Clinical Program Manager
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Monthly Salary:
Posted on:
6 hours ago
Vacancies:
1 Vacancy
Job Summary
At Gilead were creating a healthier world for all people. For more than 35 years weve 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.
Every member of Gileads 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 were looking for the next wave of passionate and ambitious people ready to make a direct impact.
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.
Job Description
ENGLISH
Position Overview
- 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).
- Clinical Operations is responsible for the worldwide execution of all Phase IIV 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.
- 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.
- The CPM oversees and is responsible for the successful execution of one or multiple studies/programs including financial responsibility.
- The CPM manages study resources through continuous assessment and optimal deployment to support a flexible One Ops workforce.
- 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.
Example Responsibilities
- 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).
- Provide input into short- and long-term therapeutic area and functional strategic and operational plans and support alignment and communication upon implementation.
- 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.
- 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.
- 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.
- Oversee performance and quality of outsourced CRO activities.
- Provide ongoing financial oversight of assigned PMS studies and programs.
- Partner with cross-functional teams to manage and revise project timelines and budgets.
- Ensure study quality and compliance with Work Orders SOPs protocols and Japanese regulatory requirements.
- Prepare training plans and deliver training to internal Therapeutic Specialists and CRO personnel.
- Prepare PMS-related sections of J-PSR and re-examination reports in English and Japanese.
- Manage audits and inspections by regulatory authorities or internal compliance groups.
- Prepare TMF plans and manage document archiving.
- Develop and maintain GPSP SOPs and provide required training.
- Support other non-interventional studies and early-phase (Phase II/III) clinical trials as needed.
Requirements
Minimum Education & Experience
- BA/BS/RN with 8 years of relevant experience
or MA/MS/PharmD/PhD with 6 years of relevant experience - Minimum 5 years of PMS experience in pharmaceutical companies
- At least 4 years of cross-functional study or project management experience
- Experience with RFP development and CRO/vendor selection and oversight
- Strong communication and influencing skills
Knowledge & Other Requirements
- Advanced knowledge of one or more disease or therapeutic areas
- Full-cycle study management experience (start-up to close-out)
- Knowledge of PMS planning and execution
- Experience preparing J-PSR and/or re-examination dossiers
- Basic knowledge of statistical analysis and data management for PMS
- Thorough understanding of Japanese regulations ICH guidelines and GPSP
- Strong Japanese and English communication skills (TOEIC 750)
- Proven project management leadership and change management skills
- Hands-on approach and ability to travel as required
日本語
ManagerCPM Japan Late Phase
グレード: 29
ポジション概要
- 本ポジションは日本の Clinical OperationsClinOps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PMSを成功裡にマネジメントする責任を担います
- 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
- 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
- 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
- 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
- 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
主な職務内容
- 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
- 日本およびグローバル部門と連携しPMS プロトコル日本版 RMP 含むおよび CRF の作成に貢献します
- 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
- 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
- CRO 委託業務の品質およびパフォーマンスを監督します
- PMS臨床試験の財務スケジュール予算管理を行います
- 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
- 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
- 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
- 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
- その他の非介入試験や第 IIIII 相試験の支援を行う場合があります
応募要件
学歴経験
- 学士看護師資格8年以上または修士PharmDPhD6年以上の関連経験
- 製薬企業における PMS 実務経験 5 年以上
- 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
- RFP 作成および CROベンダー管理経験
知識スキル
- 疾患治療領域に関する高度な専門知識
- PMS フルサイクルマネジメントの知識
- J-PSR再審査資料作成経験
- 日本の関連法規ICHGPSP に関する十分な理解
- 日本語英語での高いコミュニケーション能力TOEIC 750 点以上
- 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
- 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
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
Required Experience:
Manager
Key Skills
About Company
Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensu ... View more
