职位描述
RESPONSIBILITIES:•Develops companion diagnostic solutions to enhance current or establish new technologies across AstraZeneca’s portfolio•Transfers diagnostic assays in laboratory testing networks to enable delivery within a clinical study setting•Provide Diagnostics consultation to support new drug launch readiness and marketing promotion•Preparation and review of documentation•Technical troubleshooting of the diagnostic assay•Preparation of study reports and their presentation at study team meetings•Working within study, diagnostic and commercial teams to deliver data for registration of NDA and CDx, as well as commercial business•Lead innovative diagnostic science to fulfil Precision Medicine approaches.•Across boundaries in the scientific area(s) of expertise that will enable drug development projects and diagnostics labelling.•Build and maintain a knowledge of current and emerging diagnostic assay technologies in area of expertise.•Drive continuous improvement in the scientific area(s) of expertise, aligned to Precision Medicine strategic objectives of increasing project success, adding value to projects and delivering better medicines to patients.•Align with the commercial teams to identify barriers to diagnostic testing and create data to eliminate barriers.•Identify new technologies and generate data for market adoption.•Be accountable for the time, cost and quality of agreed deliverables.•Provide updates on the progress, risks and opportunities of the agreed deliverables to the appropriate governance bodies for review, challenge and issue resolution.•Takes on small supervisory or skills transfer / training roles•Monitor and ensure compliance with all AstraZeneca Policies and Standards, and local law/regulation, and immediately address instances of non-compliance. •Significant supervisory, team leader or group leader accountability often as formal line manager. Attract, recruit, and retain top talent and technical expertise. Lead performance management and personal development of group members through coaching, mentoring, and motivating. Ensures delivery of team objectives in line with business objectives.•Lead a team to be accountable for managing Diagnostics lab or CRO via developing standard process & system, risk-based management and establish partnership for Diagnostics testing.•Manage molecular diagnostics testing lab related documents for clinical studies.•Internal communication with different R&D functions for gap identification and solve issues.REQUIRMENTS;•Bachelor or Master degree or equivalent experience in a relevant scientific subject.•Experience of working in R&D Diagnostics business•Demonstrable experience of analytical diagnostic assay validation and use in a clinical testing setting.•Ability to communicate with stakeholders for study updates, testing progress through oral presentations and progress reports.•Experience of working with partners to drive timely and successful outcomes, through effectively working across internal and external boundaries.•Experience of working within a global team.•Experience of working with regulatory authorities.•Exposure to working within a technically regulated environment.•Experience of working in a clinical lab. Familiar with quality ensuring system and processes.•Respected in teams for understanding and insight of specific discipline and keeps up with current advances.•Works well under supervision, designing, executing and interpreting tasks.•Can present and communicate data to teams.•Good knowledge of clinical trial sample biomarker testing procedures, and applicable laboratory testing regulations and quality systems (e.g., GCP, CAP, CLIA, etc)•Will ensure compliance with local and global company policies for self and colleagues.•Knowledge of, and enthusiasm for, the aims and objectives of personalised healthcare.•Willingness to travel both nationally and internationally.
