting
• Experience of working with diagnostic partners to drive timely and successful outcomes, through effectively working across internal and external boundaries.
• Experience of working within a global team.
• Knowledge in Tissue diagnostic technologies (IHC, FISH, Dual-ISH, etc.)

Skills & Capabilities

• Good interpersonal skills and ability to act as an ambassador for Precision Medicine internally and externally
• Ability to interact successfully with multiple customers across functional boundaries
• Ability to work independently, designing, executing and interpreting tasks
• Ability to identify risks and escalate appropriately
• Can identify and address critical issues in the context of strategic direction
• A confident team player who is assertive but willing to listen and learn from the views of others
• Ability to influence within own discipline and apply constructive challenge
• Excellent organisational skills, with the proven ability to deliver high quality work under pressure and against tight timelines
• Knowledge of, and enthusiasm for, the aims and objectives of personalised healthcare
• Willingness to travel both nationally and internationally

Desirable

• Pharmaceutics or diagnostic company working experience for clinical trials, and CRO lab management experience is highly desired.
• Experience of designing and executing translational/biomarker strategies in low-prevalence indications, including natural history, surrogate endpoints, and patient-centric measures.
• Experience of leading projects within a diagnostic or drug development organization.
• An understanding of drug and companion diagnostic assay co-development, partnering, commercialization and experience working in early and late phase projects
• Knowledge of scientific literature with deep understanding in diagnostic related areas demonstrated through publications in peer reviewed journals.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.