Precision Diagnostics Development (PDD) within AstraZeneca focuses on matching medicines to those patients who will benefit from the Companion Diagnostic (CDx) assays that align with the drug development process and enable personalized healthcare approaches within our clinical portfolio. 

PDD China team will drive China Diagnostic strategy and technque development, Diagnostic testing lab set up, Diagnostic data delivery and CDx partnership to enable AstraZeneca new drug development and registration in China market.

The Executive Director, Head of PDD China is accountable for building China Dx strategic capability and leadership to ensure PDD Dx being fully aligned with R&D China clinical study design. The role holder will lead Dx/CDx strategy alignment across local and global functions to enable high quality of Dx assay development and readiness by either transfer Global assay to a lab in China or develop local assay with appropriate and acceptable concordance to the reference assay to enable patient enrolment in the clinical trial. The role holder will also ensure quality assurance of AstraZeneca’s external diagnostic partners.

The role requires a strong Dx strategic knowledge, broad expertise on Dx regulation, strong knowledge on disease and technologies, great leadership and communication capability, strong trouble-shooting skill, and collaborative spirit to ensure a close engagement internally and strategic collaboration externally.

The Head of PDD China will work closely with senior leaders in PDD Global and R&D China to deliver Dx/CDx strategy for R&D China business. The role holder is accountable for ensuring that the role and responsibilities are delivered demonstrating behaviors and values aligned to AstraZeneca Code of Conduct and supporting policies, standards and procedures, including accountability for compliant management of Safety, Health and Environment. 

Typical Accountabilities:

• Provide strategic leadership for the specific diagnostic discipline. Communicate a clear and inspirational vision based on a long-term view of the capability.
• Ensures delivery of sub-team objectives in line with wider business objectives.
• Create and implement strategy for the delivery of diagnostics biomarkers and tests for use in clinical trials, regulatory submission and commercialisation based on a long-term view of internal project demand and the evolving external regulatory and healthcare environment.
• Attract, recruit, and retain top talent and technical expertise. Lead performance management and personal development of group members through coaching, mentoring, and motivating.
• Plans sub-team resources according to business targets.
• Provide strategic advice for analytical validation and delivery of validated diagnostic tests for use in clinical trials, regulatory submissions and commercialisation according to international regulatory standards.
• Work collaboratively with the PDD function and other stakeholders to provide diagnostics strategy and solutions, working across boundaries and courageously addressing issues which may inhibit effective collaboration.
• Apply external intelligence and perform strategic evaluation on emerging Diagnostic trends in the light of project demand, competitor knowledge and scientific understanding.
• Ensures excellence and sets standards for diagnostic projects within own sub-team.
• Monitor and ensure compliance with all AstraZeneca Policies and Standards and immediately address instances of non-compliance.  Deliver ethical and compliant management of Safety, Health and Environment within the group and on behalf of the function as required.
• Directs or leads external collaborations.
• Contribute to the overall performance of the function as a leadership team member, driving strategy and organisational infrastructure improvements.

Education, Qualifications, Skills and Experience:

Essential

• PhD or equivalent experience in a relevant subject
• Broad science and technology knowledge and background. Recognised specialist in field.
• Proven leadership ability, global team working and line management experience.
• Must demonstrate excellence in the recruitment, retention, development and motivation of groups of highly qualified Precision Medicine Lead and Dx Scientists
• Experience in a similar role within pharmaceutical or diagnostics industry
• Able to act as a representative for the function within AstraZeneca interacting effectively with key stakeholders and senior leaders, understanding key AZ objectives across multiple specialist areas.
• Able to represent AstraZeneca externally in interactions with regulatory authorities (even to the level of National Medical Products Administration communication) and at top level scientific meetings.
• Successful track record in the execution of diagnostic testing with diagnostic companies through partner contracts
• Experience of delivering and working to good clinical practice (GCP) and other regulatory standards across the major markets
• Good Business acumen – including HR, finance, legal, purchasing, and IP
• Good English communication skill.

Skills & Capabilities:

• Excellent interpersonal, written and oral communication skills, including enhanced presentation skills.
• Strategic influencing skills (experienced in stakeholder management at senior leadership level) whilst maintaining independent and objective views.
• Proven teamwork and collaboration skills – confident and assertive but willing to listen and to seek and learn from the views of others.
• Highly-developed cultural sensitivity as work involves being part of global teams
• Excellent interpersonal, written and oral communication skills, including enhanced presentation skills.
• Strategic influencing skills (experienced in stakeholder management at senior leadership level) whilst maintaining independent and objective views.
• Proven teamwork and collaboration skills – confident and assertive but willing to listen and to seek and learn from the views of others.
• Highly-developed cultural sensitivity as work involves being part of global teams

Desirable

• Experience in companion diagnostic development and related molecular and or tissue-based biomarker technology is strongly preferred.
• Track record of providing diagnostics support to project teams and generating data required for regulatory submissions.
• Major experience in drug development and different therapeutic areas
• Experience in leading scientific organizations and driving cutting edge science.
• Proven track record of working with third parties, both commercial and academic
• Understanding of related areas e.g., payer insight, diagnostic partnering, regulation of drugs and linked diagnostics, policy considerations, ethical and legal aspects
• Strategic thinking on Diagnostics strategy making under China circumstances.