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Global Clinical Development Strategy Expert （GCDSE）

年収：1100万～ 1800万

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部署・役職名	Global Clinical Development Strategy Expert （GCDSE）
職種	その他臨床開発
業種	医薬品メーカー
勤務地	東京都
仕事内容	Global Clinical Development Strategy Expert (GCDSE) The GCDSE provides global clinical and scientific leadership for Sanofi Vaccines, overseeing the Clinical Strategy, Development Plans (CDPs), and protocols to align with the Target Product Profile, IEGP, and project strategy. They ensure global consistency and regional relevance while serving as a subject matter expert in the relevant disease area. As the leader of the Clinical (or Extended Clinical) Team, the GCDSE represents clinical perspectives in Global Project Teams (GPTs), leads protocol discussions with regulatory agencies, advisory boards, and public health institutions, and ensures consistency in global interactions. They collaborate closely with R&D, medical affairs, and country teams, overseeing clinical components of CTDs and liaising with Regulatory Affairs. Ethics and Safety The GCDSE ensures subject safety and ethical integrity in clinical trials, adhering to GCP and executing CDPs within optimized timelines. They also provide medical monitoring and address protocol-related questions, collaborating with study management and pharmacovigilance teams. ■ CDP Implementation ・Leads clinical study implementation from development through commercialization per ICH-GCP. ・Collaborates with GME/PMSL and Clinical Study Management for site selection, ensuring alignment with CDP. ・Works with Clinical Ops, GBS, and others to ensure study feasibility and GCP compliance. ・Oversees global protocol and amendment development, safety data quality, interim analyses, and regulatory documentation. ・Maintains consistency in key meetings (e.g., investigators, IDMC, safety boards). ・Supports alignment with other GCDSEs for regional CDP implementation. ■ Project Planning and Reporting ・Acts as or supports the clinical representative in GPTs. ・Reports project status and ensures timely deliverables. ・Informs timing, budget, and resource planning based on clinical assumptions. ■ Regulatory Support ・Leads clinical input for regulatory submissions. ・Develops and reviews clinical content of study documents and safety processes. ・Reviews and approves clinical sections of CTD/local dossiers. ・Responds to Health Authority queries and coordinates consistent communications. ・Attends relevant regulatory and CTD meetings. ・Engages with regulatory bodies during scientific and data review discussions. ■ Epidemiology ・Provides clinical support for epidemiological studies led by the platform. ■ Medical Monitoring ・Ensures subject safety and acts as the medical expert (under physician supervision if needed). ・Supports audits/inspections and proactively addresses issues. ■ Medical/Scientific Data Interpretation and Communication ・Leads data interpretation and review of study reports and regulatory documents. ・Engages internal/external stakeholders in result analysis and strategy updates. ・Participates in CRSF and provides clinical input to publication planning and scientific communication. Publications：・Contributes to iSCP and PWG/PSC as applicable. ・Co-authors and presents study findings at scientific meetings. Scientific Communication and Stakeholder Engagement：・Presents to internal/external audiences, supports investigator networks, and coordinates public health communications. ・Shares relevant scientific/medical updates with cross-functional teams. ・Participates in due diligence for internal/external vaccine candidates and builds stakeholder relationships. ・Supports media and product launch events from an R&D perspective. Regional Activities：・Participates in advisory boards, scouting, and regional intelligence gathering. ・Reviews competitor pipelines and supports local KOL engagement. ■ Study Execution and Logistics ・Provides clinical input to regional regulatory strategy and validates medical content. ・Coordinates responses to authorities and supports study execution as a country/regional monitor. ・Ensures global strategies are locally implemented. ・Liaises with GCDSEs for concept documents, SAP alignment, safety oversight, and IB development. ・Writes protocols and CSRs for regional studies. ・Shares results with investigators and stakeholders post-study closure. ■ Additional Accountabilities ・Maintains up-to-date training on ICH-GCP and SOPs. ・Ensures high ethical standards and confidentiality. ・Mentors new hires and supports process improvement initiatives. ■ Job Context / Major Challenges Interface Between Science and Operations Translates TPPs into feasible CDPs by balancing scientific, resource, and feasibility factors. Requires deep therapeutic knowledge, cross-functional collaboration, and strategic thinking. Team Leadership Leads clinical teams across cultures, requiring strong leadership, communication, and team motivation skills. ■ Requirements Education/Experience：・MD, PhD, or PharmD (preferred: Pediatrics/Internal Medicine with immunology/infectious disease experience). ・3–5 years industry experience or 5+ years in academic clinical trials or equivalent in public health/epidemiology. ・Track record of scientific productivity and data interpretation. ・Strong communication, planning, and problem-solving skills. ・Fluency in English and local language; understanding of local clinical/regulatory environment. ■ Certifications ・MD or PhD preferred. ・Completion of an approved residency training program or equivalent.
応募資格	■Selling Point 1. Global Leadership: Spearheads global clinical strategy and protocol development, ensuring consistency and scientific excellence across regions. 2. Cross-Functional Expertise: Acts as the clinical voice in global project teams, regulatory discussions, and public health engagements, bridging science, operations, and strategy. 3. Ethics & Innovation: Drives high-standard, ethically sound clinical trials while contributing to global vaccine advancement through medical monitoring and data-driven insights.
アピールポイント	自社サービス・製品あり外資系企業女性管理職実績あり従業員数1000人以上シェアトップクラス年間休日120日以上産休・育休取得実績あり教育・研修制度充実
受動喫煙対策	その他「就業場所が屋外である」、「就業場所によって対策内容が異なる」、「対策内容は採用時までに通知する」などの場合がその他となります。面接時に詳しい内容をご確認ください
更新日	2025/04/22
求人番号	4571232

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