Clinical Program Manager

<p>At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.<br /> </p><p>Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.<br /> </p><p>We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.<br /><br /><b>Job Description</b><br /> </p><div><h1>【ENGLISH】</h1><h2>Position Overview</h2><ul><li>This position is responsible for the successful management of post-marketing surveillance (PMS) across various therapeutic areas, in partnership with global/regional Clinical Operations teams and other functions, under the supervision of the Associate Director of Japan Clinical Operations (ClinOps).</li><li>Clinical Operations is responsible for the worldwide execution of all Phase I–IV clinical trials across all Gilead therapeutic areas. ClinOps ensures that all trials are conducted in accordance with applicable SOPs, company policies, and regulatory guidelines, providing timely and high-quality clinical data to support global registration and commercialization.</li><li>The Clinical Operations Late Phase team is responsible for the implementation of PMS, preparation of J-PSR, and re-examination applications, and works closely with the PMS Manager to ensure GPSP-compliant activities.</li><li>The CPM oversees and is responsible for the successful execution of one or multiple studies/programs, including financial responsibility.</li><li>The CPM manages study resources through continuous assessment and optimal deployment to support a flexible “One Ops” workforce.</li><li>The CPM participates in Clinical Operations and cross-functional organizational initiatives and may serve as a Business Process Owner (BPO) and/or Subject Matter Expert (SME), promoting innovation and best practices across ClinOps.</li></ul><h2>Example Responsibilities</h2><ul><li>Act as Post-Marketing Study Lead and serve as chairperson of cross-functional study management teams to manage all PMS activities in close collaboration with ClinOps, RWE, Patient Safety, Clinical Development, Regulatory Affairs, and Biometrics (Japan and global).</li><li>Provide input into short- and long-term therapeutic area and functional strategic and operational plans and support alignment and communication upon implementation.</li><li>Contribute to the development of PMS protocols (including PMS plans in the Japan Risk Management Plan) and CRFs in collaboration with Japan and global teams.</li><li>Support the Associate Director in PMDA negotiations by preparing responses to PMDA inquiries related to protocol and CRF design based on scientific rationale and PMS results.</li><li>Under the supervision of the Associate Director, lead CRO selection processes, including RFP preparation, CRO selection, and Work Order execution, in collaboration with Vendor Outsourcing and other relevant functions.</li><li>Oversee performance and quality of outsourced CRO activities.</li><li>Provide ongoing financial oversight of assigned PMS studies and programs.</li><li>Partner with cross-functional teams to manage and revise project timelines and budgets.</li><li>Ensure study quality and compliance with Work Orders, SOPs, protocols, and Japanese regulatory requirements.</li><li>Prepare training plans and deliver training to internal Therapeutic Specialists and CRO personnel.</li><li>Prepare PMS-related sections of J-PSR and re-examination reports in English and Japanese.</li><li>Manage audits and inspections by regulatory authorities or internal compliance groups.