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| Hiring Company | アストラゼネカ株式会社 |
| Location | Tokyo - 23 Wards |
| Job Type | Permanent Full-time |
| Salary | 14 million yen ~ 20 million yen |
【求人No NJB2376484】
Job Description
Cell Therapy Field Clinical Advisors (FCAs) are part of the Global Cell Therapy Clinical Operations team and play a critical role in the successful execution of cell therapy clinical trials・driving recruitment retention and safety management while enabling early insight generation. FCAs focus on clinical study protocol expertise and education optimizing the patient journey and cell therapy pipeline engagement. The role requires close collaboration with other CTCO Functions Clinical Development and Medical Affairs across multiple indications and business units to advance AstraZeneca’s diverse cell therapy portfolio.
Typical Accountabilities
Scientific Expertise and Education
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・Pipeline Mastery at Scale: Build and continuously maintain deep knowledge of AstraZeneca’s cell therapy pipeline across multiple indications and assets.
・Recognized Thought Leadership: Establish and sustain highest level scientific and medical expertise in cell therapy; recognized internally and externally as a go to expert shaping guidance training and best practices for assigned protocols and sites
・Strategic Portfolio Communication: Lead site facing and expert stakeholder communications that clearly convey AstraZeneca’s cell therapy strategy portfolio breadth and product differentiation; ensure consistent compliant messaging across regions.
・Initiative Ownership and Execution: Design lead and implement high impact local initiatives with trialists and key experts to support R D or study implementation aligned with GPT Global R D and Country Medical Affairs; track outcomes and scale successful approaches.
・Education Gap Identification and Closure: Systematically assess educational needs across owned sites deliver advanced protocol training and escalate patterns to Global Clinical Development with recommendations for enterprise level solutions.
・Insight Generation and Influence: Capture synthesize and deliver actionable field insights (feasibility operational bottlenecks patient pathways) to global and local stakeholders; drive early risk identification and influence protocol/process adjustments.
Clinical Trial Support
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・Advanced Education and Readiness: Lead delivery of SIV content; provide advanced protocol education and competency based staff training to ensure readiness compliance and consistency across sites and indications. Drive patient selection quality safety management and site specific action plans; deliver measurable improvements in start up timelines and protocol adherence
・Recruitment and Retention Performance: Implement targeted protocol education (e.g. inclusion/exclusion criteria application etc.) to uplift enrolment rates reduce screen failures and minimize attrition.
・Issue Triage Escalation and Risk Mitigation: Serve as the primary field point for protocol and clinical issues; triage and escalate appropriately drive root cause analysis and implement corrective/preventive actions to reduce deviations and data queries.
・Structured Compliant Scientific Exchange: Lead timely high quality scientific and medical communications with trialists and internal partners ensuring alignment with compliance policies and legal requirements; standardize messaging and capture learnings for reuse.
・Insight Loop and Continuous Improvement: Systematically capture site level insights; synthesize trends for study teams and cross functional stakeholders influencing protocol/process adjustments and scaling proven practices.
Operational
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・Cross functional orchestration: Lead coordinated delivery with CTCO Functions Clinical Development Medical Affairs Supply/Logistics Patient Operations and Country Ops to ensure rapid reliable service to internal stakeholders and study sites.
・Portfolio coverage and resiliency: Provide proactive coverage for other FCAs and high priority sites; implement standardized playbooks to maintain continuity of operations during surges vacations or escalations.
・Regulatory and policy stewardship: Maintain current knowledge of local regulations guidelines codes of practice and AstraZeneca policies relevant to Clinical Development; translate requirements into practical site actions and support inspection readiness.
・External scientific engagement: Attend and contribute at relevant scientific meetings and conferences; synthesize takeaways into concise briefs and recommendations for study teams and operational processes.
・Innovation sourcing and scaling: Build relationships with industry leaders and ecosystem partners; identify pilot and scale innovations (e.g. workflow tools logistics optimizations patient support solutions) that improve cycle times quality and site experience.
Cross Functional
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・Global workstreams: Provide country specific field insights and subject matter expertise to priority global initiatives; review/shape core strategies and deliverables to enable scalable locally compliant adoption.
・Medical Affairs: Partner on scientific strategy congress/education plans and field content; ensure accuracy balance and governance compliance across materials and training.
・Commercial (within governance): Coordinate through approved interfaces to align on market dynamics and objectives
・Evidence and insights: Elevate actionable field signals to inform global research strategy and lifecycle plans; ensure traceability from signal to decision.
・Governance: Operate within AZ policies/SOPs and local regulations
Impact
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・Operational velocity and quality: Directly improve speed quality and consistency of AstraZeneca’s cell therapy trials・reducing cycle times elevating protocol adherence and accelerating patient access to innovative treatments.
| Minimum Experience Level | No experience |
| Career Level | Mid Career |
| Minimum English Level | Business Level |
| Minimum Japanese Level | Native |
| Minimum Education Level | Bachelor's Degree |
| Visa Status | Permission to work in Japan required |
Essential
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・Education: Bachelor’s degree in a health related field required; advanced degree (PharmD PhD MSc NP/PA MD/RN) preferred.
・Experience: 5+ years in clinical research or field facing roles within oncology/hematology or advanced therapies; direct cell therapy experience strongly preferred.
・Technical Skills: Concentrated understanding of GCP clinical trial operations and cell therapy patient journey
・Collaboration and Communication: Excellent stakeholder management presentation and training skills; ability to translate complex protocols into practical site actions.
・Travel: Willingness to travel regionally/nationally and internationally to support sites and program needs.
・Patient and site centric mindset・with a bias for action and problem solving.
・Data informed approach・to identify trends risks and opportunities for operational improvement.
・Agility・to support multiple studies and indications in a dynamic portfolio environment.
Desirable
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・5・8+ years in clinical research or field facing roles ideally in oncology/hematology/immunology/rare disease and/or advanced therapies; direct CAR T/Cell Therapy experience strongly preferred.
・Prior ownership of site performance metrics・
・Prior account leadership and existing relationships in C/D suites
・Proven ability to lead trainings influence without authority and translate complex protocols into pragmatic site actions adept at concise escalation and stakeholder alignment.
・Prior large pharma experience in cell therapy
・Scientific training and/or protocol training expertise
| Job Type | Permanent Full-time |
| Salary | 14 million yen ~ 20 million yen |
| Work Hours | 09:00 ~ 17:15 |
| Holidays | 【有給休暇】有給休暇は入社時から付与されます 【有給休暇】 初年度 4~16 日 ( 1 か月目~ ) 入社月により付与日数が… |
| Industry | Pharmaceutical |
| Company Type | International Company |