Mission: 日本のオンコロジー領域において、コンパニオン診断を含む遺伝子検査の最適な導入を主導し、保険償還、病理検体確保、運用実装、検査会社・学会連携を統合することで、治療アクセスを最大化する。 Job Description: 関係部門と協力しながら、がん種別の診断薬の課題に応じて、導入戦略を設計・実装 - 病理検体(FFPE/血中DNA等)とワークフロー最適化、TAT短縮、失敗率低減、施設整備のための計画を作成 新規診断薬の保険償還及び市場適合性の評価、普及を加速させるための計画、代替プラットフォーム選定業務をリード、または関与する 検査会社、検査関連の学会 など外部ステークホルダーの1次窓口としての対応 Requirements: Mandatory 製薬・検査会社・医療機関のいずれかでオンコロジー領域の実務経験 5年以上; 以下の要件から複数の該当項目があること 遺伝子検査(NGS/PCR)またはIHC/ISH/病理運用の基礎知識と、現場実装・改善の主導経験 学会/委員会/検査会社/病院との折衝・合意形成スキル 申請/薬事・品質/コンプライアンスの基礎理解 日本語スキル(ネイティブ相当) Nice to Have コンパニオン診断(CDx)申請/審査対応、LDTからIVD移行、腫瘍パネル(FFPE/液状生検)の導入経験 償還取得や費用対効果評価の実務、がんゲノム医療中核拠点/連携病院での運用知見 病理検体前処理、デジタルパソロジー、レポート解釈支援、QCS/外部精度管理の知見 複数プラットフォーム(PCR、NGS、IHC、FISH、ctDNA、HRD、MSI/TMB)の実装経験、KOLネットワーク マトリクス環境のPM経験 英語スキル(Globalとの折衝ができるレベル) Competency: 問題構造化と実装ドリブンの遂行力、現場定着まで自分でやり切る姿勢 ステークホルダー・マネジメント/交渉力、データドリブン意思決定(品質/KPI設計) 高いコンプライアンス意識と患者志向、医療現場への共感 Location Osaka or Tokyo
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