</li><li>Prepare TMF plans and manage document archiving.</li><li>Develop and maintain GPSP SOPs and provide required training.</li><li>Support other non-interventional studies and early-phase (Phase II/III) clinical trials as needed.</li></ul><h2>Requirements</h2><h3>Minimum Education &amp; Experience</h3><ul><li>BA/BS/RN with 8&#43; years of relevant experience<br /><b>or</b> MA/MS/PharmD/PhD with 6&#43; years of relevant experience</li><li>Minimum 5 years of PMS experience in pharmaceutical companies</li><li>At least 4 years of cross-functional study or project management experience</li><li>Experience with RFP development and CRO/vendor selection and oversight</li><li>Strong communication and influencing skills</li></ul><h3>Knowledge &amp; Other Requirements</h3><ul><li>Advanced knowledge of one or more disease or therapeutic areas</li><li>Full-cycle study management experience (start-up to close-out)</li><li>Knowledge of PMS planning and execution</li><li>Experience preparing J-PSR and/or re-examination dossiers</li><li>Basic knowledge of statistical analysis and data management for PMS</li><li>Thorough understanding of Japanese regulations, ICH guidelines, and GPSP</li><li>Strong Japanese and English communication skills (TOEIC ≥ 750)</li><li>Proven project management, leadership, and change management skills</li><li>Hands-on approach and ability to travel as required</li></ul><h1>【日本語】</h1><h2><b>Manager&#xff08;CPM&#xff09; Japan Late Phase</b><br /><b>グレード:</b> 29</h2><h2>ポジション概要</h2><ul><li>本ポジションは、日本の Clinical Operations&#xff08;ClinOps&#xff09;において、Associate Director の監督のもと、グローバルおよび日本の関係部門と連携し、複数の疾患領域における製造販売後調査&#xff08;PMS&#xff09;を成功裡にマネジメントする責任を担います。</li><li>ClinOps は、ギリアドの全治療領域における第 I 相から第 IV 相までの臨床試験および PMS を全世界で統括し、SOP、社内方針、規制ガイドラインに準拠した高品質かつ適時の臨床データ提供を担います。</li><li>Late Phase チームは、PMS の実施、J-PSR 作成、および再審査申請を担当し、GPSP に準拠した活動を関連部門と協働して推進します。</li><li>CPM は、単一または複数の試験・プログラムについて、財務責任を含めた遂行全体を統括します。</li><li>リソースニーズの継続的な評価および最適配置を通じて、「One Ops」体制を支援します。</li><li>ClinOps 内外の変革イニシアチブに参画し、BPO または SME としてプロセス改善やイノベーションを推進します。</li></ul><h2>主な職務内容</h2><ul><li>PMS スタディリードとしてクロスファンクショナルなスタディマネジメントチームを主導し、PMS 全体を統括します。</li><li>日本およびグローバル部門と連携し、PMS プロトコル&#xff08;日本版 RMP 含む&#xff09;および CRF の作成に貢献します。</li><li>PMS 結果および科学的根拠に基づき、PMDA 照会対応の準備を行い、AD を支援します。</li><li>RFP 作成、CRO 選定、ワークオーダー締結を含む CRO 選定プロセスを主導します。</li><li>CRO 委託業務の品質およびパフォーマンスを監督します。</li><li>PMS&#xff0f;臨床試験の財務、スケジュール、予算管理を行います。</li><li>SOP、プロトコルおよび規制要件を遵守し、試験品質を確保します。</li><li>社内担当者および CRO 向けトレーニングを企画・実施します。</li><li>J-PSR および再審査申請資料の PMS 関連部分を日英で作成します。</li><li>監査・査察対応、TMF 管理、GPSP SOP の策定および教育を実施します。</li><li>その他の非介入試験や、第 II&#xff0f;III 相試験の支援を行う場合があります。</li></ul><h2>応募要件</h2><h3>学歴・経験</h3><ul><li>学士&#xff0f;看護師資格&#xff0b;8年以上、または修士・PharmD・PhD&#xff0b;6年以上の関連経験</li><li>製薬企業における PMS 実務経験 5 年以上</li><li>クロスファンクショナルな試験・プロジェクトマネジメント経験 4 年以上</li><li>RFP 作成および CRO・ベンダー管理経験</li></ul><h3>知識・スキル</h3><ul><li>疾患・治療領域に関する高度な専門知識</li><li>PMS フルサイクルマネジメントの知識</li><li>J-PSR&#xff0f;再審査資料作成経験</li><li>日本の関連法規、ICH、GPSP に関する十分な理解</li><li>日本語・英語での高いコミュニケーション能力&#xff08;TOEIC 750 点以上&#xff09;</li><li>プロジェクトマネジメント力、チームワーク力、変革対応力</li><li>主体的に業務へ関与でき、必要に応じて出張可能であること</li></ul></div><p style="text-align:inherit"><br /> </p><h2><br /><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span>For Current Gilead Employees and Contractors:</span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></h2><p><span>Please apply via the Internal Career Opportunities portal in Workday.</span></p>